GallstoneNCT06969144
Subtotal Cholecystectomy for Difficult Gall Bladder Due to Chronic Cholecystitis
An observational study of Gallstone, run by Tribhuvan University Teaching Hospital, Institute Of Medicine. at 1 site in Nepal.
Trial summary
Subtotal cholecystectomy (STC) is a valuable technique when severe inflammation, fibrosis, or anatomical variations obscure the critical view of safety essential for identifying the cystic duct and artery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gallstone
- What is being tested?
- cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 1,149 participants
- Where
- 1 siteNepal
- Study dates
- 23 Dec 2024to 13 Jan 2025
- 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: patients undergoing laparoscopic cholecystectomy
Who may be able to join
- Clinical diagnosis of cholelithiasis planned for laparoscopic cholecystectomy
- Clinical diagnosis of gallbladder polyp planned for laparoscopic cholecystectomy
Who cannot join
- Gall bladder malignancy
- Cholelithiasis and gallbladder polyp cases managed non-operatively
- additional procedures along with cholecystectomy like bile duct exploration, bile duct excision for choledochal cyst.
Trial locations and contacts
1 site in 1 country.
Nepal1 site
Tribhuvan University Teaching Hospital, Kathmandu, Nepal
Kathmandu, 44600
About this study
Official title: Subtotal Cholecystectomy for Difficult Gall Bladder Due to Chronic Cholecystitis: A Cross-sectional Study
Subtotal cholecystectomy (STC) is a valuable technique when severe inflammation, fibrosis, or anatomical variations obscure the critical view of safety essential for identifying the cystic duct and artery. It helps reduce the risk of bile duct injuries and other complications that arise during a total cholecystectomy (TC) when these structures are not visible. This study evaluates the safety and outcomes of subtotal cholecystectomy in chronic cholecystitis.
Read the detailed description
A retrospective analysis was conducted in all patients who underwent a cholecystectomy between May 2021 and November 2024. Indications, complications, and perioperative outcomes of STC were compared with those of standard TC.
The investigators concluded STC is an important bailout procedure in a difficult laparoscopic cholecystectomy associated with higher early postoperative complications but lower bile duct injury.
- Conditions
- Gallstone
- Being tested
- cholecystectomy
- Medical subject headings
- Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cholecystectomyProcedure or surgery
The indications for elective cholecystectomy were symptomatic cholelithiasis, a GB polyp more than ten millimeters, a history of cholecystitis, biliary pancreatitis, or choledocholithiasis. Patients with cholecystitis and severe or moderately severe pancreatitis were operated on after six weeks of the event. Other patients received surgery at the earliest available date. All patients with choledocholithiasis underwent endoscopic retrograde cholangiopancreatography (ERCP) and stone clearance before cholecystectomy. Patients who underwent laparoscopic cholecystectomy were evaluated by surgical and anesthesia teams in outpatient clinics and co-morbid conditions were optimized. Preoperative antibiotic prophylaxis was given to all the patients before induction of anesthesia.
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative outcomes of subtotal cholecystectomy (STC) and total cholecystectomy (TC)
The primary outcome was to assess the postoperative outcomes of subtotal cholecystectomy (STC) and total cholecystectomy (TC) groups.
Measured: upto 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start23 Dec 2024
- Primary completion12 Jan 2025
- Study completion13 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GallstoneStudies 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
- 1,149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tribhuvan University Teaching Hospital, Institute Of Medicine.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ishwor Thapaliya, Tribhuvan University Teaching Hospital, Institute Of Medicine.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06969144
- Sponsor's protocol ID
- 416(6-11)E2,081/82
- Status last verified
- Jan 2025
- First submitted
- 27 Jan 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: apart from identifiers, relevant clinical data.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subtotal Cholecystectomy for Difficult Gall Bladder Due to Chronic Cholecystitis: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06969144
- Acronym / sponsor ID
- 416(6-11)E2,081/82
- Conditions
- Gallstone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,149 participants (actual)
- Lead sponsor
- Tribhuvan University Teaching Hospital, Institute Of Medicine.University, hospital or other
- Study start
- 23 Dec 2024 (actual)
- Primary completion
- 12 Jan 2025 (actual)
- Study completion
- 13 Jan 2025 (actual)
- First posted
- 13 May 2025 (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.
Subtotal cholecystectomy (STC) is a valuable technique when severe inflammation, fibrosis, or anatomical variations obscure the critical view of safety essential for identifying the cystic duct and artery. It helps reduce the risk of bile duct injuries and other complications that arise during a total cholecystectomy (TC) when these structures are not visible. This study evaluates the safety and outcomes of subtotal cholecystectomy in chronic cholecystitis.
Detailed description
A retrospective analysis was conducted in all patients who underwent a cholecystectomy between May 2021 and November 2024. Indications, complications, and perioperative outcomes of STC were compared with those of standard TC.
The investigators concluded STC is an important bailout procedure in a difficult laparoscopic cholecystectomy associated with higher early postoperative complications but lower bile duct injury.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients undergoing laparoscopic cholecystectomy
Key inclusion criteria (2 listed)
- Clinical diagnosis of cholelithiasis planned for laparoscopic cholecystectomy
- Clinical diagnosis of gallbladder polyp planned for laparoscopic cholecystectomy
Key exclusion criteria (3 listed)
- Gall bladder malignancy
- Cholelithiasis and gallbladder polyp cases managed non-operatively
- additional procedures along with cholecystectomy like bile duct exploration, bile duct excision for choledochal cyst.
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 |
|---|---|---|
| cholecystectomyThe indications for elective cholecystectomy were symptomatic cholelithiasis, a GB polyp more than ten millimeters, a history of cholecystitis, biliary pancreatitis, or choledocholithiasis. Patients with cholecystitis and severe or moderately severe pancreatitis were operated on after six weeks of the event. Other patients received surgery at the earliest available date. All patients with choledocholithiasis underwent endoscopic retrograde cholangiopancreatography (ERCP) and stone clearance before cholecystectomy. Patients who underwent laparoscopic cholecystectomy were evaluated by surgical and anesthesia teams in outpatient clinics and co-morbid conditions were optimized. Preoperative antibiotic prophylaxis was given to all the patients before induction of anesthesia. | Procedure or surgery | – |
Primary outcome
postoperative outcomes of subtotal cholecystectomy (STC) and total cholecystectomy (TC)
Time frame: upto 22 months
The primary outcome was to assess the postoperative outcomes of subtotal cholecystectomy (STC) and total cholecystectomy (TC) groups.
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 13 May 2025.
- Individual participant dataSharing planned: Yes. apart from identifiers, relevant clinical data.
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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.
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 Gallstone, run by Tribhuvan University Teaching Hospital, Institute Of Medicine. at 1 site in Nepal.
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 3 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 13 May 2025. 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 Nepal. 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?
postoperative outcomes of subtotal cholecystectomy (STC) and total cholecystectomy (TC) (time frame: upto 22 months). 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 13 May 2025.