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Takahashi S, Fujisawa T, Takasaki Y, Namima D, Tomishima K, Ishii S, Isayama H. Side-by-side placement of a novel slim 6-mm multi-hole covered self-expandable metallic stent for malignant hilar biliary obstruction. Endoscopy 2025; 57:E312-E313. [PMID: 40233932 PMCID: PMC12020676 DOI: 10.1055/a-2569-7582] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 04/17/2025]
Affiliation(s)
- Sho Takahashi
- Department of Gastroenterology, Jutendo University, Graduate School of Medicine, Tokyo, Japan
| | - Toshio Fujisawa
- Department of Gastroenterology, Jutendo University, Graduate School of Medicine, Tokyo, Japan
| | - Yusuke Takasaki
- Department of Gastroenterology, Jutendo University, Graduate School of Medicine, Tokyo, Japan
| | - Daisuke Namima
- Department of Gastroenterology, Jutendo University, Graduate School of Medicine, Tokyo, Japan
| | - Ko Tomishima
- Department of Gastroenterology, Jutendo University, Graduate School of Medicine, Tokyo, Japan
| | - Shigeto Ishii
- Department of Gastroenterology, Jutendo University, Graduate School of Medicine, Tokyo, Japan
| | - Hiroyuki Isayama
- Department of Gastroenterology, Jutendo University, Graduate School of Medicine, Tokyo, Japan
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Takeda T, Sasaki T, Okamoto T, Mie T, Sato Y, Maegawa Y, Hirai T, Suzuki Y, Furukawa T, Ozaka M, Sasahira N. Outcomes of multi-hole self-expandable metal stents versus fully covered self-expandable metal stents for malignant distal biliary obstruction in unresectable pancreatic cancer. DEN OPEN 2025; 5:e70014. [PMID: 39323619 PMCID: PMC11422663 DOI: 10.1002/deo2.70014] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 08/01/2024] [Revised: 08/29/2024] [Accepted: 09/05/2024] [Indexed: 09/27/2024]
Abstract
Objectives The multi-hole self-expandable metal stent (MHSEMS) is a novel SEMS with multiple small side holes on the covering membrane to prevent stent migration while minimizing tumor ingrowth. This study aimed to evaluate the clinical outcomes of MHSEMS in comparison with conventional covered SEMS (c-CMS). Methods Consecutive patients with unresectable pancreatic cancer who underwent initial SEMS placement (MHSEMS or c-CMS) for malignant distal biliary obstruction were analyzed. Technical success, clinical success, causes of recurrent biliary obstruction (RBO), non-RBO adverse events, time to RBO (TRBO), and endoscopic reintervention were compared between groups. Results A total of 65 patients were included (MHSEMS: 27, c-CMS: 38). The technical success, clinical success, and non-RBO adverse event rates were similar between groups. Although stent migration was less frequently observed in the MHSEMS group (0% vs. 17.6%, p = 0.032), overall RBO rates were similar between groups (53.8% vs. 55.9%, p > 0.99). The most common cause of RBO within 14 days in the MHSEMS group was non-occlusion cholangitis. Median TRBO was significantly shorter in the MHSEMS group (101 vs. 227 days, p = 0.030) and MHSEMS was an independent predictor for shorter TRBO in multivariate analysis (hazard ratio, 2.27; 95% confidence interval, 1.06-4.86; p = 0.034). Outcomes after endoscopic interventio were not significantly different between groups. Stent removal was successful in all attempted cases in both groups. Conclusions MHSEMS was associated with a significantly shorter TRBO compared to c-CMS. Further modifications of the present MHSEMS may be needed.
