|
1
|
Inoue T, Naitoh I. Updates on Endoscopic Stenting for Unresectable Malignant Hilar Biliary Obstruction. J Clin Med 2024; 13:5410. [PMID: 39336898 PMCID: PMC11432677 DOI: 10.3390/jcm13185410] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/05/2024] [Revised: 09/11/2024] [Accepted: 09/11/2024] [Indexed: 09/30/2024] Open
Abstract
Malignant hilar biliary obstruction (MHBO) can cause obstructive jaundice and/or cholangitis necessitating appropriate biliary drainage. Endoscopic biliary stenting is the first-choice treatment, especially in unresectable cases, owing to its minimally invasive nature and utility. However, the hilar region is complex because of the branching and curving of bile ducts, making strictures in this area more complicated. Therefore, MHBO stenting is challenging, and treatment strategies have yet to be established. Furthermore, recent advances in antitumor therapies have altered the background surrounding the development of stenting strategies. Therefore, it is necessary to understand and grasp the current evidence well and to accumulate additional evidence reflecting the current situation. This study reviews the current status, issues, and prospects of endoscopic stenting for MHBO, especially in unresectable cases.
Collapse
Affiliation(s)
- Tadahisa Inoue
- Department of Gastroenterology, Aichi Medical University, 1-1 Yazakokarimata, Nagakute 480-1195, Aichi, Japan
| | - Itaru Naitoh
- Department of Gastroenterology, Nagoya City University Midori Municipal Hospital, 1-77 Shiomigaoka, Midori-ku, Nagoya 458-0037, Aichi, Japan
| |
Collapse
|
|
2
|
Park Y, Won DS, An JS, Kim SH, Ryu DS, Zeng CH, Kang JM, Kim JW, Kim HS, Park JH, Lee SS. Novel self-expandable stent-based endobiliary radiofrequency ablation for unresectable malignant biliary obstruction. Gastrointest Endosc 2024; 100:557-566.e10. [PMID: 38583543 DOI: 10.1016/j.gie.2024.04.003] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/12/2023] [Revised: 01/25/2024] [Accepted: 04/01/2024] [Indexed: 04/09/2024]
Abstract
BACKGROUND AND AIMS Endobiliary radiofrequency ablation (RFA) is an emerging endoscopic palliative adjunctive therapy used for the local treatment of unresectable malignant biliary obstruction (MBO). However, irregular ablation ranges caused by insufficient electrode-to-bile duct contact pose a significant obstacle. We investigated the feasibility of a self-expandable stent (SES)-based electrode with a customized RFA generator in the porcine liver and common bile duct (CBD). METHODS An SES-RFA system with polarity switching was developed to perform endobiliary RFA. The ablation ranges of 20 ablation protocols were evaluated to validate the feasibility of the newly developed RFA system in the porcine liver. Nine of 20 ablation protocols were selected for evaluation in the porcine CBD with cholangiography, endoscopy, and histologic and immunohistochemical analysis. RESULTS The SES-RFA system with polarity switching was successfully constructed and demonstrated high accuracy and reproducibility. The ablation area was clearly identified between the 2 SESs. The ablation ranges and degree of mucosal damage, including terminal deoxynucleotidyl transferase-mediated dUTP nick and labeling-positive and heat shock protein 70-positive depositions, increased proportionally with ablation protocols in the porcine liver and CBD (all P < .05). Ablation length and depth linearly increased with ablation protocols from 8.74 ± .25 to 31.25 ± .67 mm and 1.61 ± .09 to 11.94 ± .44 mm, respectively. CONCLUSIONS The SES-RFA system with polarity switching between electrodes provided an even circumferential area of ablation and enhanced ablation depth between the electrodes. This novel endobiliary RFA system is a promising modality for local ablation in patients with unresectable MBO.
Collapse
Affiliation(s)
- Yubeen Park
- Biomedical Engineering Research Center, Asan Institute for Life Sciences, Asan Medical Center, Seoul, Republic of Korea; Department of Gastroenterology, Asan Medical Center, Seoul, Republic of Korea
| | - Dong-Sung Won
- Biomedical Engineering Research Center, Asan Institute for Life Sciences, Asan Medical Center, Seoul, Republic of Korea
| | - Jin Su An
- Department of Biomedical Engineering, School of ICT Convergence Engineering, College of Science & Technology, Konkuk University, Chungju-si, Republic of Korea
| | - Song Hee Kim
- Biomedical Engineering Research Center, Asan Institute for Life Sciences, Asan Medical Center, Seoul, Republic of Korea; Department of Gastroenterology, Asan Medical Center, Seoul, Republic of Korea
| | - Dae Sung Ryu
- Biomedical Engineering Research Center, Asan Institute for Life Sciences, Asan Medical Center, Seoul, Republic of Korea; Department of Gastroenterology, Asan Medical Center, Seoul, Republic of Korea
| | - Chu Hui Zeng
- Biomedical Engineering Research Center, Asan Institute for Life Sciences, Asan Medical Center, Seoul, Republic of Korea
| | - Jeon Min Kang
- Biomedical Engineering Research Center, Asan Institute for Life Sciences, Asan Medical Center, Seoul, Republic of Korea
| | - Ji Won Kim
- Biomedical Engineering Research Center, Asan Institute for Life Sciences, Asan Medical Center, Seoul, Republic of Korea; Department of Gastroenterology, Asan Medical Center, Seoul, Republic of Korea
| | - Hyung Sik Kim
- Department of Mechatronics Engineering, School of ICT Convergence Engineering, College of Science & Technology, Konkuk University, Chungju-si, Republic of Korea
| | - Jung-Hoon Park
- Biomedical Engineering Research Center, Asan Institute for Life Sciences, Asan Medical Center, Seoul, Republic of Korea; Department of Convergence Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea
| | - Sang Soo Lee
- Department of Gastroenterology, Asan Medical Center, Seoul, Republic of Korea
| |
Collapse
|
|
3
|
Consensus statements on endoscopic radiofrequency ablation for malignant biliary strictures. J Dig Dis 2024; 25:2-13. [PMID: 38126618 DOI: 10.1111/1751-2980.13248] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/30/2023] [Accepted: 12/19/2023] [Indexed: 12/23/2023]
Abstract
Endoscopy-guided endobiliary radiofrequency ablation has emerged as a novel treatment for malignant biliary strictures in recent years. When combined with biliary stenting and systemic chemotherapy, it can effectively postpone local tumor progression, improve patient's quality of life, and prolong their survival, which is mainly indicated for patients with inoperable extrahepatic cholangiocarcinoma and ampullary cancer. Based on the existing clinical evidence, the Digestive Endoscopology Branch of Chinese Medical Association, the Digestive Endoscopy Professional Committee, Endoscopic Physicians Branch of Chinese Medical Doctor Association, and the National Clinical Research Center for Digestive Diseases (Shanghai) organized relevant experts to discuss the indications, contraindications, technical operation specifications, and prevention and treatment of the complications during endoscopy-guided endobiliary radiofrequency ablation. Consensus statements were established, trying to provide references for standard treatment of malignant biliary tumors in clinical practice.
