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Endoscopic Papillectomy for Early Ampullary Tumors: Long-term Results of the First Large Multicenter Prospective Study

NCT01764503 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 93

Last updated 2013-03-12

No results posted yet for this study

Summary

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

  • Ampullary Tumors

Sponsors & Collaborators

  • Société Française d'Endoscopie Digestive

    lead OTHER

Principal Investigators

  • Rodica Gincul, MD · Société Française d'Endoscopie Digestive

  • Bertrand Napoleon, MD · Société Française d'Endoscopie Digestive

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01764503 on ClinicalTrials.gov