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Affiliation(s)
- Tsuyoshi Takeda
- Department of Hepato‐Biliary‐Pancreatic MedicineCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
| | - Takashi Sasaki
- Department of Hepato‐Biliary‐Pancreatic MedicineCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
| | - Takeshi Okamoto
- Department of Hepato‐Biliary‐Pancreatic MedicineCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
| | - Takafumi Mie
- Department of Hepato‐Biliary‐Pancreatic MedicineCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
| | - Yoichiro Sato
- Department of Hepato‐Biliary‐Pancreatic MedicineCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
| | - Yuri Maegawa
- Department of Hepato‐Biliary‐Pancreatic MedicineCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
| | - Tatsuki Hirai
- Department of Hepato‐Biliary‐Pancreatic MedicineCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
| | - Yukari Suzuki
- Department of Hepato‐Biliary‐Pancreatic MedicineCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
| | - Takaaki Furukawa
- Department of Hepato‐Biliary‐Pancreatic MedicineCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
| | - Masato Ozaka
- Department of Hepato‐Biliary‐Pancreatic MedicineCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
| | - Naoki Sasahira
- Department of Hepato‐Biliary‐Pancreatic MedicineCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
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Takahashi S, Takeda T, Kobayashi M, Saito K, Suda K, Yamamoto N, Mizuno S, Fukuda R, Kato H, Tomishima K, Ishii S, Fujisawa T, Hisada Y, Takahara N, Sasaki T, Kogure H, Matsubara S, Sasahira N, Nakai Y, Mochida S, Isayama H. Efficacy and safety of a novel multi-hole fully covered self-expandable metallic stent for malignant distal biliary obstruction: Multicenter retrospective study. Dig Endosc 2025. [PMID: 40084472 DOI: 10.1111/den.15006] [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: 09/11/2024] [Accepted: 01/28/2025] [Indexed: 03/16/2025]
Abstract
OBJECTIVES Covered self-expandable metallic stents (CSEMS) are effective for managing malignant distal biliary obstruction (MDBO). However, migration is a significant problem, which requires prevention. The novel multi-hole fully CSEMS (MHSEMS), which features multiple small holes on the covered membrane, is expected to prevent migration. This study aimed to evaluate the efficacy and safety of MHSEMS for MDBO. METHODS This multicenter retrospective cohort study included 111 patients with MDBO who underwent MHSEMS placement between September 2022 and August 2023. The primary outcome was the recurrent biliary obstruction (RBO) rate. The secondary outcomes were adverse event (AE) rates, removability, technical and clinical success rates, and time to RBO. RESULTS The technical success rate was 100%, and the clinical success rate was 94.6%. AEs occurred in 34.2% of patients, with RBO in 21.0% and non-RBO AEs in 17.1%. RBO included stent migration in 1.9%, stent occlusion in 11.7% (including ingrowth in 5.7%, biliary debris in 2.9%, hemobilia in 1.9%, and food impaction in 1.0%), and nonocclusion cholangitis (requiring biliary drainage) in 5.7%. Non-RBO AEs included post-endoscopic retrograde cholangiopancreatography pancreatitis in 11.7%, cholecystitis in 2.7%, and nonocclusion cholangitis in 2.7%. Stent removal was successful in 88.9% of attempts. The median time to RBO was 446 days. CONCLUSION The placement of MHSEMS for MDBO was effective and feasible, demonstrating low migration rates, acceptable AEs, and removability.
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Affiliation(s)
- Sho Takahashi
- Department of Gastroenterology, Graduate School of Medicine, Juntendo University, Tokyo, Japan
| | - Tsuyoshi Takeda
- Department of Hepato-Biliary-Pancreatic Medicine, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan
| | - Makoto Kobayashi
- Department of Gastroenterology, Yokkaichi Municipal Hospital, Mie, Japan
| | - Kei Saito
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan
| | - Kentaro Suda
- Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University, Saitama, Japan
| | - Natsuyo Yamamoto
- Department of Gastroenterology and Hepatology, National Center for Global Health and Medicine, Tokyo, Japan
| | - Suguru Mizuno
- Department of Gastroenterology and Hepatology, Faculty of Medicine, Saitama Medical University, Saitama, Japan
| | - Rintaro Fukuda
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Hiroki Kato
- Department of Gastroenterology, Yokkaichi Municipal Hospital, Mie, Japan
