Pain After Endoscopic Submucosal Dissection

Gastric Neoplasm Clinical Trial

Official title:

Pain After Endoscopic Submucosal Dissection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02254889
• Other study ID #: 3-2011-0007
• Status: Completed
• Phase: N/A
• First received: September 25, 2014
• Last updated: February 11, 2016
• Start date: April 2011
• Est. completion date: December 2014

Study information

• Verified date: February 2016
• Source: Gangnam Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Gastric Neoplasm
• Stomach Neoplasms

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Da Hyun Jung	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A 10-cm VAS was used to evaluate pain after ESD.		Pain was rated at 24 hours after ESD.	Yes