Pain After Endoscopic Submucosal Dissection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gastric Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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pre-ESD group

All subjects were randomly assigned to treatment with intravenous proton pump inhibitor (PPI) before ESD.

Group Type ACTIVE_COMPARATOR

proton pump inhibitor

Intervention Type DRUG

). 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.

post-ESD group

All subjects were randomly assigned to treatment with intravenous proton pump inhibitor (PPI) after ESD.

Group Type PLACEBO_COMPARATOR

proton pump inhibitor

Intervention Type DRUG

). 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.

Interventions

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proton pump inhibitor

). 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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No