Back to resultsComparison on the Efficacy of Endoscopic Snare Papillectomy With or Without Submucosal Injection
Primary Purpose
Ampulla of Vater Adenoma
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Papillectomy without injection
Papillectomy with injection
Sponsored by
About this trial
This is an interventional treatment trial for Ampulla of Vater Adenoma focused on measuring ampulla of Vater, adenoma, papillectomy, injection, non-injection
Eligibility Criteria
Inclusion Criteria:
- ampulla of Vater adenoma
- no uncontrolled coagulopathy
Exclusion Criteria:
- adenocarcinoma of ampulla of Vater
- uncontrolled coagulopathy
- refusal to this study
Sites / Locations
- Soonchunhyang University Cheonan Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Papillectomy without injection
Papillectomy with injection
Arm Description
Conventional snaring mucoal resection without submucosal injection
Conventional mucosal resction method following injeciton of diluted epinephrine mixture.
Outcomes
Primary Outcome Measures
complete resection
Following endoscopic papillectomy, complete resection will be estimated by pathologic examination
Secondary Outcome Measures
complication
Immediate complications after papillecotmy Delayed complications during 24 hours
Full Information
NCT ID
NCT02165852
First Posted
March 25, 2014
Last Updated
October 13, 2015
Sponsor
Soon Chun Hyang University
1. Study Identification
Unique Protocol Identification Number
NCT02165852
Brief Title
Comparison on the Efficacy of Endoscopic Snare Papillectomy With or Without Submucosal Injection
Official Title
A Prospective Comparative Study of Papillectomy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Soon Chun Hyang University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ampulla of Vater Adenoma
Keywords
ampulla of Vater, adenoma, papillectomy, injection, non-injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Papillectomy without injection
Arm Type
Experimental
Arm Description
Conventional snaring mucoal resection without submucosal injection
Arm Title
Papillectomy with injection
Arm Type
Active Comparator
Arm Description
Conventional mucosal resction method following injeciton of diluted epinephrine mixture.
Intervention Type
Procedure
Intervention Name(s)
Papillectomy without injection
Intervention Description
Conventional endoscopic mucosal resection of ampulla of Vater using a snare with electrocurrent.
Intervention Type
Procedure
Intervention Name(s)
Papillectomy with injection
Intervention Description
Conventional endoscopic mucosal resection of ampulla of Vater without submucosal saline or diluted epinephrine injection.
Primary Outcome Measure Information:
Title
complete resection
Description
Following endoscopic papillectomy, complete resection will be estimated by pathologic examination
Time Frame
one month
Secondary Outcome Measure Information:
Title
complication
Description
Immediate complications after papillecotmy Delayed complications during 24 hours
Time Frame
within 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ampulla of Vater adenoma
no uncontrolled coagulopathy
Exclusion Criteria:
adenocarcinoma of ampulla of Vater
uncontrolled coagulopathy
refusal to this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tae Hoon Lee, MD, PhD
Organizational Affiliation
SoonChunHyang University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soonchunhyang University Cheonan Hospital
City
Cheonan
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
27566056
Citation
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.
Results Reference
derived
Learn more about this trial
Comparison on the Efficacy of Endoscopic Snare Papillectomy With or Without Submucosal Injection
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