The Efficacy of Esomeprazole Premedication on Intraoperative Bleeding During Gastric ESD

Stomach Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02730533
• Other study ID #: KY20162024-1
• Status: Completed
• Phase: N/A
• First received: March 28, 2016
• Last updated: July 19, 2017
• Start date: March 2016
• Est. completion date: April 2017

Study information

• Verified date: July 2017
• Source: Xijing Hospital of Digestive Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: April 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Hemorrhage
• Stomach Neoplasms

Intervention

Drug:
• Esomeprazole
Proton pump inhibitor
• No PPI treatment
No PPI treatment before ESD procedure

Locations

Country	Name	City	State
China	Xijing Hospital of Digestive Diseases	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital of Digestive Diseases

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View 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. — View 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. Review. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The total bleeding rate according to grading of intraoperative bleeding during ESD procedure	=grade 1 means bleeding	1 day
Secondary	The frequency of coagrasper usage which reflects grade of major bleeding		1 day
Secondary	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.	1 day
Secondary	Intra-procedure injury to muscularis propria including perforation.	Injury of muscularis propria will be evaluated as no injury, minor injury and deep injury/perforation.	1 day
Secondary	Mean haemoglobin reduction between intervention and control group.		1 day
Secondary	Delayed bleeding rate as indicated by haematemesis and melaena		30 days
Secondary	The mean percentage of mucosal defect reduction at follow-up endoscopy on 28 days after ESD procedure.		30 days