Back to resultsPain After Endoscopic Submucosal Dissection
Primary Purpose
Gastric Neoplasm
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
proton pump inhibitor
Sponsored by
About this trial
This is an interventional prevention trial for Gastric Neoplasm
Eligibility Criteria
Inclusion Criteria:
- patients undergoing ESD for gastric neoplasms
Exclusion Criteria:
- (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
Sites / Locations
- Da Hyun Jung
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
pre-ESD group
post-ESD group
Arm Description
All subjects were randomly assigned to treatment with intravenous proton pump inhibitor (PPI) before ESD.
All subjects were randomly assigned to treatment with intravenous proton pump inhibitor (PPI) after ESD.
Outcomes
Primary Outcome Measures
A 10-cm VAS was used to evaluate pain after ESD.
Secondary Outcome Measures
Full Information
NCT ID
NCT02254889
First Posted
September 25, 2014
Last Updated
February 11, 2016
Sponsor
Gangnam Severance Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02254889
Brief Title
Pain After Endoscopic Submucosal Dissection
Official Title
Pain After Endoscopic Submucosal Dissection
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gangnam Severance Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
A prospective randomized controlled study was conducted evaluating 156 patients with gastric neoplasms treated by ESD at Gangnam Severance Hospital between April 2011 and December 2014. All subjects were randomly assigned to treatment with intravenous proton pump inhibitor (PPI) either before or after ESD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Neoplasm
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
156 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pre-ESD group
Arm Type
Active Comparator
Arm Description
All subjects were randomly assigned to treatment with intravenous proton pump inhibitor (PPI) before ESD.
Arm Title
post-ESD group
Arm Type
Placebo Comparator
Arm Description
All subjects were randomly assigned to treatment with intravenous proton pump inhibitor (PPI) after ESD.
Intervention Type
Drug
Intervention Name(s)
proton pump inhibitor
Intervention Description
). 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.
Primary Outcome Measure Information:
Title
A 10-cm VAS was used to evaluate pain after ESD.
Time Frame
Pain was rated at 24 hours after ESD.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients undergoing ESD for gastric neoplasms
Exclusion Criteria:
(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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young Hoon Youn, MD, PhD
Organizational Affiliation
Gangnam Severance Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Da Hyun Jung
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
26165736
Citation
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.
Results Reference
derived
Learn more about this trial
Pain After Endoscopic Submucosal Dissection
We'll reach out to this number within 24 hrs