Collapse
|
|
4
|
Lim S, Truong VG, Jeong S, Lee J, Lee BI, Kang HW. Balloon-assisted laser application for endoscopic treatment of biliary stricture. Lasers Surg Med 2023; 55:912-920. [PMID: 37727929 DOI: 10.1002/lsm.23726] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/21/2023] [Revised: 08/24/2023] [Accepted: 09/09/2023] [Indexed: 09/21/2023]
Abstract
OBJECTIVES Malignant biliary stricture is a ductal narrowing of the bile duct that is often diagnosed at an advanced stage, leading to difficulty in resection. The current study aims to evaluate the feasibility of endobiliary laser treatment by quantifying the extent of coagulative necrosis in tissue under various conditions. METHODS Ex vivo and in vivo porcine bile tissues were used for endobiliary laser treatment to characterize the dosimetric responses of the tissue to various treatment conditions: power level, irradiation time, and number of treatments. 532 nm laser light was coupled with a balloon-integrated diffusing applicator (BDA) to deliver the laser light endoscopically for tissue coagulation. The coagulated regions (maximum length and depth) in the treated tissues were evaluated histologically for quantitative comparison. RESULTS Dosimetric evaluations with ex vivo liver tissue confirmed that both maximum length and depth of coagulative necrosis (CN) increased with applied power and number of treatments. Ex vivo bile duct tests demonstrated that BDA-assisted laser treatment at 10 W for 12 s reproducibly yielded CN with a length of 5.8 ± 1.6 mm and a depth of 0.6 ± 0.2 mm. In vivo tests presented that endoscopic laser treatment using the BDA created CN on the ductal surface without any perforation. Microscopic examinations revealed that a dense inflammatory cell infiltration and eosinophilic area in the in vivo treated tissue. The extent of CN in the in vivo tissue was 40% longer and 120% deeper (length: 8.1 ± 0.7 mm; depth: 1.3 ± 0.2 mm), compared to that in the ex vivo tissue. CONCLUSION BDA-assisted laser treatment could be a feasible option for endoscopic treatment of biliary stricture with uniform ablation at the circumference of bile duct. Further in vivo studies will be performed in a large number of stricture-developed porcine models to examine both efficacy and safety of the proposed endobiliary laser treatment for clinical translations.
Collapse
Affiliation(s)
- Seonghee Lim
- Industry 4.0 Convergence Bionics Engineering, Pukyong National University, Busan, South Korea
| | - Van Gia Truong
- Division of Research and Development, TeCure, Inc., Busan, South Korea
| | - Seok Jeong
- Division of Gastroenterology, Department of Internal Medicine, Inha University School of Medicine, Inha University Hospital, Incheon, South Korea
| | - Jiho Lee
- Division of Smart Healthcare, Major of Biomedical Engineering, College of Information Technology and Convergence, Pukyong National University, Busan, South Korea
| | - Byeong-Il Lee
- Industry 4.0 Convergence Bionics Engineering, Pukyong National University, Busan, South Korea
- Division of Smart Healthcare, Major of Human-Bio Convergence, College of Information Technology and Convergence, Pukyong National University, Busan, South Korea
| | - Hyun Wook Kang
- Industry 4.0 Convergence Bionics Engineering, Pukyong National University, Busan, South Korea
- Division of Research and Development, TeCure, Inc., Busan, South Korea
- Division of Smart Healthcare, Major of Biomedical Engineering, College of Information Technology and Convergence, Pukyong National University, Busan, South Korea
- Marine-integrated Biomedical Technology Center, Pukyong National University, Busan, South Korea
| |
Collapse
|
|
5
|
Inoue T, Ibusuki M, Kitano R, Ito K. Long-term disease control by endobiliary radiofrequency ablation in localized extrahepatic cholangiocarcinoma: a first case report. Clin J Gastroenterol 2023; 16:908-912. [PMID: 37615832 DOI: 10.1007/s12328-023-01845-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/18/2023] [Accepted: 08/08/2023] [Indexed: 08/25/2023]
Abstract
An 84-year-old woman with cerebrovascular disease, dementia, and chronic kidney disease developed jaundice because of localized extrahepatic cholangiocarcinoma (eCCA) at the lower bile duct. Aggressive treatment, including surgery and chemotherapy, was difficult because of the underlying disease; therefore, only metal stent placement with endobiliary radiofrequency ablation (RFA) was performed. Subsequently, six additional RFA sessions were performed 12, 16, 24, 27, 33, and 36 months after the initial RFA using the same settings as the first RFA session. All these procedures were performed for tumor ingrowth. Computed tomography performed 42 months after the initial procedure revealed no stent with stricture resolution and no other metastatic lesion. Thereafter, no recurrence or adverse events have been observed with persisting stent-free status until the reporting of this study (72 months after the initial procedure). This is the first report of a stent-free status and long-term survival in a patient with localized eCCA that was achieved using only endobiliary RFA without any other anti-tumor treatment. Although several problems and issues associated with endobiliary RFA remain unelucidated, it may be a useful therapeutic option for early and localized eCCA in poor surgical candidates.
Collapse
Affiliation(s)
- Tadahisa Inoue
- Department of Gastroenterology, Aichi Medical University, 1-1 Yazakokarimata, Nagakute, Aichi, 480-1195, Japan.
| | - Mayu Ibusuki
- Department of Gastroenterology, Aichi Medical University, 1-1 Yazakokarimata, Nagakute, Aichi, 480-1195, Japan
| | - Rena Kitano
- Department of Gastroenterology, Aichi Medical University, 1-1 Yazakokarimata, Nagakute, Aichi, 480-1195, Japan
| | - Kiyoaki Ito
- Department of Gastroenterology, Aichi Medical University, 1-1 Yazakokarimata, Nagakute, Aichi, 480-1195, Japan
| |
Collapse
|
|
6
|
Inoue T, Yoneda M. Endoscopic intraductal radiofrequency ablation for extrahepatic cholangiocarcinoma: An update (2023). World J Gastrointest Endosc 2023; 15:440-446. [PMID: 37397976 PMCID: PMC10308276 DOI: 10.4253/wjge.v15.i6.440] [Citation(s) in RCA: 4] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/27/2022] [Revised: 02/15/2023] [Accepted: 05/12/2023] [Indexed: 06/14/2023] Open
Abstract
Recently, endoscopic intraductal radiofrequency ablation (ID-RFA) has attracted attention as a local treatment method for malignant biliary obstruction (MBO). ID-RFA causes coagulative necrosis of the tumor tissue in the stricture and induces exfoliation. Its effects are expected to extend the patency period of biliary stents and prolong the survival period. Evidence for extrahepatic cholangiocarcinoma (eCCA) is gradually accumulating, and some reports show significant therapeutic effects in eCCA patients without distant metastasis. However, it is still far from an established treatment technique, and many unsolved problems remain. Therefore, when performing ID-RFA in clinical practice, it is necessary to understand and grasp the current evidence well and to operate appropriately for the true benefit of the patients. This paper reviews the current status, issues, and prospects of endoscopic ID-RFA for MBO, especially for eCCA.
