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Truong VG, Kim H, Lee BI, Cha B, Jeong S, Oh SJ, Kang HW. Development of Novel Balloon-Integrated Optical Catheter for Endoscopic and Circumferential Laser Application. Ann Biomed Eng 2023; 51:2021-2034. [PMID: 37191825 DOI: 10.1007/s10439-023-03228-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/06/2023] [Accepted: 04/29/2023] [Indexed: 05/17/2023]
Abstract
The current study aims to demonstrate the feasibility of a novel balloon-integrated optical catheter (BIOC) to achieve endoscopic laser application for circumferential coagulation of a tubular tissue structure. Both optical and thermal numerical simulations were developed to predict the propagation of laser light and a spatio-temporal distribution of temperature in tissue. Ex vivo esophagus tissue was tested with 980 nm laser light at 30 W for 90 s for quantitative evaluations. In vivo porcine models were used to validate the performance of BIOC for circumferential and endoscopic laser coagulation of esophagus in terms of acute tissue responses post-irradiation. Optical simulations confirmed that a diffusing applicator was able to generate a circumferential light distribution in a tubular tissue structure. Both numerical and experimental results presented that the maximum temperature elevation occurred at 3-5 mm (muscle layer) below the mucosa surface after 90 s irradiation. In vivo tests confirmed the circumferential delivery of laser light to a deep muscle layer as well as no evidence of thermal damage to the esophageal mucosa. The proposed BIOC can be a feasible optical device to provide circumferential laser irradiation as well as endoscopic coagulation of tubular esophagus tissue for clinical applications.
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Affiliation(s)
- Van Gia Truong
- Industry 4.0 Convergence Bionics Engineering and Marine-Integrated Biomedical Technology Center, Pukyong National University, Busan, Republic of Korea
- TeCure, Inc., Busan, Republic of Korea
| | - Hyejin Kim
- Industry 4.0 Convergence Bionics Engineering and Marine-Integrated Biomedical Technology Center, Pukyong National University, Busan, Republic of Korea
- TeCure, Inc., Busan, Republic of Korea
| | - Byeong-Il Lee
- Division of Smart Healthcare, College of Information Technology and Convergence, Pukyong National University, Busan, Republic of Korea
| | - Boram Cha
- Department of Internal Medicine, Inha University School of Medicine, Inha University Hospital, Incheon, Republic of Korea
| | - Seok Jeong
- Department of Internal Medicine, Inha University School of Medicine, Inha University Hospital, Incheon, Republic of Korea
| | - Sun-Ju Oh
- Department of Pathology, Kosin University College of Medicine, Busan, Republic of Korea
| | - Hyun Wook Kang
- Industry 4.0 Convergence Bionics Engineering and Marine-Integrated Biomedical Technology Center, Pukyong National University, Busan, Republic of Korea.
- TeCure, Inc., Busan, Republic of Korea.
- Division of Smart Healthcare, College of Information Technology and Convergence, Pukyong National University, Busan, Republic of Korea.
- Marine-Integrated Biomedical Technology Center, The National Key Research Institutes in Universities, Pukyong National University, Busan, Republic of Korea.
