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The purpose of the study is to assess the efficacy and morbidity of biliairy radiofrequency ablation for the treatment of dysplastic endobiliairy residual lesions (low-grade dysplasia or high-grade dysplasia) after endoscopic ampullectomy for ampullary adenoma.
Neoplastic lesions may persist at the termination of the common bile duct or pancreatic duct, after endoscopic ampullectomy for adenoma. Such lesions conduct to a difficult therapeutic problem because surgery (pancreaticoduodenectomy or trans-duodenal resection) has significant morbidity compared to non-invasive lesions. The use of endoscopic destruction techniques of dysplastic lesions, including radio-frequency could be an interesting alternative to reduce the risk of invasive cancer with less morbidity. Ablation with radio-frequency (RF) is a technique of local tissue destruction in use in many applications, percutaneously or intraoperatively for the treatment of hepatocellular carcinoma smaller and more recently for the endoscopic treatment of high-grade dysplasia of Barrett's esophagus. An RF probe has been developed for an endo-biliary application (Habib EndoHPB, Emcision) and 2 preliminary studies have reported the use in humans, in the indication of unresectable cholangiocarcinoma. These two studies have confirmed the feasibility of the technique, with few side effects and probable anti-tumor efficacy demonstrated by expanding the area of stenosis after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endobiliary radiofrequency | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Habibâ„¢ EndoHBP | Device | During an endoscopic retrograde cholangiography, endobiliary application of radiofrequency through a dedicated probe named Habib. |
|
| Measure | Description | Time Frame |
|---|---|---|
| number of residual neoplasia | one year |
| Measure | Description | Time Frame |
|---|---|---|
| presence of low grade dysplasia or high grade dysplasia or invasive carcinoma | 6 months | |
| number of surgery | one year | |
| fever |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29660322 | Derived | 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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| ID | Term |
|---|---|
| D002759 | Adenoma, Bile Duct |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| 48 hours post endoscopic procedure |
| pain | Visual Analogue Scale | 48 hours post endoscopic procedure |
| bleeding | hematemesis, hematochezia or melena or decreased more than 2 points of hemoglobin | 48 hours post endoscopic procedure |
| acute pancreatitis | pain and increased of lipase more than 3 fold | 48 hours post endoscopic procedure |
| cholangitis | fever and abnormal hepatic blood tests | 48 hours post endoscopic procedure |
| perforation | pneumoperitoneum, retropneumoperitoneum, pneumothorax | 48 hours post endoscopic procedure |