Evaluation of effects of a novel endoscopically applied radiofrequency ablation biliary catheter using an ex‐vivo pig liver

Itoi, Takao; Isayama, Hiroyuki; Sofuni, Atsushi; Itokawa, Fumihide; Tamura, Miho; Watanabe, Yusuke; Moriyasu, Fuminori; Kahaleh, Michel; Habib, Nagy; Nagao, Toshitaka; Yokoyama, Tomohisa; Kasuya, Kazuhiko; Kawakami, Hiroshi

doi:10.1007/s00534-011-0465-7

Cited by 68 publications

(46 citation statements)

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“…[7] It is possible that similar mediators and pathways may account for the differences in survival noted in our analysis, though this is pure speculation as our retrospective study was not intended or designed to address this. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 trialled in one small phase I study in patients with pancreatic carcinoma, and its role in the management of this condition remains undefined.…”

Section: Discussionmentioning

confidence: 95%

Analysis of Endoscopic Radiofrequency Ablation of Biliary Malignant Strictures in Pancreatic Cancer Suggests Potential Survival Benefit

et al. 2015

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Abstract:Background: Pancreatic carcinoma is often inoperable, carries a poor prognosis and is commonly complicated by malignant biliary obstruction. Phase I/II studies have demonstrated good safety and early stent patency using endoscopic biliary radiofrequency ablation (RFA) as an adjunct to self-expanding metal stent (SEMS) insertion for biliary decompression. Aim: To analyse the clinical efficacy of endobiliary RFA. Methods: Retrospective case-control analysis of 23 patients with surgically unresectable pancreatic carcinoma and malignant biliary obstruction undergoing endoscopic RFA and SEMS insertion, and 46 controls (SEMS insertion alone) in a single tertiary care centre. Controls were stringently matched for age, sex, metastases, ASA/co-morbidities. Survival, morbidity, and stent patency rates were assessed. Thank you for considering our manuscript and for the helpful reviews.Please find enclosed a revised version of the manuscript for reconsideration, together with a detailed point by point response to the reviewer comments.We have taken independent statistical advice on the manuscript as suggested. RESPONSES TO REVIEWER COMMENTSReviewer #1: The authors present a retrospective series of 23 pts with unresectable panc ca treated with RFA and uncovered SEMS vs. 46 with uncovered alone and matched for chemo, mets, ASA, etc. It it novel data but the main premise for RFA is that it induces a coagulative necrosis -how it improves survival if it doesn't improve stent patency is not hypothesized. Stent patency was similar between the twogroups. Are the authors suggesting that RFA may be able to reduce tumor burden? Several comments to help the authors improve the submission. I do feel that the manuscript would benefit from more clarity and defined goals for its work. What are the primary and secondary endpoints for the study. These should be clearly stated in the Methods.The primary and secondary endpoints of the study are survival and stent patency/procedure safety, respectively. This has been highlighted in the methods section (cf point 13, below). Please see the response to point 14 below, re putative beneficial effects of RFA on patients with pancreatic cancer.Other comments: 1) Those patients who underwent chemo was higher in the RFA group (70% vs. 52%) but not statistically sig't. This may be a Type 2 error given the small sample size and this limitation should be clearly highlighted in the discussion. In fact, this seems to be the most plausible explanation as to the survival benefit in the RFA group unless the authors can provide other possible hypothesis.The possibility of a type 2 error is now mentioned in the relevant discussion section.2) The improved median survival of 226D vs. 124D has a CI that goes through 1. Please explain the limitations of this analysis and include in the discussion.The upper limit of the 95% CI is 1.06. This is represented in the fact that the two survival curves on Kaplan-Meier analysis cross at late time points, when the number of surviving patients is small. Our statistica...

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Section: Discussionmentioning

confidence: 95%

Analysis of Endoscopic Radiofrequency Ablation of Biliary Malignant Strictures in Pancreatic Cancer Suggests Potential Survival Benefit

et al. 2015

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“…In some cases, a biliary sphincterotomy extension and papillary balloon dilation was performed to expose the inside of the terminal bile duct for assessment and therapy. Ablative therapy was delivered using a standard Argon Plasma Coagulation (APC) probe (ERBE USA Inc., Mariette, GA) at a flow rate of 1.0 L/min to 1.2 L/min and 30 to 40 maximum watts (W) and/or the Habib EndoHPB RFA bipolar cautery probe (EMcision United Kingdom, London, United Kingdom) at 10 W for 60 to 90 seconds, extrapolating from manufacturer’s recommendations of 7 to 10 W × 120 seconds 9. Given the proximity to the pancreatic orifice and the benign nature of the target lesions, a shorter duration of treatment was chosen.…”

Section: Case Reportsmentioning

confidence: 99%

Adjunctive radiofrequency ablation for the endoscopic treatment of ampullary lesions with intraductal extension (with video)

2016

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Background and study aims: Catheter-based radiofrequency ablation (RFA) delivered during endoscopic retrograde cholangiopancreatography (ERCP) may represent a viable treatment option for intraductal extension of ampullary neoplasms, however, clinical experience with this modality is limited. After ampullary resection, 4 patients with intraductal extension underwent adjunctive RFA of the distal bile duct. All patients received a temporary pancreatic stent to reduce the risk of pancreatitis, as well as a plastic biliary stent to prevent biliary obstruction. Three patients were treated for adenoma and 1 for adenoma with a focus of adenocarcinoma. During a short follow-up period, 3 patients experienced complete eradication of the target lesion, whereas the patient with a focus of adenocarcinoma had progression to overt invasive cancer. There were no immediate adverse events. One patient developed a post-RFA bile duct stricture, which has required additional endoscopic therapy. Catheter-based RFA of ampullary lesions that extend up the bile duct is technically feasible. Additional research is necessary to understand the risks and long-term benefits of this technique.

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“…Over the last decade, much effort has been devoted to studying RFA as an adjunct therapy to stent placement. Using thermal energy, RFA induces coagulative necrosis of tumor tissue[13]. The procedure is safe and produces good 90-d stent luminal patency rates in patients with unresectable pancreatic carcinoma with obstructive jaundice[7,8].…”

Section: Discussionmentioning

confidence: 99%

Successful endoscopic treatment of an intraductal papillary neoplasm of the bile duct

Natov¹,

Horton²,

Hegde³

2017

WJGE

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We present a case of a 76-year-old man with right upper quadrant abdominal pain and weight loss, who was found to have an intraductal papillary neoplasm of the bile duct (IPNB) of the pancreaticobiliary subtype, deemed curatively resectable. The patient declined surgery and opted for endoscopic therapy. He underwent two sessions of endoscopic retrograde cholangiopancreatography (ERCP)-guided radiofrequency ablation (RFA). Ten months later, no evidence of recurrence was identified on repeat ERCP. To our knowledge, this is the first reported case of successful use of RFA as a primary treatment modality for resectable IPNB.

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Evaluation of effects of a novel endoscopically applied radiofrequency ablation biliary catheter using an ex‐vivo pig liver

Cited by 68 publications

References 15 publications

Analysis of Endoscopic Radiofrequency Ablation of Biliary Malignant Strictures in Pancreatic Cancer Suggests Potential Survival Benefit

Analysis of Endoscopic Radiofrequency Ablation of Biliary Malignant Strictures in Pancreatic Cancer Suggests Potential Survival Benefit

Adjunctive radiofrequency ablation for the endoscopic treatment of ampullary lesions with intraductal extension (with video)

Successful endoscopic treatment of an intraductal papillary neoplasm of the bile duct

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