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Pain After Endoscopic Submucosal Dissection

Y

Yonsei University Health System (YUHS)

Status

Completed

Conditions

Gastric Neoplasm

Treatments

Drug: proton pump inhibitor

Study type

Interventional

Funder types

Other

Identifiers

NCT02254889
3-2011-0007

Details and patient eligibility

About

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.

Full 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.

Enrollment

156 patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

156 participants in 2 patient groups, including a placebo group

pre-ESD group
Active Comparator group
Description:
All subjects were randomly assigned to treatment with intravenous proton pump inhibitor (PPI) before ESD.
Treatment:
Drug: proton pump inhibitor
post-ESD group
Placebo Comparator group
Description:
All subjects were randomly assigned to treatment with intravenous proton pump inhibitor (PPI) after ESD.
Treatment:
Drug: proton pump inhibitor

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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