Clinical Trial: Destruction of Residual Endo-biliary Dysplastic Buds After Endoscopic Ampullectomy

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Efficacy and Safety of Endobiliairy Radiofrequency (Probe Habib TM EndoHPB) for the Destruction of Residual Endo Biliairy Dysplastic Buds After Endoscopic Ampullectomy: Prospective Multicenter Study

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Hôpital Cochin

Current Primary Outcome: number of residual neoplasia [ Time Frame: one year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • presence of low grade dysplasia or high grade dysplasia or invasive carcinoma [ Time Frame: 6 months ]
  • number of surgery [ Time Frame: one year ]
  • fever [ Time Frame: 48 hours post endoscopic procedure ]
  • pain [ Time Frame: 48 hours post endoscopic procedure ]
    Visual Analogue Scale
  • bleeding [ Time Frame: 48 hours post endoscopic procedure ]
    hematemesis, hematochezia or melena or decreased more than 2 points of hemoglobin
  • acute pancreatitis [ Time Frame: 48 hours post endoscopic procedure ]
    pain and increased of lipase more than 3 fold
  • cholangitis [ Time Frame: 48 hours post endoscopic procedure ]
    fever and abnormal hepatic blood tests
  • perforation [ Time Frame: 48 hours post endoscopic procedure ]
    pneumoperitoneum, retropneumoperitoneum, pneumothorax


Original Secondary Outcome: Same as current

Information By: Hôpital Cochin

Dates:
Date Received: June 15, 2016
Date Started: November 2012
Date Completion: February 2017
Last Updated: July 4, 2016
Last Verified: July 2016