| | - Ko Tomishima
- Department of Gastroenterology, Graduate School of Medicine, Juntendo University, Tokyo, Japan
| | - Shigeto Ishii
- Department of Gastroenterology, Graduate School of Medicine, Juntendo University, Tokyo, Japan
| | - Toshio Fujisawa
- Department of Gastroenterology, Graduate School of Medicine, Juntendo University, Tokyo, Japan
| | - Yuya Hisada
- Department of Gastroenterology and Hepatology, National Center for Global Health and Medicine, Tokyo, Japan
| | - Naminatsu Takahara
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Takashi Sasaki
- Department of Hepato-Biliary-Pancreatic Medicine, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan
| | - Hirofumi Kogure
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan
| | - Saburo Matsubara
- Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University, Saitama, Japan
| | - Naoki Sasahira
- Department of Hepato-Biliary-Pancreatic Medicine, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan
| | - Yousuke Nakai
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
- Department of Internal Medicine, Institute of Gastroenterology, Tokyo Women's Medical University, Tokyo, Japan
| | - Satoshi Mochida
- Department of Gastroenterology and Hepatology, Faculty of Medicine, Saitama Medical University, Saitama, Japan
| | - Hiroyuki Isayama
- Department of Gastroenterology, Graduate School of Medicine, Juntendo University, Tokyo, Japan
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Lee J, Jeong S, Lee DH, Lim JH, Kobayashi M, Takenaka M, Kwon CI. Endoscopic Stenting of a Fully Covered Self-Expandable Metal Stent with a Hole in Each Cavity in Malignant Hilar Biliary Obstruction: A Preclinical Proof-of-Concept Study and Initial Human Experience. Dig Dis Sci 2025; 70:1215-1222. [PMID: 39856481 DOI: 10.1007/s10620-024-08810-1] [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: 09/16/2024] [Accepted: 12/17/2024] [Indexed: 01/27/2025]
Abstract
BACKGROUND AND AIM Stent placement for biliary drainage in patients with malignant hilar biliary obstruction (MHBO) has been a topic of long-standing debate, and the best approach remains controversial. Therefore, we aimed to evaluate the efficacy, safety, and removability of multi-hole fully covered self-expandable metal stents (MH-FCSEMSs) in a preclinical experiment using swine hilar bile duct obstruction (HBDO) models and to assess the feasibility and safety of stent placement in patients with MHBO. METHODS Three minipigs underwent endoscopic retrograde cholangiopancreatography (ERCP)-guided endobiliary-radio frequency ablation (EB-RFA) to establish Bismuth type II hilar bile duct stenosis models. Four weeks after EB-RFA, 10-mm diameter and 4-cm length MH-FCSEMSs were endoscopically inserted into the left intrahepatic bile duct of the models. Stent patency and migration, as well as adverse events including cholangitis and endoscopic stent removability, were assessed three months after stent placement. Additionally, clinical applications of MH-FCSEMS were performed in two patients with MHBO to determine feasibility, safety, and stent patency. RESULTS MH-FCSEMSs were successfully inserted into the left main intrahepatic bile duct and common hepatic duct of the models under ERCP in all three animals without any technical difficulties. Cholangiograms performed 12 weeks after MH-FCSEMS placement showed no stent migration, and all were successfully removed from the animal models. The functional success rate, defined as a decrease in serum total bilirubin level of more than 50% at 12 weeks after stent placement, was 100%. Moreover, MH-FCSEMSs were successfully inserted in two patients with hilar cholangiocarcinoma. The procedures were technically feasible, and no major periprocedural complications were noted. CONCLUSION The preliminary long-term results of both preclinical and clinical pilot studies suggest that endoscopic biliary drainage using MH-FCSEMS may be a safe and effective treatment option for stenting and stent revision in the management of HBDO. Further studies comparing clinical outcomes to those of MH-FCSEMS without multi-hole in malignant hilar biliary obstruction will be needed to verify the clinical benefits.
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Affiliation(s)
- Jungnam Lee
- Division of Gastroenterology, Department of Internal Medicine, Inha University Hospital, Inha University College of Medicine, Incheon, Republic of Korea
| | - Seok Jeong
- Division of Gastroenterology, Department of Internal Medicine, Inha University Hospital, Inha University College of Medicine, Incheon, Republic of Korea.