Collapse
Affiliation(s)
- Tadahisa Inoue
- Department of Gastroenterology, Aichi Medical University, Nagakute 480-1195, Aichi, Japan
| | - Masashi Yoneda
- Department of Gastroenterology, Aichi Medical University, Nagakute 480-1195, Aichi, Japan
| |
Collapse
|
|
7
|
Inoue T, Yoneda M. Recent Updates on Local Ablative Therapy Combined with Chemotherapy for Extrahepatic Cholangiocarcinoma: Photodynamic Therapy and Radiofrequency Ablation. Curr Oncol 2023; 30:2159-2168. [PMID: 36826127 PMCID: PMC9954800 DOI: 10.3390/curroncol30020166] [Citation(s) in RCA: 6] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/30/2022] [Revised: 01/25/2023] [Accepted: 02/06/2023] [Indexed: 02/12/2023] Open
Abstract
Although chemotherapy constitutes of the first-line standard therapy for unresectable extrahepatic cholangiocarcinoma, the treatment outcomes are unsatisfactory. In recent years, local ablative therapy, which is delivered to the cholangiocarcinoma lesion via the percutaneous or endoscopic approach, has garnered attention for the treatment of unresectable, extrahepatic cholangiocarcinoma. Local ablative therapy, such as photodynamic therapy and radiofrequency ablation, can achieve local tumor control. A synergistic effect may also be expected when local ablative therapy is combined with chemotherapy. However, it is a long way from being entrenched as an established therapeutic technique, and several unresolved problems persist, including the paucity of evidence comparing photodynamic therapy and radiofrequency ablation. Clinical application of photodynamic therapy and radiofrequency ablation requires sound comprehension and assimilation of the available evidence to truly benefit each individual patient. In this study, we reviewed the current status, issues, and future prospects of photodynamic therapy and radiofrequency ablation for extrahepatic cholangiocarcinoma, with a special focus on their combination with chemotherapy.
Collapse
Affiliation(s)
- Tadahisa Inoue
- Department of Gastroenterology, Aichi Medical University, 1-1 Yazakokarimata, Nagakute 480-1195, Japan
| | | |
Collapse
|
|
8
|
Inoue T, Ibusuki M, Kitano R, Sakamoto K, Kimoto S, Kobayashi Y, Sumida Y, Nakade Y, Ito K, Yoneda M. Endoscopic radiofrequency ablation for ingrowth occlusion after bilateral metal stent placement for malignant hilar biliary obstruction: a prospective pilot study. Gastrointest Endosc 2023; 97:282-290.e1. [PMID: 36220379 DOI: 10.1016/j.gie.2022.09.025] [Citation(s) in RCA: 5] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/27/2022] [Revised: 09/20/2022] [Accepted: 09/26/2022] [Indexed: 01/28/2023]
Abstract
BACKGROUND AND AIMS Endoscopic biliary radiofrequency ablation (RFA) may be an option for the treatment of ingrowth occlusion after self-expandable metal stent (SEMS) deployment; however, its utility remains uncertain. This study aimed to examine the feasibility of RFA for the palliation of ingrowth after bilateral SEMS placement in patients with malignant hilar biliary obstruction. METHODS This prospective, single-center, pilot study enrolled 30 patients who met the eligibility criteria between April 2020 and March 2022. Study outcomes were technical success, clinical success, recurrent biliary obstruction (RBO), and adverse events (AEs) besides RBO associated with RFA for ingrowth occlusion. Furthermore, factors predictive of clinical success were evaluated. RESULTS Technical and clinical success rates were 93.3% (28/30) and 71.4% (20/28), respectively. The rates of early and late AEs were 6.7% (2/30) and 10.0% (2/20), respectively. The incidence rate of RBO after RFA was 45.0% (9/20), and the median time to RBO was 163 days. Multivariate analysis of the factors affecting clinical success revealed a positive association between the recanalization diameter on the ingrown part within the SEMS (odds ratio, 1.13; 95% confidence interval, 1.01-1.26; P = .038). The calculated optimal cutoff for the ratio of the recanalization diameter to the SEMS diameter for predicting clinical success was 51.1%. CONCLUSIONS Endoscopic biliary RFA elicited promising results, with good long-term stent patency and without the requirement of any additional stent placement, for the palliation of ingrowth occlusion after bilateral SEMS placement. However, the clinical success rate was insufficient, necessitating improvements in the future. (Clinical trial registration number: UMIN000040154.).
Collapse
Affiliation(s)
- Tadahisa Inoue
- Department of Gastroenterology, Aichi Medical University, Aichi, Japan
| | - Mayu Ibusuki
- Department of Gastroenterology, Aichi Medical University, Aichi, Japan
| | - Rena Kitano
- Department of Gastroenterology, Aichi Medical University, Aichi, Japan
| | - Kazumasa Sakamoto
- Department of Gastroenterology, Aichi Medical University, Aichi, Japan
| | - Satoshi Kimoto
- Department of Gastroenterology, Aichi Medical University, Aichi, Japan
| | - Yuji Kobayashi
- Department of Gastroenterology, Aichi Medical University, Aichi, Japan
| | - Yoshio Sumida
- Department of Gastroenterology, Aichi Medical University, Aichi, Japan
| | - Yukiomi Nakade
- Department of Gastroenterology, Aichi Medical University, Aichi, Japan
| | - Kiyoaki Ito
- Department of Gastroenterology, Aichi Medical University, Aichi, Japan
| | - Masashi Yoneda
- Department of Gastroenterology, Aichi Medical University, Aichi, Japan
| |
Collapse
|
|
9
|
Inoue T, Kutsumi H, Ibusuki M, Yoneda M. Endoscopic biliary ethanol ablation using a novel multi-hole balloon catheter: In vivo feasibility study in a swine model. PLoS One 2023; 18:e0283733. [PMID: 37000862 PMCID: PMC10065430 DOI: 10.1371/journal.pone.0283733] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/12/2023] [Accepted: 03/15/2023] [Indexed: 04/03/2023] Open
Abstract
BACKGROUND Minimally invasive local treatment could be a good option for the treatment of extrahepatic cholangiocarcinoma (eCCA). This study aimed to evaluate the feasibility of a novel local treatment method, endoscopic biliary ethanol ablation (EA), in vivo using a swine model. METHODS This study utilized a prototype of the newly developed multi-hole balloon catheter. The swine bile duct was ablated using this balloon via the same approach as the conventional endoscopic retrograde cholangiography procedure. The study outcomes included technical success, clinical success, and adverse events associated with endoscopic biliary EA. RESULTS Fourteen miniature pigs underwent endoscopic biliary EA. Technical success was achieved for all endoscopic EA procedures without any hindrance. All pigs were reared and followed up for a median 35-day period after the procedure. No change was observed in the bile duct wall in one case, in which sufficient contact was not achieved between the balloon and bile duct wall. Except for this case, stricture formation occurred at the site of ablation, where the epithelium was sloughed and necrosis with denaturation replaced the granulation tissue and fibrotic changes. The median length and depth of the ablation area were 17.05 and 2.21 mm, respectively. No adverse events were observed, except for the formation of bile duct strictures and sequelae associated with strictures. CONCLUSIONS This preliminary study was the first to report endoscopic biliary EA using a novel multi-hole balloon catheter, which demonstrated technical feasibility and potential for the treatment for eCCA.
