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Exploration of Standard Surgical Indication in Gallbladder Benign Disease

NCT ID: NCT02951169

Last Updated: 2016-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gallbladder Stone Cholecystitis Gallbladder Polyps

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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No intervention

No intervention. Treatment are accordance with clinical practice.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with gallbladder benign disease, including gallbladder stone、cholecystitis and polypoid lesions of gallbladder from December 2016 to September 2018.
* Have been clearly informed the purpose of this study, methods and other information, voluntarily participate in this study and sign informed consent.

Exclusion Criteria

* Complicated with bile duct stones and other biliary tract disease or suspected with gallbladder carcinoma、biliary tract cancer.
* Complicated with severe diseases such as organ dysfunction that cannot accept surgery
* Abdominal operation history.
* Pregnant or lactation.
* Coagulopathy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Shen Kang Hospital Development Center

OTHER

Sponsor Role collaborator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Zhaohui Tang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhaohui Tang, Phd, MD

Role: PRINCIPAL_INVESTIGATOR

Xinhua Hospital,School of Medicine,Shanghai Jiao Tong University

Locations

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Zhang Yong

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Zhaohui Tang, Phd, MD

Role: CONTACT

Phone: +86 13601789458

Email: [email protected]

Facility Contacts

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Yong Zhang, MD,PhD

Role: primary

References

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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.

Reference Type RESULT
PMID: 26460661 (View on PubMed)

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.

Reference Type RESULT
PMID: 26375367 (View on PubMed)

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.

Reference Type RESULT
PMID: 24867013 (View on PubMed)

Other Identifiers

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XH-16-034

Identifier Type: -

Identifier Source: org_study_id