| | - Don Haeng Lee
- Division of Gastroenterology, Department of Internal Medicine, Inha University Hospital, Inha University College of Medicine, Incheon, Republic of Korea
- Utah-Inha DDS and Advanced Therapeutics Research Center, Incheon, Republic of Korea
| | - Jung-Hyun Lim
- Division of Gastroenterology, Department of Internal Medicine, Inha University Hospital, Inha University College of Medicine, Incheon, Republic of Korea
| | - Makoto Kobayashi
- Department of Gastroenterology, Yokkaichi Municipal Hospital, Yokkaichi, Japan
| | - Mamoru Takenaka
- Department of Gastroenterology and Hepatology, Faculty of Medicine, Kindai University, Osaka-Sayama, Japan
| | - Chang-Il Kwon
- Digestive Disease Center, Department of Internal Medicine, CHA Bundang Medical Center, CHA University, Seongnam, Republic of Korea
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Kulpatcharapong S, Piyachaturawat P, Mekaroonkamol P, Angsuwatcharakon P, Ridtitid W, Kongkam P, Rerknimitr R. Efficacy of multi-hole self-expandable metal stent compared to fully covered and uncovered self-expandable metal stents in patients with unresectable malignant distal biliary obstruction: a propensity analysis. Surg Endosc 2024; 38:212-221. [PMID: 37964091 DOI: 10.1007/s00464-023-10541-9] [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: 05/01/2023] [Accepted: 10/12/2023] [Indexed: 11/16/2023]
Abstract
BACKGROUND AND AIMS Self-expandable metal stent (SEMS) insertion is the standard palliative treatment for unresectable malignant extrahepatic biliary obstruction (MBO). Drawbacks of conventional fully covered SEMS (FCSEMS) and uncovered SEMS (USEMS) include stent migration and tumor ingrowth, respectively. This study aimed to compare stent patency in MBO with the newly design multi-hole SEMS (MHSEMS), which has multiple small side holes in the stent membrane, with conventional FCSEMS and UCSEMS. PATIENTS AND METHODS This retrospective study using a propensity score matching design and stent patency times of 40 patients with MHSEMS was compared to 40 and 34 patients with FCSEMS and UCSEMS during the same period, respectively. Secondary outcomes were procedure-related adverse events, clinical success rate, time to recurrent biliary obstruction (RBO), and etiology of RBO. RBO was compared using Kaplan-Meier analysis. RESULTS Baseline characteristics after matching were comparable among the 3 groups. RBO rates were 21%, 37%, and 55% for MHSEMS, FCSEMS, and UCSEMS, respectively (p = 0.014), at a mean time of 479, 353, and 306 days, respectively (MHSEMS vs UCSEMS, p = 0.002). Rate of tumor ingrowth was highest in the UCSEMS group (42.4% vs 13.2% in MHSEMS; p = 0.005 and vs 0% in FCSEMS; p < 0.001). Stent migration rate was highest in the FCSEMS group at 15.8% vs 2.6% in MHSEMS (p = 0.047) and 0% in UCSEMS (p = 0.005). CONCLUSION MHSEMS provided the longest stent patency time with lowest RBO rate compared to conventional SEMS by showing a lower stent migration rate than FCSEMS and a lower tumor ingrowth rate than UCSEMS.
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Affiliation(s)
- Santi Kulpatcharapong
- Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Thai Red Cross Society, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Rama 4 Road, Patumwan, Bangkok, 10330, Thailand
| | - Panida Piyachaturawat
- Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Thai Red Cross Society, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Rama 4 Road, Patumwan, Bangkok, 10330, Thailand
| | - Parit Mekaroonkamol
- Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Thai Red Cross Society, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Rama 4 Road, Patumwan, Bangkok, 10330, Thailand
| | - Phonthep Angsuwatcharakon
- Department of Anatomy, Faculty of Medicine, Thai Red Cross Society, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand
| | - Wiriyaporn Ridtitid
- Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Thai Red Cross Society, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Rama 4 Road, Patumwan, Bangkok, 10330, Thailand
| | - Pradermchai Kongkam
- Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Thai Red Cross Society, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Rama 4 Road, Patumwan, Bangkok, 10330, Thailand
| | - Rungsun Rerknimitr
- Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Thai Red Cross Society, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Rama 4 Road, Patumwan, Bangkok, 10330, Thailand.
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Inoue T, Kitano R, Ibusuki M, Sakamoto K, Kimoto S, Kobayashi Y, Sumida Y, Nakade Y, Ito K, Yoneda M. Endoscopic Ultrasound-Guided Naso-gallbladder Drainage Using a Dedicated Catheter for Acute Cholecystitis After Transpapillary Metal Stent Placement for Malignant Biliary Obstruction. Dig Dis Sci 2023; 68:4449-4455. [PMID: 37831399 DOI: 10.1007/s10620-023-08135-5] [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: 04/21/2023] [Accepted: 09/27/2023] [Indexed: 10/14/2023]
Abstract
BACKGROUND Acute cholecystitis is a significant adverse event after self-expandable metal stent (SEMS) placement for malignant biliary obstruction (MBO); however, no appropriate treatment strategy has been established for its management. AIMS This study aimed to examine the feasibility and utility of endoscopic ultrasound-guided naso-gallbladder drainage (EUS-NGBD) for the management of acute cholecystitis occurring after SEMS placement. METHODS This retrospective study investigated consecutive patients with acute cholecystitis after SEMS placement for unresectable MBO, in whom EUS-NGBD was attempted. The study outcomes included technical success, clinical success, procedure time, adverse event, and cholecystitis recurrence, associated with the procedure. RESULTS During the study period, EUS-NGBD was performed for SEMS-related acute cholecystitis in 30 patients with MBO. The technical and clinical success rates were 96.7% (29/30) and 96.6% (28/29), respectively. The median procedure time was 15 min, and rate of procedure-related adverse event was 3.3% (1/30). The median duration from the procedure to tube removal was 9 days. No adverse events were observed after removal. The median hospitalization duration after the procedure was 14 days, and the median duration to the (re-)start of chemotherapy from cholecystitis onset was 13 days. The median overall survival after EUS-NGBD was 123 days, and the rate of cholecystitis recurrence until death was 4.2% (1/28). CONCLUSIONS This study demonstrated that EUS-NGBD possesses good technical and clinical feasibility with an acceptable adverse event rates and short hospitalization and chemotherapy withdrawal period. Therefore, EUS-NGBD may be a good option for the treatment of SEMS-related cholecystitis in patients with MBO.