Collapse
Affiliation(s)
- Tadahisa Inoue
- Department of Gastroenterology, Aichi Medical University, Nagakute, Aichi, Japan
- * E-mail:
| | - Hiromu Kutsumi
- Center for Clinical Research and Advance Medicine, Shiga University of Medical Science, Seta Tsukinowa-cho, Otsu, Shiga, Japan
| | - Mayu Ibusuki
- Department of Gastroenterology, Aichi Medical University, Nagakute, Aichi, Japan
| | - Masashi Yoneda
- Department of Gastroenterology, Aichi Medical University, Nagakute, Aichi, Japan
| |
Collapse
|
|
10
|
Pimpinelli M, Makar M, Kahaleh M. Endoscopic management of benign and malignant hilar stricture. Dig Endosc 2022; 35:443-452. [PMID: 36453003 DOI: 10.1111/den.14487] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/21/2022] [Accepted: 11/28/2022] [Indexed: 12/03/2022]
Abstract
Management of hilar strictures pose a significant challenge for endoscopists. Several strategies have been demonstrated in the last decade beyond decompression, however, there remains controversy and minimal consensus in the literature. This review seeks to summarize the current literature and discuss emerging therapies, such as photodynamic therapy and radiofrequency ablation.
Collapse
Affiliation(s)
- Marcella Pimpinelli
- Department of Gastroenterology and Hepatology, Rutgers Robert Wood Johnson Medical School, New Brunswick, USA
| | - Michael Makar
- Department of Gastroenterology and Hepatology, Rutgers Robert Wood Johnson Medical School, New Brunswick, USA
| | - Michel Kahaleh
- Department of Gastroenterology and Hepatology, Rutgers Robert Wood Johnson Medical School, New Brunswick, USA
| |
Collapse
|
|
11
|
Kim SH, Jeong S, Kang JM, Park Y, Ryu DS, Won DS, Kim JW, Zeng CH, Kim HS, Kim HB, Lee SS, Park JH. Image-guided stent-directed irreversible electroporation for circumferential ablation in the rat esophagus. Front Bioeng Biotechnol 2022; 10:934858. [PMID: 36466325 PMCID: PMC9712177 DOI: 10.3389/fbioe.2022.934858] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/17/2022] [Accepted: 10/31/2022] [Indexed: 06/08/2024] Open
Abstract
Background: Irreversible electroporation (IRE) has been investigated in the alimentary tract; however, the lack of dedicated electrodes and insufficient tissue responses made its application limited. The aim of this study was to investigate the efficacy and safety of image-guided stent-directed IRE in the rat esophagus. Methods: The bipolar self-expandable electrode (SE) was developed using the braiding technique. A finite element analysis was performed to validate optimal electrical field strength for the rat esophagus. A total of 40 out of 50 rats received stent-directed IRE and were sacrificed at 10 h, 3 days, 7 days, and 28 days of 10 each. The remaining ten rats underwent a sham procedure. The outcomes of stent-directed IRE were assessed by esophagography and histological responses. Results: Stent-directed IRE was technically successful in all rats with mild muscle contraction. The heart rate dropped immediately and gradually recovered at 180 s. TUNEL and caspase-3 with submucosal thickness significantly increased at 10 h and Day 3 compared with those of the sham control (all p < 0.001). The thickness of epithelial layers with collagen deposition significantly decreased at 10 h and Day 3 (all p < 0.001), however, increased at Day 7 compared with that of the sham control (all p < 0.05). The Ki67-positive deposition significantly increased at Day 3 and 7 compared with that of the sham control (all p < 0.001). All variables were similar to those of the sham control at Day 28. Conclusion: Image-guided stent-directed IRE was effective and safe in the rat esophagus. It seems to have effectively and evenly induced cell death and gradually recovered with cellular regeneration.
