Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2026-03-05 @ 2:01 PM
Study NCT ID:
NCT02730533
Status:
COMPLETED
Last Update Posted:
2017-07-21
First Post:
2016-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Esomeprazole Premedication on Intraoperative Bleeding During Gastric ESD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064098', 'term': 'Esomeprazole'}], 'ancestors': [{'id': 'D009853', 'term': 'Omeprazole'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-19', 'studyFirstSubmitDate': '2016-03-28', 'studyFirstSubmitQcDate': '2016-04-05', 'lastUpdatePostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The total bleeding rate according to grading of intraoperative bleeding during ESD procedure', 'timeFrame': '1 day', 'description': '≥grade 1 means bleeding'}], 'secondaryOutcomes': [{'measure': 'The frequency of coagrasper usage which reflects grade of major bleeding', 'timeFrame': '1 day'}, {'measure': 'Post-ESD ulcer quality as indicated in description', 'timeFrame': '1 day', 'description': 'Ulcer base quality will be evaluated base on the grading of clean, with minor trace of coagulation, base with extensive coagulation.'}, {'measure': 'Intra-procedure injury to muscularis propria including perforation.', 'timeFrame': '1 day', 'description': 'Injury of muscularis propria will be evaluated as no injury, minor injury and deep injury/perforation.'}, {'measure': 'Mean haemoglobin reduction between intervention and control group.', 'timeFrame': '1 day'}, {'measure': 'Delayed bleeding rate as indicated by haematemesis and melaena', 'timeFrame': '30 days'}, {'measure': 'The mean percentage of mucosal defect reduction at follow-up endoscopy on 28 days after ESD procedure.', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['endoscopic submucosal dissection', 'proton pump inhibitor', 'bleeding'], 'conditions': ['Stomach Neoplasms']}, 'referencesModule': {'references': [{'pmid': '21741645', 'type': 'BACKGROUND', '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.'}, {'pmid': '23765426', 'type': 'BACKGROUND', '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.'}, {'pmid': '20623442', 'type': 'BACKGROUND', '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.'}, {'pmid': '23368844', 'type': 'BACKGROUND', '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.'}, {'pmid': '10502182', 'type': 'BACKGROUND', '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.'}, {'pmid': '19891589', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to understand and the willingness to sign a written informed consent document.\n* Female or male aged ≥18 years.\n* 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.\n\nExclusion Criteria:\n\n* Malignancy or other advanced disease with a life expectancy of \\< 6 months as judged by the investigator.\n* The ASA classification of physical status ≥ 4 as judged by the investigator.\n* Severe hepatic disease or renal disease\n* Ability to understand and the willingness to sign a written informed consent document.\n* 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.\n* Haemorrhagic disorder.\n* Patients who had a history of gastrectomy or a recurrent lesion.\n* Known or suspected hypersensitivity to any component of any PPI .\n* Planned treatment with: warfarin (including other vitamin K antagonists), cisapride, phenytoin, atazanavir, nelfinavir, digoxin, methotrexate, clopidogrel, tacrolimus, theophylline, lidocaine, nifedipine.\n* Pregnancy, planned pregnancy or lactation. Women of childbearing potential must use reliable and medically accepted methods of birth control, as judged by the investigator.\n* Known or suspected alcohol, drug or medication abuse.\n* Any condition associated with poor compliance as judged by the investigator.\n* Participation in any study involving administration of an investigational product or device within the preceding 14 days prior to enrollment.\n* Involvement in the planning and conduct of the study. Previous enrollment in the present study.'}, 'identificationModule': {'nctId': 'NCT02730533', 'briefTitle': 'The Efficacy of Esomeprazole Premedication on Intraoperative Bleeding During Gastric ESD', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital of Digestive Diseases'}, 'officialTitle': 'The Efficacy of Esomeprazole Premedication on Intraoperative Bleeding During Gastric ESD: an Endoscopist-blinded Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'KY20162024-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', '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.', 'interventionNames': ['Drug: No PPI treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Esomeprazole group', 'description': '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.', 'interventionNames': ['Drug: Esomeprazole']}], 'interventions': [{'name': 'Esomeprazole', 'type': 'DRUG', 'description': 'Proton pump inhibitor', 'armGroupLabels': ['Esomeprazole group']}, {'name': 'No PPI treatment', 'type': 'DRUG', 'description': 'No PPI treatment before ESD procedure', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'Xijing Hospital of Digestive Diseases', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'overallOfficials': [{'name': 'Zhiguo Liu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xijing Hospital of Digestive Disease'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Paper publishing'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital of Digestive Diseases', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Zhiguo Liu', 'investigatorAffiliation': 'Xijing Hospital of Digestive Diseases'}}}}