Clinical trial · Observational
Endoscopic Papillectomy for Early Ampullary Tumors: Long-term Results of the First Large Multicenter Prospective Study
to Evaluate the Long-term Results of Endoscopic Papillectomy (EP)
- 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)
Adenoma of the ampulla of Vater is rare but represents a large proportion of benign tumors occurring in the small intestine. The symptoms are usually non specific or due to pancreaticobiliary obstruction . The diagnosis can also be made in asymptomatic patients during an upper gastrointestinal endoscopy. Finally, the adenoma can be discovered during a screening procedure in patients with Familial Adenomatous Polyposis (FAP). It has been demonstrated that ampullary adenomas have a malignant potential mimicking the "adenoma-adenocarcinoma" sequence already described in the colon. So, a complete removal is mandatory. The only exception is represented by subnormal ampulla with low grade dysplasia (LGD) adenoma discovered during screening follow-up of FAP patients. In these cases the situation can be stable during several years leading to simple, annual or biannual surveillance. Historically, the treatment was surgical, associated with a high mortality and morbidity rate for pancreaticoduodenectomy (PD) and a high recurrence rate for transduodenal resection (26 to 43%). Endoscopic papillectomy (EP) represents an alternative for patients with a benign or at least non-invasive ampullary tumor. Unlike thermal ablative methods by laser photoablation or argon plasma destruction, EP allows adequate histologic evaluation especially in case of en-bloc resection. This technique has been increasingly used in the last decade with very promising results. Nevertheless the long-term results have mainly been reported in retrospective monocentric series. We intended to evaluate, in the first large multicenter prospective study, the long-term results of endoscopic papillectomy.
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 |
|---|---|---|---|
| Ampullary Tumors | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Long-term results of Endoscopic Papillectomy (EP) for early ampullary tumor
- timeFrame
- 3 years
- description
- To describe the curative and recurrence rate of endoscopic papillectomy for early ampullary tumor
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Adenoma with at least low grade dysplasia (LGD) was required for inclusion Two other criteria were needed in asymptomatic patients with LGD : * an ampullary size \> 1 cm at endoscopy in case of Familial Adenomatous Polyposis (FAP) ; * two series of positive biopsies in case of sporadic tumors * uT1N0 lesion at EUS (tumor without invasion of the muscularis propria (MP) of the duodenum and no suspicious lymph nodes) * without intraductal growth (pancreatic and/or common bile duct) Exclusion criteria were: * previously treated ampulloma; * metastatic disease at CT-scan; * advanced tumor at duodenoscopy (ulceration or induration involving the duodenal roof of the papilla); * advanced tumor (uT2 = invasion of the MP without invasion of the pancreas ; uT3 = invasion of pancreas and/or N+ suspicious lymph nodes) and/or intraductal invasion at EUS * absence of adenoma on the resected specimen. Exclusion Criteria: * adenoma not confirmed
References
Publications (1)
- DERIVEDNapoleon B, Gincul R, Ponchon T, Berthiller J, Escourrou J, Canard JM, Boyer J, Barthet M, Ponsot P, Laugier R, Helbert T, Coumaros D, Scoazec JY, Mion F, Saurin JC; Societe Francaise d'Endoscopie Digestive (SFED, French Society of Digestive Endoscopy). Endoscopic papillectomy for early ampullary tumors: long-term results from a large multicenter prospective study. Endoscopy. 2014 Feb;46(2):127-34. doi: 10.1055/s-0034-1364875. Epub 2014 Jan 29. PMID 24477368