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Ota K, Takeuchi T, Higuchi K, Sasaki S, Mori Y, Tanaka H, Hakoda A, Sugawara N, Iwatsubo T, Nishikawa H. Frontiers in Endoscopic Treatment for Gastroesophageal Reflux Disease. Digestion 2023; 105:5-10. [PMID: 37591209 DOI: 10.1159/000533200] [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: 04/01/2023] [Accepted: 07/05/2023] [Indexed: 08/19/2023]
Abstract
BACKGROUND The 3rd edition of the evidence-based clinical practice guidelines for gastroesophageal reflux disease (GERD) 2021 from the Japanese Society of Gastroenterology states that the treatment strategy for potassium-competitive acid blocker (PCAB)-refractory GERD remains unclear. Furthermore, even if GERD improves with the administration of an acid secretion inhibitor, it is feared that GERD may flare up after discontinuation of the drug, resulting in some cases in which patients are forced to take vonoprazan semipermanently (the so-called PCAB-dependent cases). From a global perspective, PCAB is not yet used in all countries and regions, and measures that can be taken now for cases in which a conventional proton pump inhibitor (PPI) is inadequately effective need to be devised. SUMMARY Endoscopic treatment for GERD may be effective in cases where conventional proton pump inhibitors are ineffective; however, there are insufficient long-term studies to corroborate this, and its cost effectiveness is unknown. Other treatment options for PCAB or PPI-refractory GERD include surgical procedures (Nissen and Toupet operations), which have a longer history than endoscopic treatment for GERD. However, their long-term results are not as good as those of acid secretion inhibitors, and they are not cost effective. Endoscopic treatment for GERD may fill gaps in inadequate surgical treatment. In April 2022, endoscopic anti-reflux mucosal resections (ARMS [anti-reflux mucosectomy] and ESD-G [endoscopic submucosal dissection for GERD]) were approved for reimbursement, making endoscopic treatment of GERD possible throughout Japan. KEY MESSAGES It is important to identify the background factors in cases in which endoscopic treatments are effective.
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Affiliation(s)
- Kazuhiro Ota
- Second Department of Internal Medicine, Osaka Medical and Pharmaceutical University, Takatsuki, Japan
| | - Toshihisa Takeuchi
- Second Department of Internal Medicine, Osaka Medical and Pharmaceutical University, Takatsuki, Japan
| | - Kazuhide Higuchi
- Second Department of Internal Medicine, Osaka Medical and Pharmaceutical University, Takatsuki, Japan
| | - Shun Sasaki
- Second Department of Internal Medicine, Osaka Medical and Pharmaceutical University, Takatsuki, Japan
| | - Yosuke Mori
- Second Department of Internal Medicine, Osaka Medical and Pharmaceutical University, Takatsuki, Japan
| | - Hironori Tanaka
- Second Department of Internal Medicine, Osaka Medical and Pharmaceutical University, Takatsuki, Japan
| | - Akitoshi Hakoda
- Second Department of Internal Medicine, Osaka Medical and Pharmaceutical University, Takatsuki, Japan
| | - Noriaki Sugawara
- Second Department of Internal Medicine, Osaka Medical and Pharmaceutical University, Takatsuki, Japan
| | - Taro Iwatsubo
- Second Department of Internal Medicine, Osaka Medical and Pharmaceutical University, Takatsuki, Japan
| | - Hiroki Nishikawa
- Second Department of Internal Medicine, Osaka Medical and Pharmaceutical University, Takatsuki, Japan
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Endoscopic radiofrequency versus a sham procedure for treatment of gastroesophageal reflux disease. EGYPTIAN LIVER JOURNAL 2011. [DOI: 10.1097/01.elx.0000397026.33294.5f] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/27/2022] Open
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Richter JE, Friedenberg FK. Gastroesophageal Reflux Disease. SLEISENGER AND FORDTRAN'S GASTROINTESTINAL AND LIVER DISEASE 2010:705-726.e6. [DOI: 10.1016/b978-1-4160-6189-2.00043-3] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/04/2025]
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The Stretta procedure versus proton pump inhibitors and laparoscopic Nissen fundoplication in the management of gastroesophageal reflux disease: a cost-effectiveness analysis. CANADIAN JOURNAL OF GASTROENTEROLOGY = JOURNAL CANADIEN DE GASTROENTEROLOGIE 2008; 22:552-8. [PMID: 18560633 DOI: 10.1155/2008/765458] [Citation(s) in RCA: 27] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/17/2022]
Abstract
