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

Phase 3

Completed

• Conditions: Ampulla of Vater Adenoma
• Interventions: Procedure: Papillectomy without injection; Procedure: Papillectomy with injection

• Registration Number: NCT02165852
• Lead Sponsor: Soon Chun Hyang University

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-03-25
• Study First Submitted QC: 2014-06-12
• Study First Posted: 2014-06-18
• Status Verified: 2015-10
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Last Update Submitted: 2015-10-13
• Last Update Posted: 2015-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• ampulla of Vater adenoma
• no uncontrolled coagulopathy

Exclusion Criteria

• adenocarcinoma of ampulla of Vater
• uncontrolled coagulopathy
• refusal to this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Papillectomy without injection	Papillectomy without injection	Conventional snaring mucoal resection without submucosal injection
Papillectomy with injection	Papillectomy with injection	Conventional mucosal resction method following injeciton of diluted epinephrine mixture.

Primary Outcome Measures

Name	Time	Method
complete resection	one month	Following endoscopic papillectomy, complete resection will be estimated by pathologic examination

Secondary Outcome Measures

Name	Time	Method
complication	within 24 hours	Immediate complications after papillecotmy Delayed complications during 24 hours

Trial Locations

Locations (1)

Soonchunhyang University Cheonan Hospital; 🇰🇷 Cheonan, Korea, Republic of