Collapse
Affiliation(s)
- Song Hee Kim
- Biomedical Engineering Research Center, Asan Institute for Life Sciences, Asan Medical Center, Seoul, South Korea
- Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea
| | - Seung Jeong
- Department of Biosystems and Biomaterials Science and Engineering, Seoul National University, Seoul, South Korea
| | - Jeon Min Kang
- Biomedical Engineering Research Center, Asan Institute for Life Sciences, Asan Medical Center, Seoul, South Korea
| | - Yubeen Park
- Biomedical Engineering Research Center, Asan Institute for Life Sciences, Asan Medical Center, Seoul, South Korea
- Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea
| | - Dae Sung Ryu
- Biomedical Engineering Research Center, Asan Institute for Life Sciences, Asan Medical Center, Seoul, South Korea
| | - Dong-Sung Won
- Biomedical Engineering Research Center, Asan Institute for Life Sciences, Asan Medical Center, Seoul, South Korea
| | - Ji Won Kim
- Biomedical Engineering Research Center, Asan Institute for Life Sciences, Asan Medical Center, Seoul, South Korea
- Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea
| | - Chu Hui Zeng
- Biomedical Engineering Research Center, Asan Institute for Life Sciences, Asan Medical Center, Seoul, South Korea
| | - Hyung-Sik Kim
- Department of Mechatronics Engineering, School of ICT Convergence Engineering, College of Science and Technology, Konkuk University, Chungju-si, South Korea
| | - Hong Bae Kim
- Department of Biosystems and Biomaterials Science and Engineering, Seoul National University, Seoul, South Korea
| | - Sang Soo Lee
- Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea
| | - Jung-Hoon Park
- Biomedical Engineering Research Center, Asan Institute for Life Sciences, Asan Medical Center, Seoul, South Korea
| |
Collapse
|
|
12
|
Won DS, Park Y, An J, Ryu DS, Kang JM, Kim JW, Kim SH, Zeng CH, Kim H, Kim HS, Park JH, Lee SS. Stent-based electrode for radiofrequency ablation in the rat esophagus: a preliminary study. Sci Rep 2022; 12:19135. [PMID: 36352051 PMCID: PMC9646798 DOI: 10.1038/s41598-022-23472-7] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/14/2022] [Accepted: 11/01/2022] [Indexed: 11/10/2022] Open
Abstract
Endoluminal radiofrequency (RF) ablation has been widely used as a safe and effective treatment for Barrett's esophagus. However, inadequate RF ablation may occur due to insufficient contact between the electrode and target tissues. Herein, a stent-based monopolar RF electrode (SE) was developed to evenly deliver RF energy to the inner wall of the rat esophagus. The optimal RF parameters were evaluated in the exposed rat esophagus. The temperature in the rat esophagus reached 70 ℃ in 89 s at 30 W, 59 s at 40 W, and 34 s at 50 W. The technical feasibility and efficacy of RF ablation using SE were evaluated based on changes in histological transformation and immunohistochemical parameters of tissues compared at immediately, 1 and 2 weeks after the procedure. The degrees of inflammatory cell infiltration, fibrotic changes, TUNEL, and HSP70 in the RF-ablated rat esophagus were significantly higher than compared with sham control (all p < 0.05). TUNEL-positive deposition gradually decreased, but HSP 70-positive deposition maintained a similar level for 2 weeks. The stent-based RF ablation was technically feasible and effective in evenly inducing thermal damages to the rat esophagus. The RF ablation system using the SE may represent a promising treatment for endoluminal malignancies.
Collapse
Affiliation(s)
- Dong-Sung Won
- Biomedical Engineering Research Center, Asan Institute for Life Sciences, Asan Medical Center, 88 Olympic-Ro 43-Gil, Songpa-Gu, Seoul, 05505, Republic of Korea
| | - Yubeen Park
- Biomedical Engineering Research Center, Asan Institute for Life Sciences, Asan Medical Center, 88 Olympic-Ro 43-Gil, Songpa-Gu, Seoul, 05505, Republic of Korea
- Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-Ro 43-Gil, Songpa-Gu, Seoul, 05505, Republic of Korea
| | - Jinsu An
- Department of Biomedical Engineering, School of ICT Convergence Engineering, College of Science & Technology, Konkuk University, Chungju, Republic of Korea
| | - Dae Sung Ryu
- Biomedical Engineering Research Center, Asan Institute for Life Sciences, Asan Medical Center, 88 Olympic-Ro 43-Gil, Songpa-Gu, Seoul, 05505, Republic of Korea
| | - Jeon Min Kang
- Biomedical Engineering Research Center, Asan Institute for Life Sciences, Asan Medical Center, 88 Olympic-Ro 43-Gil, Songpa-Gu, Seoul, 05505, Republic of Korea
| | - Ji Won Kim
- Biomedical Engineering Research Center, Asan Institute for Life Sciences, Asan Medical Center, 88 Olympic-Ro 43-Gil, Songpa-Gu, Seoul, 05505, Republic of Korea
- Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-Ro 43-Gil, Songpa-Gu, Seoul, 05505, Republic of Korea
| | - Song Hee Kim
- Biomedical Engineering Research Center, Asan Institute for Life Sciences, Asan Medical Center, 88 Olympic-Ro 43-Gil, Songpa-Gu, Seoul, 05505, Republic of Korea
- Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-Ro 43-Gil, Songpa-Gu, Seoul, 05505, Republic of Korea
| | - Chu Hui Zeng
- Biomedical Engineering Research Center, Asan Institute for Life Sciences, Asan Medical Center, 88 Olympic-Ro 43-Gil, Songpa-Gu, Seoul, 05505, Republic of Korea
| | - Hongbae Kim
- Department of Biosystems & Biomaterials Science and Engineering, Seoul National University, Seoul, 08826, Republic of Korea
| | - Hyung-Sik Kim
- Department of Mechatronics Engineering, School of ICT Convergence Engineering, College of Science & Technology, Konkuk University, Chungju, Republic of Korea
| | - Jung-Hoon Park
- Biomedical Engineering Research Center, Asan Institute for Life Sciences, Asan Medical Center, 88 Olympic-Ro 43-Gil, Songpa-Gu, Seoul, 05505, Republic of Korea.
| | - Sang Soo Lee
- Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-Ro 43-Gil, Songpa-Gu, Seoul, 05505, Republic of Korea.
| |
Collapse
|
|
13
|
Inoue T, Naitoh I, Kitano R, Ibusuki M, Kobayashi Y, Sumida Y, Nakade Y, Ito K, Yoneda M. Endobiliary Radiofrequency Ablation Combined with Gemcitabine and Cisplatin in Patients with Unresectable Extrahepatic Cholangiocarcinoma. Curr Oncol 2022; 29:2240-2251. [PMID: 35448156 PMCID: PMC9029596 DOI: 10.3390/curroncol29040182] [Citation(s) in RCA: 11] [Impact Index Per Article: 3.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/15/2022] [Revised: 03/16/2022] [Accepted: 03/19/2022] [Indexed: 12/16/2022] Open
Abstract
Background: Endobiliary radiofrequency ablation (RFA) is a promising treatment modality for patients with extrahepatic cholangiocarcinoma (eCCA). However, no study has investigated the combined use of endobiliary RFA and gemcitabine plus cisplatin (GC) chemotherapy. This study aimed to examine the feasibility and efficacy of endobiliary RFA with GC therapy for patients with unresectable eCCA. Methods: The study outcomes included overall survival (OS), progression-free survival (PFS), time to recurrent biliary obstruction (RBO), and adverse events associated with the treatment. These parameters were retrospectively compared between 25 patients who underwent RFA with self-expandable metal stent (SEMS) placement followed by GC therapy (with-RFA group) and a control cohort of 25 patients who underwent SEMS placement alone and GC therapy (without-RFA group). Results: The median time to RBO was significantly longer in the with-RFA group (10.7 versus 5.2 months, p = 0.048). The median OS was significantly higher in patients with locally advanced tumors in the with-RFA group (23.1 versus 16.6 months, p = 0.032), but did not differ significantly in patients with metastasis (11.4 versus 8.5 months, p = 0.180). Similarly, the median PFS was significantly higher in the with-RFA group in patients with locally advanced disease (10.1 versus 7.3 months, p = 0.015), while there was no significant difference in patients with metastasis (5.4 versus 4.4 months, p = 0.529). The rates of various toxicities did not differ significantly between the groups. Conclusions: Endobiliary RFA prolonged the patency period of uncovered SEMS combined with GC therapy in patients with eCCA. Although RFA also yielded survival benefits, its effect was restricted to locally advanced tumors.
