PancreatoduodenectomyNCT05109143
Efficacy of Rectal Indomethacin in Prevention of Post-operative Pancreatitis After Pancreaticoduodenectomy
A study testing Indomethacin suppository and Standard Medical Treatment in people with Pancreatoduodenectomy, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Pancreatico-duodenectomy is one of the commonly performed procedure for periampullary/distal cholangio/head of pancreas carcinoma. Post operative pancreatitis is an emerging concept, recently being studied as one of the most important contributing factor of Post-operative pancreatic fistula, which is one of the major… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatoduodenectomy
- What is being tested?
- Indomethacin suppository and Standard Medical Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteIndia
- Study dates
- 17 Oct 2020to 31 May 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All consenting adults planned to undergo pancreatoduodenectomy,
Who cannot join
- asthma
- allergic reactions to NSAIDs
- CKD
- internal hemorrhoids
- anti-platelet medications
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: Efficacy of Rectal Indomethacin in Prevention of Post-operative Pancreatitis After Pancreaticoduodenectomy - a Randomized Controlled Trial
Pancreatico-duodenectomy is one of the commonly performed procedure for periampullary/distal cholangio/head of pancreas carcinoma. Post operative pancreatitis is an emerging concept, recently being studied as one of the most important contributing factor of Post-operative pancreatic fistula, which is one of the major complication of pancreatoduodenectomy. Rectal indomethacin, a type of non-steroidal anti-inflammatory drug, when given in a single dose has been shown to prevent pancreatitis in patients undergoing ERCP. In this study, we will be administering rectal indomethacin at the time of induction of anesthesia to the experimental arm of the study and compare the results in terms of incidence of post-operative pancreatitis in the two groups.
- Conditions
- Pancreatoduodenectomy
- Being tested
- Indomethacin suppository, Standard Medical Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indomethacin suppositoryDrug
100mg Indomethacin Suppository administered at the time of Induction
Standard Medical TreatmentOther
Standard Medical Treatment
| Study group | Role | What they receive |
|---|---|---|
| Group B | Active comparator | Standard Medical Treatment Receives: Other: Standard Medical Treatment |
| Group A | Experimental | Will be administered 100mg of Indomethacin Suppository sigle dose at the time of induction of anesthesia with Standard Medical Treatment Receives: Drug: Indomethacin suppository; Other: Standard Medical Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Pancreatitis
Measured: first 30 days following pancreatoduodenectomy
Secondary outcomes (6)
Post-operative Pancreatic Fistula
Measured: first 30 days following pancreatoduodenectomy
delayed gastric emptying
Measured: First 30 days following pancreatoduodenectomy
intra-abdominal abscess
Measured: first 30 days following pancreatoduodenectomy
Length of ICU stay
Measured: First 30 days following pancreatoduodenectomy
Length of hospital stay
Measured: First 30 days following pancretoduodenectomy
risk factors of post-operative pancreatitis
Measured: first 30 days following pancreatoduodenectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start17 Oct 2020
- Primary completion30 Apr 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatoduodenectomyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Viniyendra Pamecha, FEBS, Study director, Institute of Liver & Biliary Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109143
- Sponsor's protocol ID
- IEC/2020/81/MA13
- Status last verified
- Oct 2021
- First submitted
- 26 Oct 2021
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Rectal Indomethacin in Prevention of Post-operative Pancreatitis After Pancreaticoduodenectomy - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05109143
- Acronym / sponsor ID
- IEC/2020/81/MA13
- Conditions
- Pancreatoduodenectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 17 Oct 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 5 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.
Pancreatico-duodenectomy is one of the commonly performed procedure for periampullary/distal cholangio/head of pancreas carcinoma. Post operative pancreatitis is an emerging concept, recently being studied as one of the most important contributing factor of Post-operative pancreatic fistula, which is one of the major complication of pancreatoduodenectomy. Rectal indomethacin, a type of non-steroidal anti-inflammatory drug, when given in a single dose has been shown to prevent pancreatitis in patients undergoing ERCP. In this study, we will be administering rectal indomethacin at the time of induction of anesthesia to the experimental arm of the study and compare the results in terms of incidence of post-operative pancreatitis in the two groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group B | Active comparator | Other: Standard Medical TreatmentStandard Medical Treatment |
| Group A | Experimental | Drug: Indomethacin suppository, Other: Standard Medical TreatmentWill be administered 100mg of Indomethacin Suppository sigle dose at the time of induction of anesthesia with Standard Medical Treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All consenting adults planned to undergo pancreatoduodenectomy,
Key exclusion criteria (5 listed)
- asthma
- allergic reactions to NSAIDs
- CKD
- internal hemorrhoids
- anti-platelet medications
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 |
|---|---|---|
| Indomethacin suppository100mg Indomethacin Suppository administered at the time of Induction | Drug | Group A |
| Standard Medical TreatmentStandard Medical Treatment | Other | Group A, Group B |
Primary outcome
Post-operative Pancreatitis
Time frame: first 30 days following pancreatoduodenectomy
6 secondary outcomes
Post-operative Pancreatic Fistula
Time frame: first 30 days following pancreatoduodenectomy
delayed gastric emptying
Time frame: First 30 days following pancreatoduodenectomy
intra-abdominal abscess
Time frame: first 30 days following pancreatoduodenectomy
Length of ICU stay
Time frame: First 30 days following pancreatoduodenectomy
Length of hospital stay
Time frame: First 30 days following pancretoduodenectomy
risk factors of post-operative pancreatitis
Time frame: first 30 days following pancreatoduodenectomy
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 6 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Pancreatoduodenectomy
Not yet recruitingObservational study
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Pancreatic Surgery, Prophylactic SBRT
Not yet recruitingObservational study
Postoperative Pancreatic Fistula Following Pancreaticoduodenectomy
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Tissue Adhesive Glue Modified Cyanoacrylate (Glubran® 2) in Soft Pancreas
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RecruitingPhase 3
Neoadjuvant vs Upfront Surgery for Resectable Pancreatic Cancer and Periampullary Cancer
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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.
Viniyendra Pamecha, FEBS study director
Institute of Liver & Biliary Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indomethacin suppository and Standard Medical Treatment in people with Pancreatoduodenectomy, 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 1 inclusion and 5 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 6 Jul 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?
Post-operative Pancreatitis (time frame: first 30 days following pancreatoduodenectomy). 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 6 Jul 2022.