Comparison on the Efficacy of Endoscopic Snare Papillectomy With or Without Submucosal Injection
A Prospective Comparative Study of Papillectomy
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 25, 2014
CompletedFirst Posted
Study publicly available on registry
June 18, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedOctober 15, 2015
October 1, 2015
1.7 years
March 25, 2014
October 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
complete resection
Following endoscopic papillectomy, complete resection will be estimated by pathologic examination
one month
Secondary Outcomes (1)
complication
within 24 hours
Study Arms (2)
Papillectomy without injection
EXPERIMENTALConventional snaring mucoal resection without submucosal injection
Papillectomy with injection
ACTIVE COMPARATORConventional mucosal resction method following injeciton of diluted epinephrine mixture.
Interventions
Conventional endoscopic mucosal resection of ampulla of Vater using a snare with electrocurrent.
Conventional endoscopic mucosal resection of ampulla of Vater without submucosal saline or diluted epinephrine injection.
Eligibility Criteria
You may qualify if:
- ampulla of Vater adenoma
- no uncontrolled coagulopathy
You may not qualify if:
- adenocarcinoma of ampulla of Vater
- uncontrolled coagulopathy
- refusal to this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Soonchunhyang University Cheonan Hospital
Cheonan, South Korea
Related Publications (1)
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.
PMID: 27566056DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tae Hoon Lee, MD, PhD
SoonChunHyang University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
March 25, 2014
First Posted
June 18, 2014
Study Start
January 1, 2014
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
October 15, 2015
Record last verified: 2015-10