BACKGROUND The Stretta procedure is an endoscopic therapy for gastroesophageal reflux disease. OBJECTIVE To evaluate the cost-effectiveness of the Stretta procedure and that of competing strategies in the long-term management of gastroesophageal reflux disease. METHODS A Markov model was designed to estimate costs and health outcomes in Canadian patients with gastroesophageal reflux disease over five years, from a Ministry of Health perspective. Strategies included the use of daily proton pump inhibitors (PPIs), laparoscopic Nissen fundoplication (LNF) and the Stretta procedure. Probabilities and utilities were derived from the literature. Costs are expressed in 2006 Canadian dollars. Units of effectiveness were symptom-free months (SFMs) and quality-adjusted life years (QALYs), using a five-year time horizon. RESULTS In the analysis that used SFMs, the strategy using PPIs exhibited the lowest costs ($40 per SFM) and the greatest number of SFMs, thus dominating both the LNF and Stretta systems. But the cost-effectiveness analysis using QALYs as the measure of effectiveness showed that PPIs presented the lowest cost-effectiveness ratio, while both the LNF and Stretta strategies were associated with very high incremental costs (approximately $353,000 and $393,000, respectively) to achieve an additional QALY. However, the PPI strategy did not dominate the two other strategies, which were associated with better effectiveness. CONCLUSIONS If SFMs are used as the measure of effectiveness, PPIs dominate the Stretta and LNF strategies. However, if QALYs are used, the PPIs still present the lowest cost and LNF gives the best effectiveness. Regardless of the units of effectiveness or utility used in the present cost analysis, an approach of prescribing PPIs appears to be the preferred strategy.
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Abstract
Approximately 20% of patients with gastroesophageal reflux disease (GERD) have symptoms refractory to long-term proton pump inhibitor (PPI) therapy. Furthermore, PPI therapy is expensive. Fundoplication is considered the gold standard of GERD therapy in terms of normalization of esophageal acid exposure and symptom control; however, this exposes the patient to the risks of surgery and anesthesia. Therefore, an endoscopic approach to treating GERD that obviates the need for PPIs and avoids surgical morbidity is desirable. Several endoscopic methods have been used, including radiofrequency ablation, implantation of foreign substances as bulking agents, and various tissue apposition strategies. The emerging field of GERD endotherapy is promising, but more rigorous, sham-controlled, long-term studies are required to elucidate its exact role in clinical practice. This review discusses the evolution of these concepts, describes specific endoscopic devices that have been developed, and explores the future of endotherapies as viable treatment alternatives for GERD.
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Affiliation(s)
- Marvin Ryou
- Brigham & Women's Hospital, Division of Gastroenterology, Harvard Medical School, 75 Francis Street, Boston, MA 02115, USA
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Anvari M. Endoscopic treatments for gastro-oesophageal reflux disease. Lancet 2008; 371:965-6. [PMID: 18358911 DOI: 10.1016/s0140-6736(08)60430-4] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 10/22/2022]
Affiliation(s)
- Mehran Anvari
- St Joseph's Healthcare, Hamilton ON, Canada L8N 4A6.
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Pace F, Costamagna G, Penagini R, Repici A, Annese V. Review article: endoscopic antireflux procedures - an unfulfilled promise? Aliment Pharmacol Ther 2008; 27:375-384. [PMID: 18162082 DOI: 10.1111/j.1365-2036.2007.03593.x] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/12/2022]
Abstract
BACKGROUND Most published reviews concerning the endoscopic treatment of gastro-oesophageal reflux disease date back to 2005. AIM To provide an updated review that includes all papers published up to 2007. METHODS A Medline search from January 2005 to June 2007 was performed regarding endoscopic procedures aiming at treating gastro-oesophageal reflux disease. In addition, we retrieved the abstracts presented at Digestive Disease Week during the last 3 years. We included in the review both 'mechanistic' studies - that is, papers exploring the potential mechanism of action of the procedure/device - and studies trying to assess its clinical efficacy. RESULTS During the last 3 years, the number of published papers has declined, and some devices are not available any more. The alleged mechanism(s) of action of the various devices or procedures is (are) still not completely elucidated; however, some concerns have arisen as far as durability and potential detrimental effects. Moreover, all the aspects of endoscopic therapy, except for its safety, are either insufficiently explored or not investigated at all, or assessed only in particularly selected patient subgroups. CONCLUSIONS None of the proposed antireflux therapies has fulfilled the criteria of efficacy, safety, cost, durability and, possibly, of reversibility. There is at present no definite indication for endoscopic therapy of gastro-oesophageal reflux disease. We suggest a list of recommendations to be followed when a new endoscopic therapeutic procedure is to be assessed for use in clinical practice.
