Pain After Endoscopic Submucosal Dissection
1 other identifier
interventional
156
1 country
1
Brief Summary
Endoscopic submucosal dissection (ESD) is widely used for local treatment of gastric neoplasms. Although ESD-related complications such as bleeding and perforation have been reported, data is currently lacking on the development of pain, which is one of the most common adverse events after ESD. Therefore, in the present study, we investigated the incidence and clinicopathologic risk factors of pain after ESD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2011
Longer than P75 for not_applicable
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
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 25, 2014
CompletedFirst Posted
Study publicly available on registry
October 2, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFebruary 12, 2016
February 1, 2016
3.7 years
September 25, 2014
February 11, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
A 10-cm VAS was used to evaluate pain after ESD.
Pain was rated at 24 hours after ESD.
Study Arms (2)
pre-ESD group
ACTIVE COMPARATORAll subjects were randomly assigned to treatment with intravenous proton pump inhibitor (PPI) before ESD.
post-ESD group
PLACEBO COMPARATORAll subjects were randomly assigned to treatment with intravenous proton pump inhibitor (PPI) after ESD.
Interventions
). In the pre-ESD therapeutic group, a standard intravenous dose of PPI was given 2 hours before ESD. In the post-ESD therapeutic group, patients also received intravenous PPI in standard doses, once in the evening after ESD.
Eligibility Criteria
You may qualify if:
- patients undergoing ESD for gastric neoplasms
You may not qualify if:
- (1) history of acid suppressive medication within 1 week prior to the procedure; (2) known gastrointestinal disorders, such as peptic ulcer disease, which might impact epigastric pain assessment; (3) current or regular use of pain medication; (4) history of upper gastrointestinal surgery; (5) multiple lesions requiring ESD; (6) perforation during ESD; and (7) significant cardiovascular, renal, hepatic, neurotic, or psychological disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Da Hyun Jung
Seoul, 120-752, South Korea
Related Publications (1)
Jung DH, Youn YH, Kim JH, Park H. Factors influencing development of pain after gastric endoscopic submucosal dissection: a randomized controlled trial. Endoscopy. 2015 Dec;47(12):1119-23. doi: 10.1055/s-0034-1392537. Epub 2015 Jul 10.
PMID: 26165736DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Young Hoon Youn, MD, PhD
Gangnam Severance Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
September 25, 2014
First Posted
October 2, 2014
Study Start
April 1, 2011
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
February 12, 2016
Record last verified: 2016-02