Comparison on the Efficacy of Endoscopic Snare Papillectomy With or Without Submucosal Injection

Study Overview
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Brief Summary
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Because the ampulla of Vater is strategically located at the confluence of the pancreatic and common bile ducts, endoscopic resection of papillary neoplasms may be technically different from endoscopic mucosal resection in other parts of the gastrointestinal tract. The best method of endoscopic ablation and the optimal period for surveillance have not been established.

Detailed Description
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While some endoscopists advocate the use of submucosal injection of either physiologic saline solution or dilute epinephrine, some do not. Whether physiologic saline solution or dilute epinephrine should be used is also not established. Submucosal injection of either dilute epinephrine or saline solution may be useful for avoiding inappropriate resection because failure to lift the tumor from the proper muscle layer of the duodenum may indicate deeper invasion18 and is the strongest predictor of malignancy. In adenomas of the major duodenal papilla, however, some investigators do not recommend submucosal injection. Not only the surrounding mucosa at the region of the duodenal papilla but also the tumor is lifted by submucosal injection, so capturing the lesion with a snare becomes difficult.

Official Title
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A Prospective Comparative Study of Papillectomy

Conditions
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Ampulla of Vater Adenoma

Intervention / Treatment
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* Procedure: Papillectomy without injection
* Procedure: Papillectomy with injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ampulla of Vater adenoma no uncontrolled coagulopathy Exclusion Criteria: adenocarcinoma of ampulla of Vater uncontrolled coagulopathy refusal to this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Papillectomy without injection<br>Conventional snaring mucoal resection without submucosal injection | Procedure: Papillectomy without injection<br>* Conventional endoscopic mucosal resection of ampulla of Vater using a snare with electrocurrent.<br>|
| Active Comparator: Papillectomy with injection<br>Conventional mucosal resction method following injeciton of diluted epinephrine mixture. | Procedure: Papillectomy with injection<br>* Conventional endoscopic mucosal resection of ampulla of Vater without submucosal saline or diluted epinephrine injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete resection | Following endoscopic papillectomy, complete resection will be estimated by pathologic examination | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complication | Immediate complications after papillecotmy Delayed complications during 24 hours | within 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ampulla of Vater, adenoma, papillectomy, injection, non-injection