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

Ampulla of Vater Adenoma Clinical Trial

Official title:

A Prospective Comparative Study of Papillectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02165852
• Other study ID #: Papillectomy Study
• Status: Completed
• Phase: Phase 3
• First received: March 25, 2014
• Last updated: October 13, 2015
• Start date: January 2014
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Soon Chun Hyang University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ampulla of Vater adenoma

• no uncontrolled coagulopathy

Exclusion Criteria:

• adenocarcinoma of ampulla of Vater

• uncontrolled coagulopathy

• refusal to this study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ampulla of Vater Adenoma

Intervention

Procedure:
• Papillectomy without injection
Conventional endoscopic mucosal resection of ampulla of Vater using a snare with electrocurrent.
• Papillectomy with injection
Conventional endoscopic mucosal resection of ampulla of Vater without submucosal saline or diluted epinephrine injection.

Locations

Country	Name	City	State
Korea, Republic of	Soonchunhyang University Cheonan Hospital	Cheonan

Sponsors (1)

Lead Sponsor	Collaborator
Soon Chun Hyang University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete resection	Following endoscopic papillectomy, complete resection will be estimated by pathologic examination	one month	No
Secondary	complication	Immediate complications after papillecotmy Delayed complications during 24 hours	within 24 hours	Yes