Pain After Endoscopic Submucosal Dissection

Not Applicable

Completed

• Conditions: Gastric Neoplasm
• Interventions: Drug: proton pump inhibitor

• Registration Number: NCT02254889
• Lead Sponsor: Gangnam Severance Hospital

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.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2014-09-25
• Study First Submitted QC: 2014-10-01
• Study First Posted: 2014-10-02
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-11
• Last Update Posted: 2016-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pre-ESD group	proton pump inhibitor	All subjects were randomly assigned to treatment with intravenous proton pump inhibitor (PPI) before ESD.
post-ESD group	proton pump inhibitor	All subjects were randomly assigned to treatment with intravenous proton pump inhibitor (PPI) after ESD.

Primary Outcome Measures

Name	Time	Method
A 10-cm VAS was used to evaluate pain after ESD.	Pain was rated at 24 hours after ESD.

Trial Locations

Locations (1)

Da Hyun Jung; 🇰🇷 Seoul, Korea, Republic of