Pain After Endoscopic Submucosal Dissection

Study Overview
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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.

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.

Official Title
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Pain After Endoscopic Submucosal Dissection

Conditions
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Gastric Neoplasm

Intervention / Treatment
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* Drug: proton pump inhibitor


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: pre-ESD group<br>All subjects were randomly assigned to treatment with intravenous proton pump inhibitor (PPI) before ESD. | Drug: proton pump inhibitor<br>* ). 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.<br>|
| Placebo Comparator: post-ESD group<br>All subjects were randomly assigned to treatment with intravenous proton pump inhibitor (PPI) after ESD. | Drug: proton pump inhibitor<br>* ). 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A 10-cm VAS was used to evaluate pain after ESD. |  | Pain was rated at 24 hours after ESD. |