Post Operative Pancreatic FistulaNCT05291923
Predictors of Severity of Postoperative Pancreatic Fistula After Pancreatoduodenectomy
An observational study of Post Operative Pancreatic Fistula, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Pancreaticoduodenectomy is one of the commonly performed procedure for periampullary carcinoma/distal cholangio carcinoma/head of pancreas carcinoma. Postoperative pancreatic fistula remains the most important postoperative complication following pancreatic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Pancreatic Fistula
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 16 Apr 2022to 5 Mar 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients undergoing pancreatoduodenectomy at ILBS
Who may be able to join
- Consecutive patients undergoing Pancreatoduodenectomy at ILBS
- Duct to mucosa pancreaticojejunostomy
Who cannot join
- Refused for consent
- Age < 18 yrs
- Hepatopancreatoduodenectomy
- Multi-visceral resection
- Re-exploration before POD 5
- Pancreaticogastrostomy
- Dunking type of pancreaticojejunostomy
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: Predictors of Severity of Postoperative Pancreatic Fistula After Pancreatoduodenectomy.
Pancreaticoduodenectomy is one of the commonly performed procedure for periampullary carcinoma/distal cholangio carcinoma/head of pancreas carcinoma. Postoperative pancreatic fistula remains the most important postoperative complication following pancreatic surgery. It's severity ranges from biochemical leak to grade C POPF which can lead to mortality. Radiological and biochemical parameters in early postoperative period predicts the severity of POPF after pancreatoduodenectomy. In this study, we will be evaluating the biochemical parameters and imaging findings as predictors of the severity of postoperative pancreatic fistula after pancreatoduodenectomy in early postoperative period.
Read the detailed description
(a) Aim and Objective - The aim of this study is to evaluate the biochemical parameters and imaging findings as predictors of the severity of postoperative pancreatic fistula after pancreatoduodenectomy in early postoperative period
Methodology:
- Study population: All those operated for pancreatoduodenectomy during the period of December 2021 to May 2023 will be enrolled in this study, meeting the inclusion and exclusion criteria. On an average 3-4 cases are operated per month in ILBS.
- Study design: Prospective observational study.
- Study period: From the date of clearance by the Institutional Ethics Committee, till May 2023.
- Sample size with justification: All consecutive patients undergoing pancreatoduodenectomy for the above-mentioned study period (expected sample size 40)
- Intervention: none.
- Monitoring and assessment:
- Definitions: International study group on pancreatic fistula definition of Post-Operative Pancreatic Fistula POPF) will be used which are as follows: drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content greater than 3 times the serum amylase activity
Variables to be assessed:
Patient characteristics - Age, Sex, Height, Weight, BMI, Serum albumin levels, Pancreatic parenchymal thickness- at spleno-portal confluence, Indication of Pancreatoduodenectomy -Peri ampullary mass, head of pancreatic mass, distal cholangiocarcinoma Operative Parameters - Duration of surgery, Blood Loss, Pancreatic consistency, Intraoperative remnant pancreatic parenchymal thickness at pancreatojejunostomy site/ spleno portal confluence.
Postoperative measurements -
- Drain Fluid amylase (POD 1,3 \& 5) \& serum amylase
- Serum Procalcitonin, C-reactive protein and albumin (POD 5)
- Remnant pancreatic parenchymal thickness \& change in thickness at pancreaticojejunostomy site/splenoportal confluence on NCCT abdomen (POD 5)
- Presence \& location of intra-abdominal collection by NCCT abdomen (POD 5)
- Interventions required if any for management of complications
Statistical Analysis: Data will be entered into Excel Worksheet and statistical analyses will be performed by SPSS Statistics version 22 (IBM Corp., Armonk, NY). Statistical data will be represented as frequencies (%) where the continuous variables will be expressed as medians and interquartile range (IQR). Continuous variables will be compared with the student t test and Mann-Whitney test as appropriate. Differences between proportions derived from categorical data will be compared with Chi-square or Fischer's exact test. Variables will be correlated with clinical outcomes. ROC curve will be used for biochemical markers and imaging findings Repeated analyses of measures will be applied wherever applicable.
Adverse effects: None
- Conditions
- Post Operative Pancreatic Fistula
- 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
| Study group | Role | What they receive |
|---|---|---|
| Post whipple's procedure patients | Not described Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in pancreatic parenchymal thickness at pancreaticojejunostomy site/spleno-portal confluence on postoperative day 5 predicts the severity of postoperative pancreatic fistula after pancreatoduodenectomy in early postoperative period
Measured: Post operative day 5
Secondary outcomes (5)
Levels of C-reactive protein among the different grades of post operative pancreatic fistula
Measured: Post operative day 5
Levels of serum albumin among the different grades of postoperative pancreatic fistula.
Measured: Post operative day 5
Levels of serum procalcitonin among the different grades of postoperative pancreatic fistula.
Measured: Post operative day 5
Intra-abdominal collection among the different grades of postoperative pancreatic fistula by NCCT abdomen.
Measured: Post operative day 5
Location of intra-abdominal collection among the different grades of postoperative pancreatic fistula by NCCT abdomen.
Measured: Post operative day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start16 Apr 2022
- Primary completion3 Mar 2024
- Study completion5 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Pancreatic FistulaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Piyush Kumar Sinha, MCh, Study director, Institute of Liver and Biliary Sciences, New Delhi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291923
- Sponsor's protocol ID
- ILBS-POPF-01
- Status last verified
- Oct 2023
- First submitted
- 14 Mar 2022
- Last updated
- 7 May 2024
- 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 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Severity of Postoperative Pancreatic Fistula After Pancreatoduodenectomy.
