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Pain After Endoscopic Submucosal Dissection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02254889
Recruitment Status : Completed
First Posted : October 2, 2014
Last Update Posted : February 12, 2016
Sponsor:
Information provided by (Responsible Party):
Da Hyun Jung, Gangnam Severance Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gastric Neoplasm Drug: proton pump inhibitor Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pain After Endoscopic Submucosal Dissection
Study Start Date : April 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: pre-ESD group
All subjects were randomly assigned to treatment with intravenous proton pump inhibitor (PPI) before ESD.
 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.
Placebo Comparator: post-ESD group
All subjects were randomly assigned to treatment with intravenous proton pump inhibitor (PPI) after ESD.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. A 10-cm VAS was used to evaluate pain after ESD. [ Time Frame: Pain was rated at 24 hours after ESD. ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02254889


Locations
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Korea, Republic of
Da Hyun Jung
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Gangnam Severance Hospital
Investigators
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Study Director: Young Hoon Youn, MD, PhD Gangnam Severance Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Da Hyun Jung, Doctor, Gangnam Severance Hospital
ClinicalTrials.gov Identifier: NCT02254889    
Other Study ID Numbers: 3-2011-0007
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: February 12, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
 Gastrointestinal Diseases
Stomach Diseases
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action