Collapse
Affiliation(s)
- Tadahisa Inoue
- Department of Gastroenterology, Aichi Medical University, 1-1 Yazakokarimata, Nagakute 480-1195, Japan; (R.K.); (M.I.); (Y.K.); (Y.S.); (Y.N.); (K.I.); (M.Y.)
- Correspondence: ; Tel.: +81-561-62-3311; Fax: +81-561-63-3208
| | - Itaru Naitoh
- Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan;
| | - Rena Kitano
- Department of Gastroenterology, Aichi Medical University, 1-1 Yazakokarimata, Nagakute 480-1195, Japan; (R.K.); (M.I.); (Y.K.); (Y.S.); (Y.N.); (K.I.); (M.Y.)
| | - Mayu Ibusuki
- Department of Gastroenterology, Aichi Medical University, 1-1 Yazakokarimata, Nagakute 480-1195, Japan; (R.K.); (M.I.); (Y.K.); (Y.S.); (Y.N.); (K.I.); (M.Y.)
| | - Yuji Kobayashi
- Department of Gastroenterology, Aichi Medical University, 1-1 Yazakokarimata, Nagakute 480-1195, Japan; (R.K.); (M.I.); (Y.K.); (Y.S.); (Y.N.); (K.I.); (M.Y.)
| | - Yoshio Sumida
- Department of Gastroenterology, Aichi Medical University, 1-1 Yazakokarimata, Nagakute 480-1195, Japan; (R.K.); (M.I.); (Y.K.); (Y.S.); (Y.N.); (K.I.); (M.Y.)
| | - Yukiomi Nakade
- Department of Gastroenterology, Aichi Medical University, 1-1 Yazakokarimata, Nagakute 480-1195, Japan; (R.K.); (M.I.); (Y.K.); (Y.S.); (Y.N.); (K.I.); (M.Y.)
| | - Kiyoaki Ito
- Department of Gastroenterology, Aichi Medical University, 1-1 Yazakokarimata, Nagakute 480-1195, Japan; (R.K.); (M.I.); (Y.K.); (Y.S.); (Y.N.); (K.I.); (M.Y.)
| | - Masashi Yoneda
- Department of Gastroenterology, Aichi Medical University, 1-1 Yazakokarimata, Nagakute 480-1195, Japan; (R.K.); (M.I.); (Y.K.); (Y.S.); (Y.N.); (K.I.); (M.Y.)
| |
Collapse
|
|
14
|
Iwasaki E. Inoperable duodenal ampullary carcinoma: Can endoscopic radiofrequency ablation therapy be a promising palliative treatment in the future? Dig Endosc 2022; 34:466-468. [PMID: 34994007 DOI: 10.1111/den.14212] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/27/2021] [Revised: 11/10/2021] [Accepted: 12/06/2021] [Indexed: 02/08/2023]
Affiliation(s)
- Eisuke Iwasaki
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan
| |
Collapse
|
|
15
|
Percutaneous Endoluminal Radiofrequency Ablation of Occluded Biliary Metal Stent in Malignancy Using Monopolar Technique: A Feasibility Study. Cardiovasc Intervent Radiol 2022; 45:873-878. [PMID: 35217890 DOI: 10.1007/s00270-022-03097-z] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/19/2021] [Accepted: 02/08/2022] [Indexed: 11/02/2022]
Abstract
PURPOSE To prove feasibility and safety of percutaneous endoluminal radiofrequency ablation (eRFA) using a monopolar approach in treatment of occluded biliary stent in malignancy. MATERIALS AND METHODS The study included 11 patients with occluded biliary metal stent that had been implanted due to malignant biliary obstruction. All underwent metal stent recanalization by percutaneous eRFA in monopolar setting. Sixteen eRFA procedures were performed under fluoroscopic guidance with an EndoHPB 8F radiofrequency ablation catheter. The effect of stent recanalization was assessed based upon change from pre- to post-procedural diameter of the patent lumen of the metal stent (Wilcoxon test), primary and secondary stent patency (compared by log-rank test), catheter-free period, and overall survival. Adverse events were evaluated according to Common Terminology Criteria for Adverse Events (CTCEA) 4.0. RESULTS Recanalization of the metal stent by monopolar radiofrequency ablation was successful in all 11 patients. Diameter of the patent lumen of the stent significantly widened after the eRFA inside the stent (median 2 vs. 7 mm, p = 0.003). Grade 1 complications were observed in one-third of procedures. Median stent patency after recanalization by eRFA was non-inferior to primary metal stent patency (154 vs. 161 days, p = 0.27). Median catheter-free survival and overall survival after stent recanalization were 149 and 210 days, respectively. CONCLUSION Endoluminal radiofrequency ablation in monopolar setting was shown to be a feasible and safe method for recanalization of occluded biliary metal stents. LEVEL OF EVIDENCE Level 4, Case Series.
Collapse
|
|
16
|
Inoue T, Yoneda M. Updated evidence on the clinical impact of endoscopic radiofrequency ablation in the treatment of malignant biliary obstruction. Dig Endosc 2022; 34:345-358. [PMID: 34107114 DOI: 10.1111/den.14059] [Citation(s) in RCA: 29] [Impact Index Per Article: 9.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/11/2021] [Revised: 05/24/2021] [Accepted: 06/08/2021] [Indexed: 12/15/2022]
Abstract
Endoscopic biliary radiofrequency ablation (RFA) was recently developed as a novel adjunctive procedure and a promising therapeutic option in patients with malignant biliary obstruction (MBO). RFA can achieve local tumor control, resulting in improved biliary stent patency and a potential survival benefit. However, the efficacy of biliary RFA remains controversial, and previous studies have shown conflicting results. At present, extrahepatic cholangiocarcinoma is considered the condition most effectively treated by biliary RFA, but there is limited research even on this point. Further, limitations of RFA associated with the devices used during the procedure are an important subject of discussion. In addition to further well-designed clinical trials, development of innovative devices is warranted to investigate and conclusively establish the usefulness of biliary RFA. In this review we summarize the updated evidence regarding the use of endoscopic biliary RFA for MBO and discuss issues that should be addressed in future studies.
