Gallbladder StoneNCT02951169
Exploration of Standard Surgical Indication in Gallbladder Benign Disease
An observational study of Gallbladder Stone and Cholecystitis, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gallbladder Stone, Cholecystitis, Gallbladder Polyps
- How many people
- 20,000 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients Diagnosed with Gallbladder Benign Disease.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhang Yong
Shanghai, Shanghai Municipality, 200092
Yong Zhang, MD,PhD, +86 21 25078999-7905
Yong Zhang, MD,PhD
About this study
Official title: Multicenter Cohort Study: To Explore the Standard Surgical Indication in Gallbladder Benign Disease
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.
Read the detailed description
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
- Gallbladder Stone, Cholecystitis, Gallbladder Polyps
- Being tested
- No intervention
- Medical subject headings
- Cholecystolithiasis, Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention. Treatment are accordance with clinical practice.
What is being measured
The primary outcome is the main question the study is designed to answer.
Life Quality (Through GIQLI:Gastrointestinal Quality of Life Index)
Patients with surgery must including preoperative score
Measured: Every three months, up to 18 months
Secondary outcomes (6)
The Rate of Accidentally Gallbladder Carcinoma During Cholecystectomy
Measured: Through study completion, an average of 18 months
The Rate of Abdominal Pain After Cholecystectomy
Measured: Through study completion, an average of 18 months
The Rate of Diarrhea After Cholecystectomy
Measured: Through study completion, an average of 18 months
The Rate of Abdominal Distension After Cholecystectomy
Measured: Through study completion, an average of 18 months
Hospital Stay
Measured: Through study completion, an average of 18 months
Total Expense of Patients Including Medication、Operating Costs and Check-Up Expense
Measured: Through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionSep 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gallbladder StoneStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Shen Kang Hospital Development Center
- Responsible party
- Principal investigator, Zhaohui Tang, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Zhaohui Tang, Phd, MD, Principal investigator, Xinhua Hospital,School of Medicine,Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02951169
- Sponsor's protocol ID
- XH-16-034
- Status last verified
- Oct 2016
- First submitted
- 25 Oct 2016
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Database including 20000 patients diagnosed with gallbladder benign disease will be available in the website and investigators' article.
Publications
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.
PubMed 26460661Shabanzadeh 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.
PubMed 26375367Cotton 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.
PubMed 24867013
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Cohort Study: To Explore the Standard Surgical Indication in Gallbladder Benign Disease
- ClinicalTrials.gov ID
- NCT02951169
- Acronym / sponsor ID
- XH-16-034
- Conditions
- Gallbladder Stone, Cholecystitis, Gallbladder Polyps
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Shanghai Shen Kang Hospital Development Center
- Study start
- Dec 2016
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 1 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients Diagnosed with Gallbladder Benign Disease.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention. Treatment are accordance with clinical practice. | Other | – |
Primary outcome
Life Quality (Through GIQLI:Gastrointestinal Quality of Life Index)
Time frame: Every three months, up to 18 months
Patients with surgery must including preoperative score
6 secondary outcomes
The Rate of Accidentally Gallbladder Carcinoma During Cholecystectomy
Time frame: Through study completion, an average of 18 months
The Rate of Abdominal Pain After Cholecystectomy
Time frame: Through study completion, an average of 18 months
The Rate of Diarrhea After Cholecystectomy
Time frame: Through study completion, an average of 18 months
The Rate of Abdominal Distension After Cholecystectomy
Time frame: Through study completion, an average of 18 months
Hospital Stay
Time frame: Through study completion, an average of 18 months
Total Expense of Patients Including Medication、Operating Costs and Check-Up Expense
Time frame: Through study completion, an average of 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
- Results publication: PubMed 26460661da 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.
- Results publication: PubMed 26375367Shabanzadeh 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.
- Results publication: PubMed 24867013Cotton 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.
- Individual participant dataSharing planned: Yes. Database including 20000 patients diagnosed with gallbladder benign disease will be available in the website and investigators' article.
Related trials for Gallbladder Stone
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
Active, not recruiting
Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
Gallstones, Pain
RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
Cholelithiasis
Recruiting
Timing of CHolecystectomy In Severe PAncreatitis
Acute Pancreatitis, Cholelithiasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhaohui Tang, Phd, MD principal investigator
Xinhua Hospital,School of Medicine,Shanghai Jiao Tong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gallbladder Stone and Cholecystitis, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhaohui Tang, Phd, MD (+86 13601789458, tangzhaohui@ahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Life Quality (Through GIQLI:Gastrointestinal Quality of Life Index) (time frame: Every three months, up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02951169, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2016.