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The Efficacy of Esomeprazole Premedication on Intraoperative Bleeding During Gastric ESD

Primary Purpose

Stomach Neoplasms

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Esomeprazole

No PPI treatment

About this trial

This is an interventional prevention trial for Stomach Neoplasms focused on measuring endoscopic submucosal dissection, proton pump inhibitor, bleeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Ability to understand and the willingness to sign a written informed consent document.
Female or male aged ≥18 years.
Patients must have gastric mucosal lesion that are eligible for ESD indications (Japanese Gastric Cancer Association 2011), including early gastric cancer, polyps, adenoma, and precancerous/suspected lesions diagnosed by endoscopy.

Exclusion Criteria:

Malignancy or other advanced disease with a life expectancy of < 6 months as judged by the investigator.
The ASA classification of physical status ≥ 4 as judged by the investigator.
Severe hepatic disease or renal disease
Ability to understand and the willingness to sign a written informed consent document.
Major cardiovascular event at enrollment or within 3 months prior to enrollment such as stroke, myocardial infarction, or hospitalization for treatment of unstable angina pectoris as judged by the investigator.
Haemorrhagic disorder.
Patients who had a history of gastrectomy or a recurrent lesion.
Known or suspected hypersensitivity to any component of any PPI .
Planned treatment with: warfarin (including other vitamin K antagonists), cisapride, phenytoin, atazanavir, nelfinavir, digoxin, methotrexate, clopidogrel, tacrolimus, theophylline, lidocaine, nifedipine.
Pregnancy, planned pregnancy or lactation. Women of childbearing potential must use reliable and medically accepted methods of birth control, as judged by the investigator.
Known or suspected alcohol, drug or medication abuse.
Any condition associated with poor compliance as judged by the investigator.
Participation in any study involving administration of an investigational product or device within the preceding 14 days prior to enrollment.
Involvement in the planning and conduct of the study. Previous enrollment in the present study.

Sites / Locations

Xijing Hospital of Digestive Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Esomeprazole group

Arm Description

No PPI treatment should given after the initial allocation. Patient will be admitted, and ESD will be performed. Then a 3-day i.v. treatment of esomeprazole will be initiated after ESD procedure and followed by a 26 days oral treatment with esomeprazole tablets 40 mg.

Esomeprazole should start as soon as possible after the initial allocation. During the 7 days of p.o. treatment, patient will be admitted, and ESD will be performed as soon as completing the p.o. treatment. Then a 3-day i.v. treatment of esomeprazole will be initiated after ESD procedure and followed by a 26 days oral treatment with esomeprazole tablets 40 mg.

Outcomes

Primary Outcome Measures

The total bleeding rate according to grading of intraoperative bleeding during ESD procedure

≥grade 1 means bleeding

Secondary Outcome Measures

The frequency of coagrasper usage which reflects grade of major bleeding

Post-ESD ulcer quality as indicated in description

Ulcer base quality will be evaluated base on the grading of clean, with minor trace of coagulation, base with extensive coagulation.

Intra-procedure injury to muscularis propria including perforation.

Injury of muscularis propria will be evaluated as no injury, minor injury and deep injury/perforation.

Mean haemoglobin reduction between intervention and control group.

Delayed bleeding rate as indicated by haematemesis and melaena

The mean percentage of mucosal defect reduction at follow-up endoscopy on 28 days after ESD procedure.

Full Information

NCT ID

NCT02730533

First Posted

March 28, 2016

Last Updated

July 19, 2017

Sponsor

Xijing Hospital of Digestive Diseases

1. Study Identification

Unique Protocol Identification Number

NCT02730533

Brief Title

The Efficacy of Esomeprazole Premedication on Intraoperative Bleeding During Gastric ESD

Official Title

The Efficacy of Esomeprazole Premedication on Intraoperative Bleeding During Gastric ESD: an Endoscopist-blinded Randomized Controlled Study

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

March 2016 (Actual)

Primary Completion Date

March 2017 (Actual)

Study Completion Date

April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Xijing Hospital of Digestive Diseases

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This will be a single-centre, randomised, endoscopist-blind, parallel-group study in patients who are scheduled endoscopic submucosal dissection (ESD) for gastric mucosal lesion. The primary objective is to observe whether a regimen of 7-day oral esomeprazole premedication can alleviate intraoperative bleeding in patients scheduled for ESD due to gastric mucosal lesions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stomach Neoplasms

Keywords

endoscopic submucosal dissection, proton pump inhibitor, bleeding

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

74 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

Arm Title

Esomeprazole group

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Esomeprazole

Intervention Description

Proton pump inhibitor

Intervention Type

Drug

Intervention Name(s)

No PPI treatment

Intervention Description

No PPI treatment before ESD procedure

Primary Outcome Measure Information:

Title

The total bleeding rate according to grading of intraoperative bleeding during ESD procedure

Description

≥grade 1 means bleeding

Time Frame

1 day

Secondary Outcome Measure Information:

Title

The frequency of coagrasper usage which reflects grade of major bleeding

Time Frame

1 day

Title

Post-ESD ulcer quality as indicated in description

Description

Ulcer base quality will be evaluated base on the grading of clean, with minor trace of coagulation, base with extensive coagulation.

