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

NCT ID: NCT02165852

Last Updated: 2015-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-10-31

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.

Conditions

Ampulla of Vater Adenoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Papillectomy without injection

Conventional snaring mucoal resection without submucosal injection

Group Type: EXPERIMENTAL

Papillectomy without injection

Intervention Type: PROCEDURE

Conventional endoscopic mucosal resection of ampulla of Vater using a snare with electrocurrent.

Papillectomy with injection

Conventional mucosal resction method following injeciton of diluted epinephrine mixture.

Group Type: ACTIVE_COMPARATOR

Papillectomy with injection

Intervention Type: PROCEDURE

Conventional endoscopic mucosal resection of ampulla of Vater without submucosal saline or diluted epinephrine injection.

Interventions

Papillectomy without injection

Conventional endoscopic mucosal resection of ampulla of Vater using a snare with electrocurrent.

Intervention Type: PROCEDURE

Papillectomy with injection

Conventional endoscopic mucosal resection of ampulla of Vater without submucosal saline or diluted epinephrine injection.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• ampulla of Vater adenoma
• no uncontrolled coagulopathy

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Soon Chun Hyang University

OTHER

Sponsor Role: lead

Responsible Party

Tae Hoon Lee

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tae Hoon Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

SoonChunHyang University School of Medicine

Locations

Soonchunhyang University Cheonan Hospital

Cheonan, , South Korea

Countries

South Korea

References

Hyun JJ, Lee TH, Park JS, Han JH, Jeong S, Park SM, Lee HS, Moon JH, Park SH. A prospective multicenter study of submucosal injection to improve endoscopic snare papillectomy for ampullary adenoma. Gastrointest Endosc. 2017 Apr;85(4):746-755. doi: 10.1016/j.gie.2016.08.013. Epub 2016 Aug 24.

Reference Type: DERIVED

PMID: 27566056 (View on PubMed)

Other Identifiers

Papillectomy Study

Identifier Type: -

Identifier Source: org_study_id