Clinical trial · Interventional
Destruction of Residual Endo-biliary Dysplastic Buds After Endoscopic Ampullectomy
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
NCT02825524CI-TRIAL-00029287endoHPBcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenoma, Bile Duct | Bile Duct Adenoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Habib™ EndoHBP | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Endobiliary radiofrequency
- interventionNames
- Device: Habib™ EndoHBP
Primary outcomes (1)
- measure
- number of residual neoplasia
- timeFrame
- one year
Secondary outcomes (8)
- measure
- presence of low grade dysplasia or high grade dysplasia or invasive carcinoma
- timeFrame
- 6 months
- measure
- number of surgery
- timeFrame
- one year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDCamus 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. PMID 29660322