Gall Bladder CarcinomaIGBCNCT05114369
Does Timing of Completion Radical Cholecystectomy Determine the Survival in Incidental Carcinoma Gallbladder
An observational study of Gall Bladder Carcinoma and Survival, run by Sanjay Gandhi Postgraduate Institute of Medical Sciences.
Trial summary
Various factors determine the long term survival in this non-uniform cohort of incidental gallbladder cancer. Timing of re-intervention is suggested to play an important role in the outcome. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gall Bladder Carcinoma, Survival
- What is being tested?
- Curative surgery
- Type of treatment
- Surgery or procedure
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2009to 1 Oct 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All incidental carcinoma gallbladder patients who were admitted for possible curative resection during the study period (Jan 2009 to Dec 2018)
Who may be able to join
- All incidental carcinoma gallbladder patients who could undergo curative resection during the study period (Jan 2009 to Dec 2018)
Who cannot join
- Metastasis on preoperative investigation or on staging laparoscopy
About this study
Official title: Does Timing of Completion Radical Cholecystectomy Determine the Survival Outcome in Incidental Carcinoma Gallbladder - a Single Center Retrospective Analysis
Various factors determine the long term survival in this non-uniform cohort of incidental gallbladder cancer. Timing of re-intervention is suggested to play an important role in the outcome. Few centers are proponents of early surgery in order to prevent dissemination, while others have suggested an intentional delay of 3 months to filter out cases with aggressive pathology. In the present study, investigators intend to evaluate the factors affecting survival in incidental Gallbladder Cancer (IGBC) with special reference to timing of re-intervention.
Read the detailed description
Surgical Gastroenterology department at our institute is a tertiary referral center for hepatobiliary malignancies; covering a large part of North and North-east India. The details and progress reports of patients of Gallbladder Cancer (GBC) being referred to and treated at the institute is maintained in a prospective manner on hospital data base. This includes demographic data, presenting complains, details of relevant investigations done outside and in the hospital, previous surgery, pre-hospital course, operative findings, post operative course and final histopathology. Being a retrospective analysis of data not affecting clinical outcomes, ethical approval was not taken. During the study period (Jan 2009 to Dec 2018), 1049 participants with diagnosis of GBC (including 91 IGBC participants) were admitted; 239/958 participants with diagnosis of GBC and 48/91 with diagnosis of GBC could undergo resection with curative intent. Information regarding adjuvant therapy, recurrence, and survival were retrieved through data maintained on follow up out-patient cards till December 2019. Few participants who stopped visiting the hospital were contacted telephonically or through letters. All available histopathology blocks and slides following the index cholecystectomy were re-reviewed by the pathologists in the institute. Tumor type, differentiation and primary T stage were documented for majority of cases. Interval between index cholecystectomy and date of re-operation was calculated for all the participants and divided into 3 groups: Early (<4weeks), Intermediate (4-12 weeks) and Late (>12 weeks). Primary objective was to assess the effect of tumor characteristics and the time gap (between index surgery and re-resection) on overall survival following curative (R0/R1) resection.
- Conditions
- Gall Bladder Carcinoma, Survival
- Being tested
- Curative surgery
- Keywords
- Incidental, Gallbladder cancer, Re-resection, Survival
- Medical subject headings
- Gallbladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curative surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Early (<4weeks), Intermediate (4-12 weeks) and Late (>12 weeks) | Interval between index cholecystectomy and radical re-resection with curative intent Receives: Procedure: Curative surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival based on timing of completion radical cholecystectomy
Overall and disease free survival
Measured: 01.01.2009 to 31.12.2018
Secondary outcomes (1)
Determinants of factors associated with survival in incidental gallbladder carcinoma
Factors related to primary surgery (residual disease, primary T stage), type of resection (Wedge resection, Segment 4B-5 excision or Common bile duct excision), tumor characteristics (differentiation and lymohovascular invasion) and final stage (AJCC 8th edition)
Measured: 01.01.2009 to 31.12.2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start1 Jan 2009
- Primary completion31 Dec 2018
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gall Bladder CarcinomaStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanjay Gandhi Postgraduate Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05114369
- Sponsor's protocol ID
- 00
- Acronym
- IGBC
- Status last verified
- Nov 2021
- First submitted
- 11 Oct 2021
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The final data sheet can be shared and not the individual data as the data was retrieved from online database
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Timing of Completion Radical Cholecystectomy Determine the Survival Outcome in Incidental Carcinoma Gallbladder - a Single Center Retrospective Analysis
- ClinicalTrials.gov ID
- NCT05114369
- Acronym / sponsor ID
- IGBC / 00
- Conditions
- Gall Bladder Carcinoma, Survival
- Keywords
- Incidental, Gallbladder cancer, Re-resection, Survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Sanjay Gandhi Postgraduate Institute of Medical SciencesOther government
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 10 Nov 2021 (actual)
- 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.