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Affiliation(s)
- F Pace
- U.O. e Cattedra di Gastroenterologia, Ospedale Universitario L. Sacco, Milan, Italy.
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Esophagus Benign Diseases of the Esophagus. Surgery 2008. [DOI: 10.1007/978-0-387-68113-9_44] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/20/2022]
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Systematic review: endoluminal therapy for gastro-oesophageal reflux disease: evidence from clinical trials. Eur J Gastroenterol Hepatol 2007; 19:1125-39. [PMID: 17998840 DOI: 10.1097/meg.0b013e3282f16a21] [Citation(s) in RCA: 28] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/30/2022]
Abstract
During the last few decades many endoscopic interventions have been developed as an alternative for the treatment of gastro-oesophageal reflux disease (GORD). In many countries, these interventions are thus being performed in the general clinical setting. The aim of this study is to systematically review the evidence on the effect of endoscopic therapies for GORD. A systematic search of the literature on this subject in English, indexed in MEDLINE (1966 to May 2007) and in the Cochrane Library, was carried out. For the study selection, retrospective and prospective open-label and randomized, sham-controlled trials were taken into account. The exclusion criteria included the following: case series that included fewer than 10 patients, abstracts, studies involving children or those with a follow-up shorter than 3 months. For data extraction, two reviewers, using standardized forms, independently abstracted data on study design and methods, population, sample size, function studies (e.g. pH-metry), type of endoscopic treatment, follow-up, health-related and quality of life scores, outcomes and complications. Data synthesis involved the following: 43 studies, including four randomized, sham-controlled trials that met the inclusion criteria, out of 4182 citations. The primary end point in most studies was the reduction of the use of proton pump inhibitors (PPIs) by more than 50%. In view of these findings, the majority of studies suggested the efficacy of endoluminal therapies for the control of symptoms in GORD. In the sham-controlled studies, the effect of placebo was, nevertheless, as high as 50%. Most studies were small feasibility studies, with follow-ups of less than 1 year. No study comparing endoscopic techniques with other established treatment options such as PPIs existed. All endoscopic therapies were associated with a small but important percentage of mild to severe complications, which included perforation, abscess and death. In conclusion, the data from most of the short-term follow-up and the few sham-controlled studies demonstrate that subgroups of patients experienced improvement or resolution of typical GORD symptoms and decreased PPI usage. Currently, however, there are not enough scientific and clinical data on safety, efficacy and durability to support the use of endoluminal therapies for GORD in routine clinical practice.
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Falk GW, Fennerty MB, Rothstein RI. AGA Institute technical review on the use of endoscopic therapy for gastroesophageal reflux disease. Gastroenterology 2006; 131:1315-36. [PMID: 17030199 DOI: 10.1053/j.gastro.2006.08.019] [Citation(s) in RCA: 47] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/22/2022]
Affiliation(s)
- Gary W Falk
- Department of Gastroenterology and Hepatology, Center for Swallowing and Esophageal Disorders, Cleveland Clinic, Cleveland, OH, USA
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Iqbal A, Salinas V, Filipi CJ. Endoscopic therapies of gastroesophageal reflux disease. World J Gastroenterol 2006; 12:2641-55. [PMID: 16718747 PMCID: PMC4130969 DOI: 10.3748/wjg.v12.i17.2641] [Citation(s) in RCA: 18] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/08/2005] [Revised: 08/13/2006] [Accepted: 08/30/2005] [Indexed: 02/06/2023] Open
Abstract
The high prevalence of gastroesophageal reflux disease (GERD) in Western societies has accelerated the need for new modalities of treatment. Currently, medical and surgical therapies are widely accepted among patients and physicians. New potent antisecretory drugs and the development of minimally invasive surgery for the management of GERD are at present the pivotal and largely accepted approaches to treatment. The minimally invasive treatment revolution, however, has stimulated several new endoscopic techniques for GERD. Up to now, the data is limited and further studies are necessary to compare the advantages and disadvantages of the various endoscopic techniques to medical and laparoscopic management of GERD. New journal articles and abstracts are continuously being published. The Food and Drug Administration has approved 3 modalities, thus gastroenterologists and surgeons are beginning to apply these techniques. Further trials and device refinements will assist clinicians. This article will present an overview of the various techniques that are currently on study. This review will report the efficacy and durability of various endoscopic therapies for gastroesophageal reflux disease (GERD). The potential for widespread use of these techniques will also be discussed. Articles and abstracts published in English on this topic were retrieved from Pubmed. Due to limited number of studies and remarkable differences between various trials, strict criteria were not used for the pooled data presented, however, an effort was made to avoid bias by including only studies that used off-PPI scoring as baseline and intent to treat.
