Gallbladder Malignant NeoplasmNCT05606029
A Case Series on Incidentally Detected Gallbladder Malignancy
An observational study of Gallbladder Malignant Neoplasm, run by Osmania Medical College at 1 site in India.
Trial summary
A retrospective analysis of data, using the Hospital records of all the patients who underwent cholecystectomy for benign conditions at Osmania General Hospital in a year (2019). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gallbladder Malignant Neoplasm
- What is being tested?
- Cholecystectomy, extended cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2019to 31 Dec 2019
- 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: All the patients who underwent cholecystectomy for benign conditions like gall stones, polyps,. Etc,.
Inclusion Criteria: All patients who underwent cholecystectomy for benign conditions -
Exclusion Criteria: All those who already diagnosed with gallbladder malignancy
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Case Series On Incidentally Detected Gallbladder Malignancy
A retrospective analysis of data, using the Hospital records of all the patients who underwent cholecystectomy for benign conditions at Osmania General Hospital in a year (2019).
Read the detailed description
A retrospective analysis of hospital records of patients who underwent Cholecystectomy in a year duration (2019) for any benign condition, diagnosed and confirmed histopathologically as Gallbladder Malignancy.
There are a total of one hundred and eighty patients who underwent cholecystectomy at our hospital (Osmania General Hospital) in 2019, out of which seven patients' histopathological diagnosis was gall bladder malignancy. We reviewed all the case's history, cross-checked the histopathological slides, and confirmed the diagnosis. To avoid the bias of covid-19 pandemic in surgical practice we confined the patient records to the pre-pandemic period of one-year duration (2019).
A total of 180 patients underwent cholecystectomy for various benign conditions in one year, out of which seven patients confirmed histopathologically with Gallbladder malignancy.
Total no of patients : 180 Diagnosed with malignancy : 7 percentage 3.8%
Among these seven, three patients converted from laparoscopic to open procedure for difficulty with resection, two patients are posted for surgery considering empyema of gall bladder preoperatively, one patient in view of gall bladder perforation, and for two patients preoperative diagnosis was gall bladder polyp.
Converted from Lap to Open: 3 Pre-op GB Polyp : 2 Perforated GB : 1 Empyema GB : 2
Only one patient is 40 years old and others are more than 50 years, and two of them are males.
Total : 7 100% Males : 2 28.5% Females : 5 71.5%
Out of a total of 180 patients who underwent cholecystectomy, 117 are females and 63 are males
Total : 180 Males : 63 Females : 117
Out of 180, the age distribution is as follows
Age. Percentage 20 - 29 0 30 - 39 0 40 - 49 0.005 >50. 99.99
It implies that the malignancy rate increases with an increase in the patient's age more than 50years and also with gender (Females > males).
- Conditions
- Gallbladder Malignant Neoplasm
- Being tested
- Cholecystectomy, extended cholecystectomy
- Keywords
- Gallbladder,, Polyp, Gallstones, Malignancy, Perforation
- Medical subject headings
- Gallbladder Neoplasms, Polyps, Gallstones, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cholecystectomy, extended cholecystectomyProcedure or surgery
Also called Histopathological evaluation of the specimen
Cholecystectomy and histopathological evaluation
| Study group | Role | What they receive |
|---|---|---|
| Patients who underwent cholecystectomy for benign conditions | In those who underwent cholecystectomy for benign conditions, the histopathological analysis showed the malignancy. Receives: Procedure: Cholecystectomy, extended cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosed with Gallbladder malignancy
Those who underwent cholecystectomy for benign conditions are diagnosed with gallbladder malignancy
Measured: For one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start1 Jan 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gallbladder Malignant NeoplasmStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osmania Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Sathaiah Dadi, Osmania Medical College
- Investigators
- Sathaiah Dadi, MS Gen Surg, Principal investigator, Osmania Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05606029
- Sponsor's protocol ID
- SOUMY2345
- Status last verified
- Nov 2022
- First submitted
- 25 Oct 2022
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case Series On Incidentally Detected Gallbladder Malignancy
- ClinicalTrials.gov ID
- NCT05606029
- Acronym / sponsor ID
- SOUMY2345
- Conditions
- Gallbladder Malignant Neoplasm
- Keywords
- Gallbladder,, Polyp, Gallstones, Malignancy, Perforation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Osmania Medical CollegeOther government
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 4 Nov 2022 (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.
A retrospective analysis of data, using the Hospital records of all the patients who underwent cholecystectomy for benign conditions at Osmania General Hospital in a year (2019).
Detailed description
A retrospective analysis of hospital records of patients who underwent Cholecystectomy in a year duration (2019) for any benign condition, diagnosed and confirmed histopathologically as Gallbladder Malignancy.
There are a total of one hundred and eighty patients who underwent cholecystectomy at our hospital (Osmania General Hospital) in 2019, out of which seven patients' histopathological diagnosis was gall bladder malignancy. We reviewed all the case's history, cross-checked the histopathological slides, and confirmed the diagnosis. To avoid the bias of covid-19 pandemic in surgical practice we confined the patient records to the pre-pandemic period of one-year duration (2019).
A total of 180 patients underwent cholecystectomy for various benign conditions in one year, out of which seven patients confirmed histopathologically with Gallbladder malignancy.
Total no of patients : 180 Diagnosed with malignancy : 7 percentage 3.8%
Among these seven, three patients converted from laparoscopic to open procedure for difficulty with resection, two patients are posted for surgery considering empyema of gall bladder preoperatively, one patient in view of gall bladder perforation, and for two patients preoperative diagnosis was gall bladder polyp.
Converted from Lap to Open: 3 Pre-op GB Polyp : 2 Perforated GB : 1 Empyema GB : 2
Only one patient is 40 years old and others are more than 50 years, and two of them are males.
Total : 7 100% Males : 2 28.5% Females : 5 71.5%
Out of a total of 180 patients who underwent cholecystectomy, 117 are females and 63 are males
Total : 180 Males : 63 Females : 117
Out of 180, the age distribution is as follows
Age. Percentage 20 - 29 0 30 - 39 0 40 - 49 0.005 >50. 99.99
It implies that the malignancy rate increases with an increase in the patient's age more than 50years and also with gender (Females > males).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who underwent cholecystectomy for benign conditions | – | Procedure: Cholecystectomy, extended cholecystectomyIn those who underwent cholecystectomy for benign conditions, the histopathological analysis showed the malignancy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the patients who underwent cholecystectomy for benign conditions like gall stones, polyps,. Etc,.
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 |
|---|---|---|
| Cholecystectomy, extended cholecystectomyAlso: Histopathological evaluation of the specimenCholecystectomy and histopathological evaluation | Procedure or surgery | Patients who underwent cholecystectomy for benign conditions |
Primary outcome
Diagnosed with Gallbladder malignancy
Time frame: For one year
Those who underwent cholecystectomy for benign conditions are diagnosed with gallbladder malignancy
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 4 Nov 2022.
- Individual participant dataSharing planned: No
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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.
Sathaiah Dadi, MS Gen Surg principal investigator
Osmania Medical College
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 Malignant Neoplasm, run by Osmania Medical College at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 4 Nov 2022. 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 India. 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?
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?
Diagnosed with Gallbladder malignancy (time frame: For one year). 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 4 Nov 2022.