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Affiliation(s)
- Tadahisa Inoue
- 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
| | - Mayu Ibusuki
- Department of Gastroenterology, Aichi Medical University, 1-1 Yazakokarimata, Nagakute, Aichi, 480-1195, Japan
| | - Kazumasa Sakamoto
- Department of Gastroenterology, Aichi Medical University, 1-1 Yazakokarimata, Nagakute, Aichi, 480-1195, Japan
| | - Satoshi Kimoto
- Department of Gastroenterology, Aichi Medical University, 1-1 Yazakokarimata, Nagakute, Aichi, 480-1195, Japan
| | - Yuji Kobayashi
- Department of Gastroenterology, Aichi Medical University, 1-1 Yazakokarimata, Nagakute, Aichi, 480-1195, Japan
| | - Yoshio Sumida
- Department of Gastroenterology, Aichi Medical University, 1-1 Yazakokarimata, Nagakute, Aichi, 480-1195, Japan
| | - Yukiomi Nakade
- 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
| | - Masashi Yoneda
- Department of Gastroenterology, Aichi Medical University, 1-1 Yazakokarimata, Nagakute, Aichi, 480-1195, Japan
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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.).
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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
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Optimal reproduction of a porcine benign biliary stricture model using endobiliary radiofrequency ablation. Sci Rep 2022; 12:12046. [PMID: 35835985 PMCID: PMC9283468 DOI: 10.1038/s41598-022-16340-x] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/11/2022] [Accepted: 07/08/2022] [Indexed: 11/17/2022] Open
Abstract
The use of endobiliary radiofrequency ablation (RFA) to generate a benign biliary stricture (BBS) model has a significant reproducibility problem. The aims of this animal study were to create an optimal BBS model using endobiliary RFA and determine the best way to develop it. The first step was performed on the common bile duct (CBD) of 10 miniature pigs using endoscopic RFA with a target temperature-controlled mode (80 ℃, 7 W for 90 s). The second step was performed on the CBD of five miniature pigs to understand more about the time-dependent changes in BBS development and the causes of adverse events. Using the conditions and techniques identified in the previous steps, the third step was conducted to create an optimal BBS model in 12 miniature pigs. In the first trial, four out of 10 animals died (40%) after the procedure due to cholangitis-induced sepsis. Based on this, biliary obstruction was prevented in further steps by placing a biliary plastic stent after RFA application. Histologic examinations over time showed that a severe abscess developed at the RFA application site on the fifth day, followed by fibrosis on the tenth day, and completion on the twentieth day. In the third trial, 11 animals survived (91.7%), the average BBS fibrotic wall thickness was 1107.9 µm (763.1–1864.6 µm), and the degree of upstream biliary dilation was 14.4 mm (11.05–20.7 mm). In conclusion, endobiliary RFA combined with a biliary plastic stent resulted in a safe and reproducible BBS animal model.
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9
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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: 31] [Impact Index Per Article: 10.3] [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.