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Affiliation(s)
- Atif Iqbal
- Department of Surgery, University of Missouri Columbia, One Hospital Drive, 65211, USA
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Stark ME, Devault KR. Complications Following Fundoplication. TECHNIQUES IN GASTROINTESTINAL ENDOSCOPY 2006. [DOI: 10.1016/j.tgie.2006.03.001] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 12/17/2022]
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Chen YK. Endoscopic approaches to the treatment of gastroesophageal reflux disease. Curr Opin Gastroenterol 2005; 21:595-600. [PMID: 16093776 DOI: 10.1097/01.mog.0000174224.82406.aa] [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] [Indexed: 12/10/2022]
Abstract
PURPOSE OF REVIEW Endoscopic therapies for gastroesophageal reflux disease represent a minimally invasive alternative to medical or surgical treatment. These devices include suturing, radiofrequency energy, and bulking agent technologies. Research into the use of these technologies in gastroesophageal reflux disease continues to accelerate, and the last 2 years have witnessed significant developments that may affect current and future clinical practice. RECENT FINDINGS Long-term data from nonrandomized clinical trials have become available in the last 2 years for many gastroesophageal reflux disease endotherapies, providing some insight into their durability. Furthermore, two multicenter and one single-center sham-controlled trials were published recently, allowing comparison between groups. SUMMARY Although it is premature to propose the superiority of any individual approach, emerging data in this rapidly evolving field may inform current and future directions in the research and treatment of gastroesophageal reflux disease.
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Affiliation(s)
- Yang K Chen
- University of Colorado Hospital, Denver, Colorado, USA.
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Lee TJ, Kahrilas PJ. Endoluminal therapy for gastroesophageal reflux disease: is the evidence for efficacy any stronger? Curr Gastroenterol Rep 2005; 7:202-6. [PMID: 15913479 DOI: 10.1007/s11894-005-0035-8] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 05/02/2023]
Abstract
Gastroesophageal reflux disease is a common disorder often requiring chronic treatment. Joining the conventional options of antisecretory medications and fundoplication, endoluminal therapies have emerged in recent years. These techniques have entered US and European markets, claiming effectiveness comparable with antireflux surgery. Nevertheless, a paucity of data is available to support that efficacy, even as more devices are coming onto the market. This review examines published reports of endoluminal reflux therapies from January 2004 to January 2005. After another year, there are still no compelling data supporting the efficacy of any of the available endoluminal treatments.