Time Frame

1 day

Title

Intra-procedure injury to muscularis propria including perforation.

Description

Injury of muscularis propria will be evaluated as no injury, minor injury and deep injury/perforation.

Time Frame

1 day

Title

Mean haemoglobin reduction between intervention and control group.

Time Frame

1 day

Title

Delayed bleeding rate as indicated by haematemesis and melaena

Time Frame

30 days

Title

The mean percentage of mucosal defect reduction at follow-up endoscopy on 28 days after ESD procedure.

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Ability to understand and the willingness to sign a written informed consent document. Female or male aged ≥18 years. Patients must have gastric mucosal lesion that are eligible for ESD indications (Japanese Gastric Cancer Association 2011), including early gastric cancer, polyps, adenoma, and precancerous/suspected lesions diagnosed by endoscopy. Exclusion Criteria: Malignancy or other advanced disease with a life expectancy of < 6 months as judged by the investigator. The ASA classification of physical status ≥ 4 as judged by the investigator. Severe hepatic disease or renal disease Ability to understand and the willingness to sign a written informed consent document. Major cardiovascular event at enrollment or within 3 months prior to enrollment such as stroke, myocardial infarction, or hospitalization for treatment of unstable angina pectoris as judged by the investigator. Haemorrhagic disorder. Patients who had a history of gastrectomy or a recurrent lesion. Known or suspected hypersensitivity to any component of any PPI . Planned treatment with: warfarin (including other vitamin K antagonists), cisapride, phenytoin, atazanavir, nelfinavir, digoxin, methotrexate, clopidogrel, tacrolimus, theophylline, lidocaine, nifedipine. Pregnancy, planned pregnancy or lactation. Women of childbearing potential must use reliable and medically accepted methods of birth control, as judged by the investigator. Known or suspected alcohol, drug or medication abuse. Any condition associated with poor compliance as judged by the investigator. Participation in any study involving administration of an investigational product or device within the preceding 14 days prior to enrollment. Involvement in the planning and conduct of the study. Previous enrollment in the present study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhiguo Liu

Organizational Affiliation

Xijing Hospital of Digestive Disease

Official's Role

Principal Investigator

Facility Information:

Facility Name

Xijing Hospital of Digestive Diseases

City

Xi'an

State/Province

Shaanxi

ZIP/Postal Code

710032

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Paper publishing

Citations:

PubMed Identifier

21741645

Citation

Ahn JY, Jung HY, Choi KD, Choi JY, Kim MY, Lee JH, Choi KS, Kim DH, Song HJ, Lee GH, Kim JH, Park YS. Endoscopic and oncologic outcomes after endoscopic resection for early gastric cancer: 1370 cases of absolute and extended indications. Gastrointest Endosc. 2011 Sep;74(3):485-93. doi: 10.1016/j.gie.2011.04.038. Epub 2011 Jul 13.

Results Reference

background

PubMed Identifier

23765426

Citation

Choi MK, Kim GH, Park DY, Song GA, Kim DU, Ryu DY, Lee BE, Cheong JH, Cho M. Long-term outcomes of endoscopic submucosal dissection for early gastric cancer: a single-center experience. Surg Endosc. 2013 Nov;27(11):4250-8. doi: 10.1007/s00464-013-3030-4. Epub 2013 Jun 14.

Results Reference

background

PubMed Identifier

20623442

Citation

Deprez PH, Bergman JJ, Meisner S, Ponchon T, Repici A, Dinis-Ribeiro M, Haringsma J. Current practice with endoscopic submucosal dissection in Europe: position statement from a panel of experts. Endoscopy. 2010 Oct;42(10):853-8. doi: 10.1055/s-0030-1255563. Epub 2010 Jul 9.

Results Reference

background

PubMed Identifier

23368844

Citation

Fujishiro M, Chiu PW, Wang HP. Role of antisecretory agents for gastric endoscopic submucosal dissection. Dig Endosc. 2013 Mar;25 Suppl 1:86-93. doi: 10.1111/j.1443-1661.2012.01370.x. Epub 2013 Jan 24.

Results Reference

background

PubMed Identifier

10502182

Citation

Gotoda T, Kondo H, Ono H, Saito Y, Yamaguchi H, Saito D, Yokota T. A new endoscopic mucosal resection procedure using an insulation-tipped electrosurgical knife for rectal flat lesions: report of two cases. Gastrointest Endosc. 1999 Oct;50(4):560-3. doi: 10.1016/s0016-5107(99)70084-2. No abstract available.

Results Reference

background

PubMed Identifier

19891589

Citation

Jang JS, Choi SR, Graham DY, Kwon HC, Kim MC, Jeong JS, Won JJ, Han SY, Noh MH, Lee JH, Lee SW, Baek YH, Kim MJ, Jeong DS, Kim SK. Risk factors for immediate and delayed bleeding associated with endoscopic submucosal dissection of gastric neoplastic lesions. Scand J Gastroenterol. 2009;44(11):1370-6. doi: 10.3109/00365520903194609.

Results Reference

background

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The Efficacy of Esomeprazole Premedication on Intraoperative Bleeding During Gastric ESD

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