Collapse
Affiliation(s)
- Tadahisa Inoue
- Department of Gastroenterology, Aichi Medical University, Aichi, Japan
| | - Masashi Yoneda
- Department of Gastroenterology, Aichi Medical University, Aichi, Japan
| |
Collapse
|
|
17
|
Jarosova J, Macinga P, Hujova A, Kral J, Urban O, Spicak J, Hucl T. Endoscopic radiofrequency ablation for malignant biliary obstruction. World J Gastrointest Oncol 2021; 13:1383-1396. [PMID: 34721772 PMCID: PMC8529920 DOI: 10.4251/wjgo.v13.i10.1383] [Citation(s) in RCA: 9] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/21/2021] [Revised: 06/17/2021] [Accepted: 08/24/2021] [Indexed: 02/06/2023] Open
Abstract
Cholangiocarcinoma and pancreatic cancer are the most common causes of malignant biliary obstruction. The majority of patients are diagnosed at a late stage when surgical resection is rarely possible. In these cases, palliative chemotherapy and radiotherapy provide only limited benefit and are associated with poor survival. Radiofrequency ablation (RFA) is a procedure for locoregional control of tumours, whereby a high-frequency alternating current turned into thermal energy causes coagulative necrosis of the tissue surrounding the catheter. The subsequent release of debris and tumour antigens by necrotic cells can stimulate local and systemic immunity. The development of endoluminal RFA catheters has led to the emergence of endoscopically delivered RFA, a treatment mainly used for malignant biliary strictures to prolong survival and/or stent patency. Other indications include recanalisation of occluded biliary stents and treatment of intraductal ampullary adenoma or benign biliary strictures. This article presents a comprehensive review of endobiliary RFA, mainly focusing on its use in patients with malignant biliary obstruction. The available data suggest that biliary RFA may be a promising modality, having positive impacts on survival and stent patency and boasting a reasonable safety profile. However, further studies with better characterised and stratified patient populations are needed before the method becomes accepted within routine clinical practice.
Collapse
Affiliation(s)
- Jana Jarosova
- Department of Gastroenterology and Hepatology, Institute for Clinical and Experimental Medicine, Praha 14021, Czech Republic
| | - Peter Macinga
- Department of Gastroenterology and Hepatology, Institute for Clinical and Experimental Medicine, Praha 14021, Czech Republic
| | - Alzbeta Hujova
- Department of Gastroenterology and Hepatology, Institute for Clinical and Experimental Medicine, Praha 14021, Czech Republic
| | - Jan Kral
- Department of Gastroenterology and Hepatology, Institute for Clinical and Experimental Medicine, Praha 14021, Czech Republic
| | - Ondrej Urban
- Department of Internal Medicine II – Gastroenterology and Geriatrics, University Hospital Olomouc, Faculty of Medicine and Dentristry, Palacky University Olomouc, Olomouc 77900, Czech Republic
| | - Julius Spicak
- Department of Gastroenterology and Hepatology, Institute for Clinical and Experimental Medicine, Praha 14021, Czech Republic
| | - Tomas Hucl
- Department of Gastroenterology and Hepatology, Institute for Clinical and Experimental Medicine, Praha 14021, Czech Republic
| |
Collapse
|
|
18
|
Endoscopic Ultrasound-Guided Antegrade Radiofrequency Ablation and Metal Stenting With Hepaticoenterostomy for Malignant Biliary Obstruction: A Prospective Preliminary Study. Clin Transl Gastroenterol 2021; 11:e00250. [PMID: 33108126 PMCID: PMC7566866 DOI: 10.14309/ctg.0000000000000250] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/15/2022] Open
Abstract
Endobiliary radiofrequency ablation (RFA) for malignant biliary obstruction is a promising option for improving biliary stent patency, but its efficacy and safety with endoscopic ultrasound (EUS)-guided biliary drainage are uncertain. We examined the feasibility of EUS-guided hepaticoenterostomy with antegrade stenting (EUS-HEAS) and RFA in patients with unresectable malignant biliary obstruction.
Collapse
|
|
19
|
Inoue T, Kutsumi H, Ibusuki M, Yoneda M. Feasibility of balloon-based endobiliary radiofrequency ablation under cholangioscopy guidance in a swine model. Sci Rep 2021; 11:14254. [PMID: 34244576 PMCID: PMC8270987 DOI: 10.1038/s41598-021-93643-5] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/28/2021] [Accepted: 06/29/2021] [Indexed: 02/07/2023] Open
Abstract
Although endobiliary radiofrequency ablation (RFA) has demonstrated considerable potential for the treatment of biliary strictures, conventional catheter RFA has several limitations. This study aimed to evaluate the feasibility of a novel cholangioscopy (CS)-guided balloon-based RFA procedure in vivo using a swine model. CS-guided balloon-RFA was performed under endoscopic retrograde cholangiography guidance at target temperatures of 60 ℃ or 70 ℃, which were maintained for 60 s. We evaluated the technical feasibility, adverse events, and histological effects associated with the procedure. Twelve sites were ablated in seven miniature pigs. The CS-guided balloon-RFA procedure was technically successful in all cases without any hindrance. Mucosal changes could be detected during RFA, and the ablation area was identified on CS. Necropsy was performed in four pigs on the same day as the procedure: the tissue samples showed coagulative necrosis, and the entire internal circumference of the bile duct was uniformly ablated. The mean lengths of the ablation area in the samples ablated at 60 °C and 70 °C were 20.64 and 22.18 mm, respectively, while the mean depths were 3.46 and 5.07 mm, respectively. The other three pigs were reared and euthanized and autopsied 35 days after the procedure. The site to be ablated had replaced the granulation tissue and fibrotic changes. No adverse events were observed in any case. CS-guided balloon-RFA appears to be a promising option for treating biliary strictures. This preliminary study could pave the way for the evaluation of this procedure in future human clinical trials.
Collapse
Affiliation(s)
- Tadahisa Inoue
- Department of Gastroenterology, Aichi Medical University, 1-1 Yazakokarimata, Nagakute, Aichi, 480-1195, Japan.