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Affiliation(s)
- Thomas J Lee
- Feinberg School of Medicine, Division of Gastroenterology, Department of Medicine, Northwestern University, Chicago, IL 60611, USA
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Cipolletta L, Rotondano G, Dughera L, Repici A, Bianco MA, De Angelis C, Vingiani AM, Battaglia E. Delivery of radiofrequency energy to the gastroesophageal junction (Stretta procedure) for the treatment of gastroesophageal reflux disease. Surg Endosc 2005; 19:849-53. [PMID: 15868272 DOI: 10.1007/s00464-004-2169-4] [Citation(s) in RCA: 25] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/07/2004] [Accepted: 12/15/2004] [Indexed: 12/13/2022]
Abstract
BACKGROUND Radiofrequency (RF) energy treatment is increasingly offered before invasive surgical procedures for selected patients with gastroesophageal reflux disease (GERD). METHODS Thirty-two patients undergoing the Stretta procedure were prospectively evaluated with upper endoscopy, manometry, 24-hour pH testing, SF-36 surveys, and GERD-specific questionnaires (GERD HRQL). RESULTS Significant clinical improvement was observed in 91% of patients (29/32). Mean heartburn and GERD HRQL scores decreased (p = 0.001 and p = 0.003, respectively), and physical SF-36 increased (p = 0.05). At a minimum follow-up of 12 months, median esophageal acid exposure decreased (p = 0.79) and was normalized in eight patients. Median lower esophageal sphincter (LES) pressure was unchanged. Esophagitis healed in six of eight patients, but two patients with nonerosive disease developed asymptomatic grade A esophagitis during follow-up. At 12 months, 56% of patients were off proton pump inhibits. Morbidity was minimal. CONCLUSIONS RF delivery to LES is safe and significantly improves symptoms and quality of life in selected GERD patients.
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Affiliation(s)
- L Cipolletta
- Division of Gastroenterology and Digestive Endoscopy, ASLNA5 Hospital Maresca, Torre del Greco, Italy.
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Johnson DA. Evaluation of esophageal function/pH in endoscopic therapy for gastroesophageal reflux disease. Gastrointest Endosc Clin N Am 2005; 15:333-345. [PMID: 15722245 DOI: 10.1016/j.giec.2004.10.012] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/04/2023]
Abstract
Gastroesophageal reflux disease (GERD) typically requires lifelong medical therapy or surgery for the management of patients with frequent symptoms. The current standard of care is to prescribe medical therapy using proton pump inhibitors. Patients with moderate-to-severe GERD require extended/maintenance therapy. Until recently, the only alternative to this approach was surgical intervention. Endoscopic therapy for GERD has emerged as a second alternative strategy. Primary endpoints for all interventions have aimed at symptomatic control and reduction/discontinuance of medication use. For surgical and endoscopic therapies, however, there are other physiologic endpoints that have attempted to define changes in lower esophageal sphincter pressure and esophageal acid exposure. For patients being evaluated for endoscopic GERD therapy, the author recommends comprehensive esophageal testing and pH testing.
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Affiliation(s)
- David A Johnson
- Department of Gastroenterology, Eastern Virginia School of Medicine, 700 W. Olney Road, Norfolk, VA 23501, USA.
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Abstract
Guidelines for the diagnosis and treatment of gastroesophageal reflux disease (GERD) were published in 1995 and updated in 1999. These and other guidelines undergo periodic review. Advances continue to be made in the area of GERD, leading us to review and revise previous guideline statements. GERD is defined as symptoms or mucosal damage produced by the abnormal reflux of gastric contents into the esophagus. These guidelines were developed under the auspices of the American College of Gastroenterology and its Practice Parameters Committee, and approved by the Board of Trustees. Diagnostic guidelines address empiric therapy and the use of endoscopy, ambulatory reflux monitoring, and esophageal manometry in GERD. Treatment guidelines address the role of lifestyle changes, patient directed (OTC) therapy, acid suppression, promotility therapy, maintenance therapy, antireflux surgery, and endoscopic therapy in GERD. Finally, there is a discussion of the rare patient with refractory GERD and a list of areas in need of additional study.
