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Endoscopic papillectomy is the preferred approach for management of ampullary adenomas. Endobiliary radiofrequency ablation (RFA) is an ablative therapy that has been used to treat malignant biliary strictures. The aim of this study was to evaluate the safety and efficacy of endoscopic papillectomy combined with endobiliary RFA for ampullary neoplasms with intraductal biliary extension.
Ampullary neoplasms remain rare, with a reported prevalence of 0.04% to 0.12% in autopsy studies. , endoscopic papillectomy is now recognized as a safe and reliable alternative to surgery for ampullary adenomas and is associated with high success rates (72%-95%), low morbidity (10%-30%), and minimal mortality (0.2%-1%). Typically, however, intrabiliary extension of the adenoma has been regarded as a contraindication for endoscopic papillectomy. Surgical referral is therefore recommended with intraductal extension, particularly when the length of extension exceeds 1 cm. Radiofrequency ablation offers a potentially safe and effective treatment for malignant biliary strictures. The use of RFA as a primary treatment for intraductal dysplasia after endoscopic papillectomy has been shown in few small case series to be feasible with the primary limitation of short follow-up periods. The primary aim of this study was to describe our experience with RFA in patients with ampullary neoplasia and associated intraductal extension who were not surgical candidates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EP combined with RFA | Experimental | Endoscopic Papillectomy Combined with Endobiliary Radiofrequency Ablation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic Papillectomy | Procedure | A snare devicewas inserted via the working channel, and the endoscopist adjusted the snare to securely grasp the lesion, which was then excised by using standard electrocautery. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence | Recurrence was defined as discovery of neoplasia after a negative surveillance endoscopy and biopsy | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Complete resection of ampullary adenomas | Complete resection of ampullary adenomas was confirmed when no residual tissue was found on ampullary and intraductal biopsies at the 3-month follow-up ERCP. | three months |
| Endoscopic success |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianfeng Yang, Dr. | First People's Hospital of Hangzhou | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hangzhou First People's Hospital | Hangzhou | Zhejiang | 310006 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28610856 | Background | Watson RR, Muthusamy VR. Radiofrequency ablation for intraductal extension of ampullary neoplasms: Are we ready to feel the burn? Gastrointest Endosc. 2017 Jul;86(1):177-179. doi: 10.1016/j.gie.2016.12.022. No abstract available. | |
| 29660322 | Background | Camus M, Napoleon B, Vienne A, Le Rhun M, Leblanc S, Barret M, Chaussade S, Robin F, Kaddour N, Prat F. Efficacy and safety of endobiliary radiofrequency ablation for the eradication of residual neoplasia after endoscopic papillectomy: a multicenter prospective study. Gastrointest Endosc. 2018 Sep;88(3):511-518. doi: 10.1016/j.gie.2018.04.2332. Epub 2018 Apr 13. |
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| Endobiliary Radiofrequency Ablation | Procedure | The RFA catheter was then placed under fluoroscopic guidance across the distal common bile duct. An ERBE VIO200D generator (ERBE Elktromedizin, Tubingen, Germany) was connected for RFA at 10 W for 90 seconds. |
|
Endoscopic success was defined as complete ablation of the lesion without residual neoplasia or recurrence at the 6-month follow-up endoscopy.
| six months |
| adverse events | adverse events such as bleeding, acute pancreatitis after procedure | one months |
| 29342492 | Background | Yang J, Wang J, Zhou H, Zhou Y, Wang Y, Jin H, Lou Q, Zhang X. Efficacy and safety of endoscopic radiofrequency ablation for unresectable extrahepatic cholangiocarcinoma: a randomized trial. Endoscopy. 2018 Aug;50(8):751-760. doi: 10.1055/s-0043-124870. Epub 2018 Jan 17. |