- ClinicalTrials.gov ID
- NCT05291923
- Acronym / sponsor ID
- ILBS-POPF-01
- Conditions
- Post Operative Pancreatic Fistula
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 16 Apr 2022 (actual)
- Primary completion
- 3 Mar 2024 (actual)
- Study completion
- 5 Mar 2024 (actual)
- First posted
- 23 Mar 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.
Pancreaticoduodenectomy is one of the commonly performed procedure for periampullary carcinoma/distal cholangio carcinoma/head of pancreas carcinoma. Postoperative pancreatic fistula remains the most important postoperative complication following pancreatic surgery. It's severity ranges from biochemical leak to grade C POPF which can lead to mortality. Radiological and biochemical parameters in early postoperative period predicts the severity of POPF after pancreatoduodenectomy. In this study, we will be evaluating the biochemical parameters and imaging findings as predictors of the severity of postoperative pancreatic fistula after pancreatoduodenectomy in early postoperative period.
Detailed description
(a) Aim and Objective - The aim of this study is to evaluate the biochemical parameters and imaging findings as predictors of the severity of postoperative pancreatic fistula after pancreatoduodenectomy in early postoperative period
Methodology:
- Study population: All those operated for pancreatoduodenectomy during the period of December 2021 to May 2023 will be enrolled in this study, meeting the inclusion and exclusion criteria. On an average 3-4 cases are operated per month in ILBS.
- Study design: Prospective observational study.
- Study period: From the date of clearance by the Institutional Ethics Committee, till May 2023.
- Sample size with justification: All consecutive patients undergoing pancreatoduodenectomy for the above-mentioned study period (expected sample size 40)
- Intervention: none.
- Monitoring and assessment:
- Definitions: International study group on pancreatic fistula definition of Post-Operative Pancreatic Fistula POPF) will be used which are as follows: drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content greater than 3 times the serum amylase activity
Variables to be assessed:
Patient characteristics - Age, Sex, Height, Weight, BMI, Serum albumin levels, Pancreatic parenchymal thickness- at spleno-portal confluence, Indication of Pancreatoduodenectomy -Peri ampullary mass, head of pancreatic mass, distal cholangiocarcinoma Operative Parameters - Duration of surgery, Blood Loss, Pancreatic consistency, Intraoperative remnant pancreatic parenchymal thickness at pancreatojejunostomy site/ spleno portal confluence.
Postoperative measurements -
- Drain Fluid amylase (POD 1,3 \& 5) \& serum amylase
- Serum Procalcitonin, C-reactive protein and albumin (POD 5)
- Remnant pancreatic parenchymal thickness \& change in thickness at pancreaticojejunostomy site/splenoportal confluence on NCCT abdomen (POD 5)
- Presence \& location of intra-abdominal collection by NCCT abdomen (POD 5)
- Interventions required if any for management of complications
Statistical Analysis: Data will be entered into Excel Worksheet and statistical analyses will be performed by SPSS Statistics version 22 (IBM Corp., Armonk, NY). Statistical data will be represented as frequencies (%) where the continuous variables will be expressed as medians and interquartile range (IQR). Continuous variables will be compared with the student t test and Mann-Whitney test as appropriate. Differences between proportions derived from categorical data will be compared with Chi-square or Fischer's exact test. Variables will be correlated with clinical outcomes. ROC curve will be used for biochemical markers and imaging findings Repeated analyses of measures will be applied wherever applicable.
Adverse effects: None
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post whipple's procedure patients | – | Other: no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients undergoing pancreatoduodenectomy at ILBS
Key inclusion criteria (2 listed)
- Consecutive patients undergoing Pancreatoduodenectomy at ILBS
- Duct to mucosa pancreaticojejunostomy
Key exclusion criteria (7 listed)
- Refused for consent
- Age < 18 yrs
- Hepatopancreatoduodenectomy
- Multi-visceral resection
- Re-exploration before POD 5
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 | Other | Post whipple's procedure patients |
Primary outcome
change in pancreatic parenchymal thickness at pancreaticojejunostomy site/spleno-portal confluence on postoperative day 5 predicts the severity of postoperative pancreatic fistula after pancreatoduodenectomy in early postoperative period
Time frame: Post operative day 5
5 secondary outcomes
Levels of C-reactive protein among the different grades of post operative pancreatic fistula
Time frame: Post operative day 5
Levels of serum albumin among the different grades of postoperative pancreatic fistula.
Time frame: Post operative day 5
Levels of serum procalcitonin among the different grades of postoperative pancreatic fistula.
Time frame: Post operative day 5
Intra-abdominal collection among the different grades of postoperative pancreatic fistula by NCCT abdomen.
Time frame: Post operative day 5
Location of intra-abdominal collection among the different grades of postoperative pancreatic fistula by NCCT abdomen.
Time frame: Post operative day 5
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 7 May 2024.
- 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.
Dr Piyush Kumar Sinha, MCh study director
Institute of Liver and Biliary Sciences, New Delhi
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 Post Operative Pancreatic Fistula, 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 2 inclusion and 7 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 7 May 2024. 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?
change in pancreatic parenchymal thickness at pancreaticojejunostomy site/spleno-portal confluence on postoperative day 5 predicts the severity of postoperative pancreatic fistula after pancreatoduodenectomy in early postoperative period (time frame: Post operative day 5). 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 7 May 2024.