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Affiliation(s)
- Kenneth R DeVault
- Department of Medicine, Mayo Clinic College of Medicine, Jacksonville, FL, USA
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Triadafilopoulos G. Changes in GERD symptom scores correlate with improvement in esophageal acid exposure after the Stretta procedure. Surg Endosc 2004; 18:1038-44. [PMID: 15156392 DOI: 10.1007/s00464-003-8243-5] [Citation(s) in RCA: 33] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/22/2004] [Accepted: 02/15/2004] [Indexed: 10/26/2022]
Abstract
BACKGROUND Endoscopic radiofrequency energy delivery (Stretta) is effective for managing gastroesophageal reflux disease (GERD) in selected patients. One criticism, however, is a theory that a mechanism of action is partial desensitization of the esophageal body rather than a reduction in esophageal acid exposure. To resolve this question, this study sought to determine if there is a correlation between the improvement in GERD outcomes and esophageal acid exposure after Stretta. METHODS Subgroup analyses were performed between "responder" and "nonresponder" groups from the U.S. Stretta open label trial ( n = 118), on the basis of posttreatment responses for GERD health-related quality of life (HRQL) heartburn, satisfaction, and proton pump inhibitor use. Outcomes were analyzed within and between subgroups. Pearson correlation coefficient analysis was performed comparing distal esophageal acid exposure with each of the continuous outcomes (GERD-HRQL, heartburn, satisfaction). RESULTS Responder subgroups had significant improvements in esophageal acid exposure, whereas nonresponders had no change or less improvement in the same. Changes in GERD-HRQL and heartburn severity were correlated with changes in acid exposure ( r = 0.16, p = 0.12 and r = 0.26, p = 0.01, respectively). Changes in satisfaction were negatively correlated with changes in esophageal acid exposure ( r = 0.23, p = 0.02) because satisfaction, as expected, increased as acid exposure decreased. CONCLUSIONS Responders had significant improvement in esophageal acid exposure, whereas nonresponders had less or no change. There was a positive correlation between esophageal acid exposure and both GERD-HRQL and heartburn. This evidence suggests that symptomatic improvement after Stretta is attributable to a decrease in esophageal acid exposure and not to desensitization of the esophagus.
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Affiliation(s)
- G Triadafilopoulos
- Gastroenterology Section, Veterans Affairs Palo Alto Health Care System, and the Division of Gastroenterology and Hepatology, Stanford University School of Medicine, 3801 Miranda Avenue, Palo Alto, Stanford CA 94304, USA.
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Affiliation(s)
- Steven A Edmundowicz
- Division of Gastroenterology, Washington University School of Medicine, St. Louis, Missouri 63110, USA
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Abstract
Gastro-oesophageal reflux disease represents an extremely common disorder which has a substantial impact on patients' quality of life and use of health care resources. Gastro-oesophageal reflux disease is a chronic relapsing disease for which a lifelong solution is needed. Until now the two competing therapeutic modalities have been the medical and surgical therapies. Quite recently a third option has become available. A number of endoscopic anti-reflux procedures have been described, with the common goal of creating an anti-reflux barrier, thus obviating long-term proton pump inhibitors and the cost and potential risk of laparoscopic Nissen fundoplication. In this review the different techniques are thoroughly examined and the results are critically evaluated, giving special emphasis to efficacy, safety and durability of these new anti-reflux procedures. Available data show that these anti-reflux techniques produce significant improvement in gastro-oesophageal reflux disease symptomatology and quality of life as well as reduce the use of anti-reflux medication, without causing serious morbidity or mortality. However, the majority of these techniques have failed to adequately control oesophageal acid reflux. Endoscopic anti-reflux therapies therefore sound very attractive-being less invasive than surgery-and show a significant promise, but are still in the early stages of assessment. Large-scale randomized multi-centre trials comparing control groups with sham procedures are essential to confirm their efficacy. Further studies are also necessary to determine what modifications these techniques require in order to produce maximum clinical efficacy and durability. However, considering that current therapies (both medical and surgical) of gastro-oesophageal reflux disease are highly effective, the need for such new endoscopic modalities may be questionable. Moreover, appropriate trials in dedicated centres should be carried out to assure that the enthusiasm commonly associated with new technology is justified and can be generalized to open-access endoscopists.
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Affiliation(s)
- S Contini
- Department of Surgery, School of Medicine and Dentistry, University of Parma, Parma, Italy.
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