Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2026-03-05 @ 10:46 AM
Study NCT ID:
NCT02951169
Status:
UNKNOWN
Last Update Posted:
2016-11-01
First Post:
2016-10-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploration of Standard Surgical Indication in Gallbladder Benign Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D041761', 'term': 'Cholecystolithiasis'}, {'id': 'D002764', 'term': 'Cholecystitis'}], 'ancestors': [{'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-28', 'studyFirstSubmitDate': '2016-10-25', 'studyFirstSubmitQcDate': '2016-10-28', 'lastUpdatePostDateStruct': {'date': '2016-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Life Quality (Through GIQLI:Gastrointestinal Quality of Life Index)', 'timeFrame': 'Every three months, up to 18 months', 'description': 'Patients with surgery must including preoperative score'}], 'secondaryOutcomes': [{'measure': 'The Rate of Accidentally Gallbladder Carcinoma During Cholecystectomy', 'timeFrame': 'Through study completion, an average of 18 months'}, {'measure': 'The Rate of Abdominal Pain After Cholecystectomy', 'timeFrame': 'Through study completion, an average of 18 months'}, {'measure': 'The Rate of Diarrhea After Cholecystectomy', 'timeFrame': 'Through study completion, an average of 18 months'}, {'measure': 'The Rate of Abdominal Distension After Cholecystectomy', 'timeFrame': 'Through study completion, an average of 18 months'}, {'measure': 'Hospital Stay', 'timeFrame': 'Through study completion, an average of 18 months'}, {'measure': 'Total Expense of Patients Including Medication、Operating Costs and Check-Up Expense', 'timeFrame': 'Through study completion, an average of 18 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Gallbladder Stone', 'Cholecystitis', 'Gallbladder Polyps']}, 'referencesModule': {'references': [{'pmid': '26460661', 'type': 'RESULT', 'citation': 'da Costa DW, Bouwense SA, Schepers NJ, Besselink MG, van Santvoort HC, van Brunschot S, Bakker OJ, Bollen TL, Dejong CH, van Goor H, Boermeester MA, Bruno MJ, van Eijck CH, Timmer R, Weusten BL, Consten EC, Brink MA, Spanier BWM, Bilgen EJS, Nieuwenhuijs VB, Hofker HS, Rosman C, Voorburg AM, Bosscha K, van Duijvendijk P, Gerritsen JJ, Heisterkamp J, de Hingh IH, Witteman BJ, Kruyt PM, Scheepers JJ, Molenaar IQ, Schaapherder AF, Manusama ER, van der Waaij LA, van Unen J, Dijkgraaf MG, van Ramshorst B, Gooszen HG, Boerma D; Dutch Pancreatitis Study Group. Same-admission versus interval cholecystectomy for mild gallstone pancreatitis (PONCHO): a multicentre randomised controlled trial. Lancet. 2015 Sep 26;386(10000):1261-1268. doi: 10.1016/S0140-6736(15)00274-3.'}, {'pmid': '26375367', 'type': 'RESULT', 'citation': 'Shabanzadeh DM, Sorensen LT, Jorgensen T. A Prediction Rule for Risk Stratification of Incidentally Discovered Gallstones: Results From a Large Cohort Study. Gastroenterology. 2016 Jan;150(1):156-167.e1. doi: 10.1053/j.gastro.2015.09.002. Epub 2015 Sep 14.'}, {'pmid': '24867013', 'type': 'RESULT', 'citation': 'Cotton PB, Durkalski V, Romagnuolo J, Pauls Q, Fogel E, Tarnasky P, Aliperti G, Freeman M, Kozarek R, Jamidar P, Wilcox M, Serrano J, Brawman-Mintzer O, Elta G, Mauldin P, Thornhill A, Hawes R, Wood-Williams A, Orrell K, Drossman D, Robuck P. Effect of endoscopic sphincterotomy for suspected sphincter of Oddi dysfunction on pain-related disability following cholecystectomy: the EPISOD randomized clinical trial. JAMA. 2014 May;311(20):2101-9. doi: 10.1001/jama.2014.5220.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates life quality of patients who were diagnosed with gallbladder benign disease through Gastrointestinal Quality of Life Index (GIQLI) scale. Researchers will establish a database including 20,000 patients. Through observational followup and statistic analysis，identifing a model or scale to standardized surgical indication, help surgeons and patients determine the best treatment decision.', 'detailedDescription': 'The incidence of gallbladder benign diseases are increasing today. Most patients are accepting cholecystectomy. Is it better postoperation for this sort of patients? In other words, there is no specific indication for cholecystectomy in gallbladder benign diseases. Investigators want to explore the specific surgical indication for these patients so that surgeons could help patients make the best decision according to our evaluation model. This model may be a scale that summarizes and quantizes correlative factors of individual, which will be discussed by statisticians and experts of biliary surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients Diagnosed with Gallbladder Benign Disease.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with gallbladder benign disease, including gallbladder stone、cholecystitis and polypoid lesions of gallbladder from December 2016 to September 2018.\n* Have been clearly informed the purpose of this study, methods and other information, voluntarily participate in this study and sign informed consent.\n\nExclusion Criteria:\n\n* Complicated with bile duct stones and other biliary tract disease or suspected with gallbladder carcinoma、biliary tract cancer.\n* Complicated with severe diseases such as organ dysfunction that cannot accept surgery\n* Abdominal operation history.\n* Pregnant or lactation.\n* Coagulopathy.'}, 'identificationModule': {'nctId': 'NCT02951169', 'briefTitle': 'Exploration of Standard Surgical Indication in Gallbladder Benign Disease', 'organization': {'class': 'OTHER', 'fullName': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Multicenter Cohort Study: To Explore the Standard Surgical Indication in Gallbladder Benign Disease', 'orgStudyIdInfo': {'id': 'XH-16-034'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention. Treatment are accordance with clinical practice.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200092', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Yong Zhang, MD,PhD', 'role': 'CONTACT', 'phone': '+86 21 25078999-7905'}, {'name': 'Yong Zhang, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Houbao Liu, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Tao Suo, MD,PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jian Wang, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Wei Chen, MD,PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yajin Chen, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yunyao Xu, MD,PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Xiujun Cai, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Xiao Liang, MD,PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lin Ji, MD,PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jianying Lou, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ji Wang, MD,PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yu He, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Dajiang Li, MD,PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Minhua Zheng, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Zhaihai Mao, MD,PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Guilong Deng, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Guangwen Zhou, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Zunqiang Zhou, MD,PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Baomin Shi, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Donglei Zhou, MD,PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Feng Shen, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Chenghao Shao, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Gang Jin, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lunxiu Qin, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhang Yong', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Zhaohui Tang, Phd, MD', 'role': 'CONTACT', 'email': 'tangzhaohui@ahoo.com', 'phone': '+86 13601789458'}], 'overallOfficials': [{'name': 'Zhaohui Tang, Phd, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xinhua Hospital,School of Medicine,Shanghai Jiao Tong University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Database including 20000 patients diagnosed with gallbladder benign disease will be available in the website and investigators' article."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shanghai Shen Kang Hospital Development Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Zhaohui Tang', 'investigatorAffiliation': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}}}}