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Affiliation(s)
- Tadahisa Inoue
- Department of Gastroenterology, Aichi Medical University, Aichi, Japan
| | - Masashi Yoneda
- Department of Gastroenterology, Aichi Medical University, Aichi, Japan
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Jeong S, Park JS, Lee DH. [Large Animal Models in Pancreas and Biliary Disease]. THE KOREAN JOURNAL OF GASTROENTEROLOGY 2021; 77:99-103. [PMID: 33758107 DOI: 10.4166/kjg.2021.031] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 02/19/2021] [Accepted: 03/12/2021] [Indexed: 11/03/2022]
Abstract
Rodent models, which have played important roles in preclinical research of pancreas and biliary diseases, have some limitations to translating data from rodent models to human diseases. Large animal models have recently been developed to overcome these limitations and perform translational research of medical devices and drugs in pancreas and biliary diseases. Preclinical studies using large animal models are necessary before clinical application, especially for the research and development of equipment, instrumentation, and techniques in pancreato-biliary diseases. As long as the endoscope used in humans can enter an organ, there appears to be no limitation in terms of species or organ for endoscopic experiments of large animal models. Investigators have mainly used swine for pancreas and biliary endoscopic experiments. Until now, unique swine models that investigators have been established include the normal bile duct model, bile duct dilation model, bile duct dilation+direct peroral cholangioscopy model, benign biliary stricture model, hilar biliary obstruction model, and acute pancreatitis (post-ERCP pancreatitis) model. Many preclinical studies have been performed using these established endoscopy-based large animal models to develop novel medical devices. Furthermore, porcine pancreatic cancer models induced by a transgenic or orthotopic method are currently under development. These models appear to be available for general use in the future and will have multiple potential preclinical and clinical applications.
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Affiliation(s)
- Seok Jeong
- Department of Internal Medicine, Inha University College of Medicine, Incheon, Korea
| | - Jin-Seok Park
- Department of Internal Medicine, Inha University College of Medicine, Incheon, Korea
| | - Don Haeng Lee
- Department of Internal Medicine, Inha University College of Medicine, Incheon, Korea
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Abstract
The evolution of advanced pancreaticobiliary endoscopy in the past 50 years is remarkable. Endoscopic retrograde cholangiopancreatography (ERCP) has progressed from a diagnostic test to an almost entirely therapeutic procedure. The endoscopist must have a clear understanding of the indications for ERCP to avoid unnecessary complications, including post-ERCP pancreatitis. Endoscopic ultrasound initially was used as a diagnostic tool but now is equipped with accessary channels allowing endoscopic ultrasound-guided interventions in various pancreaticobiliary conditions. This review discusses the endoscopic management of common pancreatic and biliary diseases along with the techniques, indications, outcomes, and complications of pancreaticobiliary endoscopy.
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Affiliation(s)
- Catherine F Vozzo
- Department of Gastroenterology, Cleveland Clinic, 9500 Euclid Avenue / A30, Cleveland, OH 44195, USA
| | - Madhusudhan R Sanaka
- Department of Gastroenterology, Cleveland Clinic, 9500 Euclid Avenue / Q30, Cleveland, OH 44195, USA.
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Kobayashi M. Development of a biliary multi-hole self-expandable metallic stent for bile tract diseases: A case report. World J Clin Cases 2019; 7:1323-1329. [PMID: 31236396 PMCID: PMC6580344 DOI: 10.12998/wjcc.v7.i11.1323] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/30/2018] [Revised: 04/20/2019] [Accepted: 05/11/2019] [Indexed: 02/05/2023] Open
Abstract
BACKGROUND Uncovered stents used for malignant obstructions in the biliary tree, especially in the hilar area, are prone to obstruction by tumor ingrowths. In comparison, however, covered stents may block bile duct branches and are at risk of migration. We have developed a multi-hole self-expandable metallic stent (MHSEMS), with a hole in each cell, to prevent the obstruction of bile duct branches. In addition, the holes may prevent migration due to small ingrowths by reducing the tension of the membrane.
CASE SUMMARY MHSEMS were placed in five patients with a malignant obstruction and one with post-endoscopic sphincterotomy bleeding. Each MHSEMS was successfully deployed in all cases. Patients showed no complications. Two cases were reviewed. Case 1: A 74-year-old male presented with jaundice and was diagnosed with a sigmoid colon cancer and giant liver metastases in the right liver lobe. A MHSEMS was placed in the left bile duct. The jaundice improved and peroral cholangioscopy was performed. Case 2: A 90-year-old female was admitted to hospital for jaundice and diagnosed with cholangiocarcinoma. A MHSEMS was placed in the left bile duct but after 8 months the stent became obstructed by tumor ingrowth. We treated the patient by ablation therapy. A silicone cover separated the internal bile duct from the surrounding tissue, protecting the latter from thermal injury during treatment by endobiliary ablation of the re-obstruction.
CONCLUSION A MHSEMS is a new choice of stent for biliary tract diseases.
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Affiliation(s)
- Makoto Kobayashi
- Division of Gastroenterology, Yokkaichi Municipal Hospital, Yokkaichi, Mie 5108657, Japan
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