Periampullary CarcinomaNCT03722732
Comparison of Blood Loss in Laparoscopic vs Open Pancreaticoduodenectomy in Patients With Periampullary Carcinoma
A study testing pancreaticoduodenectomy in people with Periampullary Carcinoma, run by Govind Ballabh Pant Hospital at 1 site in India.
Trial summary
the study is designed to compare the blood loss between laparoscopic vs open pancreaticoduodenectomy in a randomized clinical trial Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periampullary Carcinoma
- What is being tested?
- pancreaticoduodenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIndia
- Study dates
- 11 Sep 2018to Mar 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both the sex aged between >18 years.
- Patients with a diagnosis of resectable periampullary carcinoma on imaging.
- Patients with ASA grade 1 or 2
Who cannot join
- 1) Patients found to have unresectable disease on radiological investigation. 2) Patients with ASA grade 3 or above
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
G B Pant Hospital
New Delhi, National Capital Territory of Delhi, 110002
hirdaya h nag, ms, 91 11 23234242 ext. 5220, hirdayanag@gmail.com
hirdaya h nag, ms
About this study
Official title: Comparison of Blood Loss in Laparoscopic vs Open Pancreaticoduodenectomy in Patients With Periampullary Carcinoma - A Randomized Clinical Trial
the study is designed to compare the blood loss between laparoscopic vs open pancreaticoduodenectomy in a randomized clinical trial
Read the detailed description
the study will assess the difference in the amount of blood loss in Lap vs Open WPD. the amount of blood loss will be calculated on the basis of a formula which takes pre operative and post operative hematocrit, PCV and blood volume into consideration.
- Conditions
- Periampullary Carcinoma
- Being tested
- pancreaticoduodenectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pancreaticoduodenectomyProcedure or surgery
pancreaticoduodenectomy either laparoscopically or open will be done
| Study group | Role | What they receive |
|---|---|---|
| Open pancreaticoduedenectomy | Active comparator | will include all the patients who will undergo open pancreaticoduodenectomy Receives: Procedure: pancreaticoduodenectomy |
| Laparoscopic pancreaticoduodenectomy | Active comparator | will include all the patients undergoing laparoscopic pancreaticoduodenectomy Receives: Procedure: pancreaticoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative blood loss in ml, quantitative
blood loss will be assessed with the help of a formula which uses preoperative and post operative hematocrit, blood volume and PCV
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start11 Sep 2018
- Primary completionDec 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periampullary 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Govind Ballabh Pant Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hirdaya H Nag, MS, Govind Ballabh Pant Hospital
- Investigators
- H H Nag, MS, Principal investigator, GBPant Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722732
- Sponsor's protocol ID
- F.1/IEC/MAMC/63/03/18/NO325
- Status last verified
- Jul 2021
- First submitted
- 2 Oct 2018
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chauhan V, Sharma A, Nag HH, Shetty A, Saluja SS, Sachdeva S, Chandra S, Sakhuja P. Laparoscopic versus open pancreaticoduodenectomy in patients with periampullary carcinoma: A randomised clinical trial. J Minim Access Surg. 2026 Jun 2. doi: 10.4103/jmas.jmas_581_25. Online ahead of print.
PubMed 42262773
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Blood Loss in Laparoscopic vs Open Pancreaticoduodenectomy in Patients With Periampullary Carcinoma - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03722732
- Acronym / sponsor ID
- F.1/IEC/MAMC/63/03/18/NO325
- Conditions
- Periampullary Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Govind Ballabh Pant HospitalOther government
- Study start
- 11 Sep 2018 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 29 Oct 2018 (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.
the study is designed to compare the blood loss between laparoscopic vs open pancreaticoduodenectomy in a randomized clinical trial
Detailed description
the study will assess the difference in the amount of blood loss in Lap vs Open WPD. the amount of blood loss will be calculated on the basis of a formula which takes pre operative and post operative hematocrit, PCV and blood volume into consideration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open pancreaticoduedenectomy | Active comparator | Procedure: pancreaticoduodenectomywill include all the patients who will undergo open pancreaticoduodenectomy |
| Laparoscopic pancreaticoduodenectomy | Active comparator | Procedure: pancreaticoduodenectomywill include all the patients undergoing laparoscopic pancreaticoduodenectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of both the sex aged between >18 years.
- Patients with a diagnosis of resectable periampullary carcinoma on imaging.
- Patients with ASA grade 1 or 2
Key exclusion criteria (1 listed)
- 1) Patients found to have unresectable disease on radiological investigation. 2) Patients with ASA grade 3 or above
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 |
|---|---|---|
| pancreaticoduodenectomypancreaticoduodenectomy either laparoscopically or open will be done | Procedure or surgery | Laparoscopic pancreaticoduodenectomy, Open pancreaticoduedenectomy |
Primary outcome
intraoperative blood loss in ml, quantitative
Time frame: 24 hours
blood loss will be assessed with the help of a formula which uses preoperative and post operative hematocrit, blood volume and PCV
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- Derived from this study: PubMed 42262773Chauhan V, Sharma A, Nag HH, Shetty A, Saluja SS, Sachdeva S, Chandra S, Sakhuja P. Laparoscopic versus open pancreaticoduodenectomy in patients with periampullary carcinoma: A randomised clinical trial. J Minim Access Surg. 2026 Jun 2. doi: 10.4103/jmas.jmas_581_25. Online ahead of print.
- 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.
H H Nag, MS principal investigator
GBPant Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pancreaticoduodenectomy in people with Periampullary Carcinoma, run by Govind Ballabh Pant Hospital 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 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: status not confirmed, as of the sponsor's last update on 2 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact H H Nag, MS (9718599260, hirdayanag@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraoperative blood loss in ml, quantitative (time frame: 24 hours). 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 NCT03722732, which also lists 1 linked publication.
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 2 Aug 2021.