Pilot Trial on Efficacy of Single Dose Perioperative Intravenous Dexamethasone for Pain Relief After Endoscopic Submucosal Dissection

Trial Title: Pilot Trial on Efficacy of Single Dose Perioperative Intravenous Dexamethasone for Pain Relief After Endoscopic Submucosal Dissection

NCT ID: NCT02037399

Condition: Early Gastric Cancer or Gastric Adenoma

Conditions: Official terms:
Stomach Neoplasms
Adenoma
Dexamethasone

Conditions: Keywords:
Endoscopic submucosal dissection
early gastric cancer
pain relief
intravenous dexamethasone
present pain intensity

Study type: Interventional

Study phase: N/A

Overall status: Unknown status

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: intravenous dexamethasone
Description: Patients were enrolled in outpatient settings after evaluating appropriate ESD indications. A single study coordinator performed a randomization process by using a table of random numbers. The patients were allocated to receive intravenous dexamethasone (0.15 mg/kg) immediately after ESD. The patients with an odd number were assigned into DEXA group, and the patients with an even number were assigned into placebo group. The syringe including dexamethasone was completely covered with a paper sticker to mask treatment assignment. The operator and assisting nurse were also blinded to the study. At the day and next day of ESD, intravenous proton pump inhibitor was routinely administered to prevent complications including bleeding. At 3rd day of ESD, all patients started to take 40mg oral lansoprazole once a day and sucralfate suspension 3 times a day for 28 days.
Arm group label: intravenous dexamethasone

Intervention type: Drug
Intervention name: intravenous normal saline
Description: Patients were enrolled in outpatient settings after evaluating appropriate ESD indications. A single study coordinator performed a randomization process by using a table of random numbers. The patients were allocated to receive intravenous normal saline as placebo immediately after ESD. The patients with an odd number were assigned into DEXA group, and the patients with an even number were assigned into placebo group. The syringe including placebo was completely covered with a paper sticker to mask treatment assignment. The operator and assisting nurse were also blinded to the study. At the day and next day of ESD, intravenous proton pump inhibitor was routinely administered to prevent complications including bleeding. At 3rd day of ESD, all patients started to take 40mg oral lansoprazole once a day and sucralfate suspension 3 times a day for 28 days.
Arm group label: intravenous normal saline

Summary: Besides major ESD-related complications, minor adverse events after ESD are also commonly noticed. Pain is one of minor ESD-related complications. . The causes of pain associated with ESD or gastric polypectomy are thought to be associated with transmural burn or transmural air leak. How control localized pain for patients who suffered from pain after ESD is appearing as new medical interests. There are few studies about management strategy for pain after ESD. Glucocorticoids are used to reduce inflammation and tissue damage in various clinical settings including inflammatory disease, rheumatic disease, and so on. The efficacy of glucocorticoids for reducing pain after surgery has recently been investigated. Glucocorticoids are thought to locally inhibit collagen deposition and fibrosis and finally reduce scar-tissue formation. Especially systemic steroids are easy to achieve a continuous effect through stable serum concentrations. If pain was partially associated with acute inflammation, we assumed intravenous dexamethasone could be helpful to relieve pain after ESD based on previous studies. we aimed to assess the efficacy of single dose postoperative intravenous dexamethasone for pain relief after ESD.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 20 years of age or older - pathologically diagnosed gastric adenoma or cancer that was eligible for ESD - patients who gave written informed consent from patients or responsible family members. Exclusion Criteria: - patients who take pain killer within 48 hours or regularly at enrollment - confirmed any other disease which can induce epigastric pain such as peptic ulcer disease and gastroesophageal reflux disease - multiple gastric lesions for ESD - history of gastric surgery at enrollment - severe underlying disease including infection, cardiopulmonary disease, and diabetes.

Gender: All

Minimum age: 20 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Division of Gastroenterology, Department of Internal Medicine, Yonsei University College of Medicine

Address:
City: Seoul
Zip: 120-752
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Hyuk Lee, MD

Phone: 82-2-2228-1996
Email: leehyuk@yuhs.ac

Start date: July 2013

Completion date: February 2014

Lead sponsor:
Agency: Yonsei University
Agency class: Other

Source: Yonsei University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT02037399