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

October 13, 2015 updated by: Tae Hoon Lee, Soon Chun Hyang University

A Prospective Comparative Study of Papillectomy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Cheonan, Korea, Republic of
        • Soonchunhyang University Cheonan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ampulla of Vater adenoma
  • no uncontrolled coagulopathy

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soon Chun Hyang University

Investigators

  • Principal Investigator: Tae Hoon Lee, MD, PhD, Soonchunhyang University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

March 25, 2014

First Submitted That Met QC Criteria

June 12, 2014

First Posted (Estimate)

June 18, 2014

Study Record Updates

Last Update Posted (Estimate)

October 15, 2015

Last Update Submitted That Met QC Criteria

October 13, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Papillectomy Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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