Various factors determine the long term survival in this non-uniform cohort of incidental gallbladder cancer. Timing of re-intervention is suggested to play an important role in the outcome. Few centers are proponents of early surgery in order to prevent dissemination, while others have suggested an intentional delay of 3 months to filter out cases with aggressive pathology. In the present study, investigators intend to evaluate the factors affecting survival in incidental Gallbladder Cancer (IGBC) with special reference to timing of re-intervention.
Detailed description
Surgical Gastroenterology department at our institute is a tertiary referral center for hepatobiliary malignancies; covering a large part of North and North-east India. The details and progress reports of patients of Gallbladder Cancer (GBC) being referred to and treated at the institute is maintained in a prospective manner on hospital data base. This includes demographic data, presenting complains, details of relevant investigations done outside and in the hospital, previous surgery, pre-hospital course, operative findings, post operative course and final histopathology. Being a retrospective analysis of data not affecting clinical outcomes, ethical approval was not taken. During the study period (Jan 2009 to Dec 2018), 1049 participants with diagnosis of GBC (including 91 IGBC participants) were admitted; 239/958 participants with diagnosis of GBC and 48/91 with diagnosis of GBC could undergo resection with curative intent. Information regarding adjuvant therapy, recurrence, and survival were retrieved through data maintained on follow up out-patient cards till December 2019. Few participants who stopped visiting the hospital were contacted telephonically or through letters. All available histopathology blocks and slides following the index cholecystectomy were re-reviewed by the pathologists in the institute. Tumor type, differentiation and primary T stage were documented for majority of cases. Interval between index cholecystectomy and date of re-operation was calculated for all the participants and divided into 3 groups: Early (<4weeks), Intermediate (4-12 weeks) and Late (>12 weeks). Primary objective was to assess the effect of tumor characteristics and the time gap (between index surgery and re-resection) on overall survival following curative (R0/R1) resection.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early (<4weeks), Intermediate (4-12 weeks) and Late (>12 weeks) | – | Procedure: Curative surgeryInterval between index cholecystectomy and radical re-resection with curative intent |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All incidental carcinoma gallbladder patients who were admitted for possible curative resection during the study period (Jan 2009 to Dec 2018)
Key inclusion criteria (1 listed)
- All incidental carcinoma gallbladder patients who could undergo curative resection during the study period (Jan 2009 to Dec 2018)
Key exclusion criteria (1 listed)
- Metastasis on preoperative investigation or on staging laparoscopy
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 |
|---|---|---|
| Curative surgery | Procedure or surgery | Early (<4weeks), Intermediate (4-12 weeks) and Late (>12 weeks) |
Primary outcome
Survival based on timing of completion radical cholecystectomy
Time frame: 01.01.2009 to 31.12.2018
Overall and disease free survival
1 secondary outcome
Determinants of factors associated with survival in incidental gallbladder carcinoma
Time frame: 01.01.2009 to 31.12.2018
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- Individual participant dataSharing planned: No. The final data sheet can be shared and not the individual data as the data was retrieved from online database
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Gall Bladder Carcinoma and Survival, run by Sanjay Gandhi Postgraduate Institute of Medical Sciences.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival based on timing of completion radical cholecystectomy (time frame: 01.01.2009 to 31.12.2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Nov 2021.