| | - Hiromu Kutsumi
- Center for Clinical Research and Advance Medicine, Shiga University of Medical Science, Seta Tsukinowa-Cho, Otsu, Shiga, 520-2192, Japan
| | - Mayu Ibusuki
- Department of Gastroenterology, Aichi Medical University, 1-1 Yazakokarimata, Nagakute, Aichi, 480-1195, Japan
| | - Masashi Yoneda
- Department of Gastroenterology, Aichi Medical University, 1-1 Yazakokarimata, Nagakute, Aichi, 480-1195, Japan
| |
Collapse
|
|
20
|
Inoue T, Yoneda M. Evaluating the tissue effects of balloon-based endobiliary radiofrequency ablation in porcine bile ducts. Int J Hyperthermia 2021; 37:1383-1385. [PMID: 33327820 DOI: 10.1080/02656736.2020.1859627] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/20/2022] Open
Abstract
BACKGROUND We developed a novel balloon-based endobiliary radiofrequency ablation (RFA) system to overcome the limitations of conventional RFA in treating malignant biliary strictures. This study aimed to evaluate the histological effects of balloon-RFA in porcine bile ducts. METHODS Balloon-RFA of intrahepatic bile ducts from freshly resected porcine livers was performed for 60 s at 50, 60 and 70 °C. The specimens were subsequently sectioned for histological analysis and the slides were digitally scanned. Pseudo-coloring was applied based on the intensity of the ablation effect, and the area and estimated volume of ablation were measured. RESULTS All samples showed epithelial sloughing and coagulative necrosis, and the entire internal circumference of the bile duct was evenly ablated. Complete transmural necrosis and involvement beyond the wall were found in 0% of samples ablated at 50 °C, in 33% at 60 °C and 100% at 70 °C. The mean depth and estimated volume of the ablation areas were 1.29 mm and 353.84 mm3, 1.44 mm, and 505.54 mm3 and 1.81 mm and 702.52 mm3 at 50, 60 and 70 °C, respectively. CONCLUSIONS Balloon-RFA leads to sloughing of the mucosa and coagulative necrosis. Ablation depth and volume increased in proportion to target temperature.
Collapse
Affiliation(s)
- Tadahisa Inoue
- Department of Gastroenterology, Aichi Medical University, Nagakute, Japan
| | - Masashi Yoneda
- Department of Gastroenterology, Aichi Medical University, Nagakute, Japan
| |
Collapse
|
|
21
|
Andrasina T, Rohan T, Panek J, Kovalcikova P, Kunovsky L, Ostrizkova L, Valek V. The combination of endoluminal radiofrequency ablation and metal stent implantation for the treatment of malignant biliary stenosis - Randomized study. Eur J Radiol 2021; 142:109830. [PMID: 34230002 DOI: 10.1016/j.ejrad.2021.109830] [Citation(s) in RCA: 10] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/06/2021] [Revised: 05/31/2021] [Accepted: 06/18/2021] [Indexed: 12/17/2022]
Abstract
PURPOSE To analyse whether endobiliary radiofrequency ablation prior metal stent insertion in malignant biliary stenosis show improved survival or stent patency. METHODS 76 patients with histologically proven malignant biliary stenosis have been enrolled in a prospective, randomized study. In control arm, 40 patients underwent self-expandable metal stent insertion. In experimental arm, the endoluminal ablation with a bipolar radiofrequency catheter was performed immediately before stent insertion. A subgroup analysis of cholangiocarcinoma was performed (22 vs 21 patients). The objective of the study was to determine the rate of complications, duration of the stent patency and the survival of patients (Kaplan-Meier analysis). RESULTS No major complications related to the stent insertion and the endoluminal ablation were found. The mean primary stent patency was 5.2 (95% CI 0.7-12.8) vs 4.8 months (95% CI 0.8-18.2) months (p = 0.79) in control and experimental group, respectively, in the subgroup analysis with cholangiocarcinoma 4.5 (95% CI 0.8-10.3) and 9.6 (95% CI 5.2-11.2) months (p = 0.029). The median survival since the insertion of the stent was 6.8 (95 %CI 3.0-10.6) vs 5.2 (95 %CI 2.4-7.9) months (p = 0.495) and since the initial drainage 9.8 (95 %CI 6.9-12.7) vs 9.1 (95 %CI 5.4-12.7) months (p = 0.720) in the control and experimental arm. CONCLUSION Endobiliary radiofrequency ablation prior metal stent insertion showed increased patency rate only in patients with cholangiocarcinoma, on the other hand, no improvement in survival was demonstrated in this randomized clinical study.
Collapse
Affiliation(s)
- Tomas Andrasina
- Department of Radiology and Nuclear Medicine, University Hospital Brno and Faculty of Medicine, Masaryk University, Brno 625 00, Czech Republic
| | - Tomas Rohan
- Department of Radiology and Nuclear Medicine, University Hospital Brno and Faculty of Medicine, Masaryk University, Brno 625 00, Czech Republic.
| | - Jiri Panek
- Department of Radiology and Nuclear Medicine, University Hospital Brno and Faculty of Medicine, Masaryk University, Brno 625 00, Czech Republic
| | - Petra Kovalcikova
- Institute of Biostatistics and Analyses, Masaryk University, Brno 625 00, Czech Republic
| | - Lumir Kunovsky
- Department of Surgery, University Hospital Brno and Faculty of Medicine, Masaryk University, Brno 625 00, Czech Republic; Department of Gastroenterology and Internal Medicine, University Hospital Brno and Faculty of Medicine, Masaryk University, Brno 625 00, Czech Republic
| | - Lenka Ostrizkova
- Department of Hematooncology, Oncology and Internal Medicine, University Hospital Brno and Faculty of Medicine, Masaryk University, Brno 625 00, Czech Republic
| | - Vlastimil Valek
- Department of Radiology and Nuclear Medicine, University Hospital Brno and Faculty of Medicine, Masaryk University, Brno 625 00, Czech Republic
| |
Collapse
|
|
22
|
Dorrell R, Pawa S, Pawa R. Endoscopic Management of Malignant Biliary Stricture. Diagnostics (Basel) 2020; 10:E390. [PMID: 32532018 PMCID: PMC7345676 DOI: 10.3390/diagnostics10060390] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/18/2020] [Revised: 06/04/2020] [Accepted: 06/08/2020] [Indexed: 12/17/2022] Open
Abstract
A biliary stricture is an area of narrowing in the extrahepatic or intrahepatic biliary system. The majority of biliary strictures are caused by malignancies, particularly cholangiocarcinoma and pancreatic adenocarcinoma. Most malignant biliary strictures are unresectable at diagnosis. Treatment of these diseases historically required surgical procedures, however, the development of endoscopic techniques has provided alternative minimally invasive treatment options to improve patient quality of life and survival with unresectable disease. While endoscopic retrograde cholangiopancreatography with stent placement has been the cornerstone of biliary drainage for decades, cutting edge endoscopic developments, including radiofrequency ablation and endoscopic ultrasound-guided biliary drainage, offer new therapy options to patients that historically have a poor quality of life and a grim prognosis. In this review, we explore the endoscopic techniques that have contributed to revolutionary advancements in the endoscopic management of malignant biliary strictures.
Collapse
Affiliation(s)
- Robert Dorrell
- Department of Medicine, Wake Forest School of Medicine, Winston-Salem, NC 27157, USA;
| | - Swati Pawa
- Department of Medicine, Division of Gastroenterology, Wake Forest School of Medicine, Winston-Salem, NC 27157, USA;
| | - Rishi Pawa
- Department of Medicine, Division of Gastroenterology, Wake Forest School of Medicine, Winston-Salem, NC 27157, USA;
| |
Collapse
|