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Destruction of Residual Endo-biliary Dysplastic Buds After Endoscopic Ampullectomy (endoHPB)

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ClinicalTrials.gov Identifier: NCT02825524
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : August 28, 2017
Sponsor:
Information provided by (Responsible Party):
Frederic PRAT, Hôpital Cochin

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.

Condition or disease Intervention/treatment Phase
Adenoma, Bile Duct Device: Habib™ EndoHBP Not Applicable

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : November 2012
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: Endobiliary radiofrequency Device: Habib™ EndoHBP
During an endoscopic retrograde cholangiography, endobiliary application of radiofrequency through a dedicated probe named Habib.




Primary Outcome Measures :
  1. number of residual neoplasia [ Time Frame: one year ]

Secondary Outcome Measures :
  1. presence of low grade dysplasia or high grade dysplasia or invasive carcinoma [ Time Frame: 6 months ]
  2. number of surgery [ Time Frame: one year ]
  3. fever [ Time Frame: 48 hours post endoscopic procedure ]
  4. pain [ Time Frame: 48 hours post endoscopic procedure ]
    Visual Analogue Scale

  5. bleeding [ Time Frame: 48 hours post endoscopic procedure ]
    hematemesis, hematochezia or melena or decreased more than 2 points of hemoglobin

  6. acute pancreatitis [ Time Frame: 48 hours post endoscopic procedure ]
    pain and increased of lipase more than 3 fold

  7. cholangitis [ Time Frame: 48 hours post endoscopic procedure ]
    fever and abnormal hepatic blood tests

  8. perforation [ Time Frame: 48 hours post endoscopic procedure ]
    pneumoperitoneum, retropneumoperitoneum, pneumothorax



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Presence of lesions of low-grade dysplasia (LGD) or high grade (HGD) in the common bile duct, confirmed by two pathological readings in relation to residual adenomatous tissue into the common bile duct after endoscopic ampullectomy for ampullome conducted in the previous year
  • Lack of residual adenomatous lesion on the duodenal side after ampullectomy and possibly additional procedures (endoscopic mucosal resection or argon plasma). (excluding other duodenal adenomatous lesions in the context of familial adenomatous polyposis
  • Consultative multidisciplinary digestive cancer meeting confirming the indication of treatment with endo-biliary radio-frequency
  • Dysplastic lesions extending over 20 mm length maximum in the common bile duct
  • Patients aged ≥ 18 years old and ≤ 85 years old
  • Patients who consented to participate in the study
  • No anesthesia contraindication (ASA 1,2,3)
  • Patient affiliated to a social security scheme (beneficiary or legal)
  • Lack of pregnancy and contraception being women age procreate

Exclusion Criteria:

  • Lesions of invasive carcinoma in a patient whose clinical condition allows to consider a pancreaticoduodenectomy
  • Endo-biliary dysplastic lesions diffuse or multifocal
  • Presence of non extractable metal biliary expansive prosthesis
  • History of pancreaticoduodenectomy or hepaticojejunostomy anastomosis
  • Impassable stenosis of the common bile duct
  • Severe coagulopathy, thrombocytopenia < 75,000 G/L , Clopidogrel treatment impossible to stop temporarily
  • Anesthesia contraindication ( ASA 4)
  • Pace maker or other active implantable medical device
  • Inability to obtain informed consent

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Frederic PRAT, clinical professor, Hôpital Cochin
ClinicalTrials.gov Identifier: NCT02825524     History of Changes
Other Study ID Numbers: 2011-A00721-40
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: August 28, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Adenoma
Adenoma, Bile Duct
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms