HPB MalignanciesNCT07480005
To Revisit the Yield of Staging Laparoscopy in Hepatopancreatobiliary Malignancies
An observational study of HPB Malignancies, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
This research project, to be conducted at the Institute of Liver \& Biliary Sciences, aims to evaluate the effectiveness of staging laparoscopy (SL) in detecting occult metastases in hepatopancreatobiliary (HPB) malignancies in the current era of advanced imaging modalities such as MDCT, MRI, EUS, and PET-CT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HPB Malignancies
- How many people
- 350 participants
- Where
- 1 siteIndia
- Study dates
- 18 Mar 2026to 30 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients of perihilar and hilar cholangiocarcinoma, carcinoma gall bladder, hepatocellular carcinoma, periampullary malignancies and intrahepatic cholangiocarcinoma undergoing staging laparoscopy before surgery for curative intent
Who may be able to join
- -
- All patients with suspected HPB malignancies undergoing staging laparoscopy before proceeding to laparotomy.
- Pre-op CT scans of cut size less than or equal to 1.5 mm
Who cannot join
- Patients undergoing staging laparoscopy without intent of curative resection in the same sitting.
- malignancies other than adenocarcinoma
- Final histopathology is benign
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
Rahul shivhare, MS, 01143600000, rahulshivhare93@gmail.com
About this study
This research project, to be conducted at the Institute of Liver \& Biliary Sciences, aims to evaluate the effectiveness of staging laparoscopy (SL) in detecting occult metastases in hepatopancreatobiliary (HPB) malignancies in the current era of advanced imaging modalities such as MDCT, MRI, EUS, and PET-CT. While SL is a minimally invasive technique that aids in identifying radiologically undetectable metastases, its utility in routine practice is under scrutiny due to improved imaging accuracy. The study is premised on the hypothesis that the yield of SL is low in the current imaging era, questioning its routine application.
The study uses an ambispective cohort design and includes all patients undergoing SL for HPB malignancies from January 2012 to March 2026 at ILBS, Delhi. The primary objective is to assess the yield of SL, while secondary objectives include evaluating false positives/negatives, the added value of PET-CT over CT, and identifying clinical or radiological predictors of positive SL.
Read more
Subgroup analyses will be performed for different HPB cancers including periampullary malignancies, gallbladder cancer, hilarcholangiocarcinoma, intrahepatic cholangiocarcinoma, pancreatic ductal adenocarcinoma, and hepatocellular carcinoma. Data collection includes demographics, tumor markers, imaging findings, SL results, duration, and associated costs.
Findings from this study could inform refined criteria for the selective use of SL, avoiding unnecessary surgeries and optimizing resource utilization. This could lead to evidence-based guidelines for staging practices in HPB cancers, balancing clinical benefits against costs and surgical risks in the context of modern diagnostic capabilities.
- Conditions
- HPB Malignancies
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
NO INTERVENTION AS THIS IS AN OBSERVATIONAL STUDY
| Study group | Role | What they receive |
|---|---|---|
| carcinoma gall bladder | suspected CaGb patients based on preoperative imaging undergoing staging laparoscopy and the final histopathology suggestive of adenocarcinoma of gall bladder Receives: Other: No intervention | |
| Hepatocellular carcinoma | suspected HCC patients based on preoperative imaging undergoing staging laparoscopy and the final histopathology suggestive of HCC Receives: Other: No intervention | |
| Perihilar and hilar cholangiocarcinoma | suspected Perihilar and hilar cholangiocarcinoma patients based on preoperative imaging undergoing staging laparoscopy and the final histopathology suggestive of adenocarcinoma Receives: Other: No intervention | |
| Peri-ampullary Malignancy | suspected Peri-ampullary Malignancy patients based on preoperative imaging undergoing staging laparoscopy and the final histopathology suggestive of adenocarcinoma Receives: Other: No intervention | |
| Intrahepatic cholangiocarcinoma | suspected Intrahepatic cholangiocarcinoma patients based on preoperative imaging undergoing staging laparoscopy and the final histopathology suggestive of adenocarcinoma Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
the yield of staging laparoscopy in HPB malignancies
proportion of patients with positive staging laparoscopy (Metastatic disease/unresectable) findings leading to abandonement of procedure
Measured: DAY 0
Secondary outcomes (3)
Positive findings on SL leading to abandonment
findings like peritoneal/liver/omental nodules which are postive on frozen section proving metastatic disease
Measured: DAY 0
False positive findings
findings like peritoneal/liver/omental nodules which are negative on frozen section
Measured: DAY 0
Additional findings reported on laparotomy after SL
finding of nodules/metastatis on laparotomy which are not detected on staging laparoscopy
Measured: DAY 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start18 Mar 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPB MalignanciesStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe 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
- Cross-sectional
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480005
- Sponsor's protocol ID
- ILBS-HPBMALIGNANCY-O1
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Revisit the Yield of Staging Laparoscopy in Hepatopancreatobiliary Malignancies
- ClinicalTrials.gov ID
- NCT07480005
- Acronym / sponsor ID
- ILBS-HPBMALIGNANCY-O1
- Conditions
- HPB Malignancies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 18 Mar 2026 (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.
This research project, to be conducted at the Institute of Liver \& Biliary Sciences, aims to evaluate the effectiveness of staging laparoscopy (SL) in detecting occult metastases in hepatopancreatobiliary (HPB) malignancies in the current era of advanced imaging modalities such as MDCT, MRI, EUS, and PET-CT. While SL is a minimally invasive technique that aids in identifying radiologically undetectable metastases, its utility in routine practice is under scrutiny due to improved imaging accuracy. The study is premised on the hypothesis that the yield of SL is low in the current imaging era, questioning its routine application.
The study uses an ambispective cohort design and includes all patients undergoing SL for HPB malignancies from January 2012 to March 2026 at ILBS, Delhi. The primary objective is to assess the yield of SL, while secondary objectives include evaluating false positives/negatives, the added value of PET-CT over CT, and identifying clinical or radiological predictors of positive SL.
Subgroup analyses will be performed for different HPB cancers including periampullary malignancies, gallbladder cancer, hilarcholangiocarcinoma, intrahepatic cholangiocarcinoma, pancreatic ductal adenocarcinoma, and hepatocellular carcinoma. Data collection includes demographics, tumor markers, imaging findings, SL results, duration, and associated costs.
Findings from this study could inform refined criteria for the selective use of SL, avoiding unnecessary surgeries and optimizing resource utilization. This could lead to evidence-based guidelines for staging practices in HPB cancers, balancing clinical benefits against costs and surgical risks in the context of modern diagnostic capabilities.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| carcinoma gall bladder | – | Other: No interventionsuspected CaGb patients based on preoperative imaging undergoing staging laparoscopy and the final histopathology suggestive of adenocarcinoma of gall bladder |
| Hepatocellular carcinoma | – | Other: No interventionsuspected HCC patients based on preoperative imaging undergoing staging laparoscopy and the final histopathology suggestive of HCC |
| Perihilar and hilar cholangiocarcinoma | – | Other: No interventionsuspected Perihilar and hilar cholangiocarcinoma patients based on preoperative imaging undergoing staging laparoscopy and the final histopathology suggestive of adenocarcinoma |
| Peri-ampullary Malignancy | – | Other: No interventionsuspected Peri-ampullary Malignancy patients based on preoperative imaging undergoing staging laparoscopy and the final histopathology suggestive of adenocarcinoma |
| Intrahepatic cholangiocarcinoma | – | Other: No interventionsuspected Intrahepatic cholangiocarcinoma patients based on preoperative imaging undergoing staging laparoscopy and the final histopathology suggestive of adenocarcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients of perihilar and hilar cholangiocarcinoma, carcinoma gall bladder, hepatocellular carcinoma, periampullary malignancies and intrahepatic cholangiocarcinoma undergoing staging laparoscopy before surgery for curative intent
Key inclusion criteria (3 listed)
- -
- All patients with suspected HPB malignancies undergoing staging laparoscopy before proceeding to laparotomy.
- Pre-op CT scans of cut size less than or equal to 1.5 mm
Key exclusion criteria (3 listed)
- Patients undergoing staging laparoscopy without intent of curative resection in the same sitting.
- malignancies other than adenocarcinoma
- Final histopathology is benign
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 AS THIS IS AN OBSERVATIONAL STUDY | Other | Hepatocellular carcinoma, Intrahepatic cholangiocarcinoma, Peri-ampullary Malignancy, Perihilar and hilar cholangiocarcinoma, carcinoma gall bladder |
Primary outcome
the yield of staging laparoscopy in HPB malignancies
Time frame: DAY 0
proportion of patients with positive staging laparoscopy (Metastatic disease/unresectable) findings leading to abandonement of procedure
3 secondary outcomes
Positive findings on SL leading to abandonment
Time frame: DAY 0
False positive findings
Time frame: DAY 0
Additional findings reported on laparotomy after SL
Time frame: DAY 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 HPB Malignancies, run by Institute of Liver and Biliary Sciences, India 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?
The sponsor lists 3 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: looking for participants now, as of the sponsor's last update on 23 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rahul Shivhare, MS (01146300000, rahulshivhare93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the yield of staging laparoscopy in HPB malignancies (time frame: DAY 0). 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 23 Mar 2026.