Predictors of Severity of Postoperative Pancreatic Fistula After Pancreatoduodenectomy
1 other identifier
observational
50
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2022
CompletedFirst Posted
Study publicly available on registry
March 23, 2022
CompletedStudy Start
First participant enrolled
April 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 3, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 5, 2024
CompletedMay 7, 2024
October 1, 2023
1.9 years
March 14, 2022
May 6, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
Post operative day 5
Secondary Outcomes (5)
Levels of C-reactive protein among the different grades of post operative pancreatic fistula
Post operative day 5
Levels of serum albumin among the different grades of postoperative pancreatic fistula.
Post operative day 5
Levels of serum procalcitonin among the different grades of postoperative pancreatic fistula.
Post operative day 5
Intra-abdominal collection among the different grades of postoperative pancreatic fistula by NCCT abdomen.
Post operative day 5
Location of intra-abdominal collection among the different grades of postoperative pancreatic fistula by NCCT abdomen.
Post operative day 5
Study Arms (1)
Post whipple's procedure patients
Interventions
Eligibility Criteria
Consecutive patients undergoing pancreatoduodenectomy at ILBS
You may qualify if:
- Consecutive patients undergoing Pancreatoduodenectomy at ILBS
- Duct to mucosa pancreaticojejunostomy
You may not qualify if:
- Refused for consent
- Age \< 18 yrs
- Hepatopancreatoduodenectomy
- Multi-visceral resection
- Re-exploration before POD 5
- Pancreaticogastrostomy
- Dunking type of pancreaticojejunostomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070, India
Study Officials
- STUDY DIRECTOR
Dr Piyush Kumar Sinha, MCh
Institute of Liver and Biliary Sciences, New Delhi
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2022
First Posted
March 23, 2022
Study Start
April 16, 2022
Primary Completion
March 3, 2024
Study Completion
March 5, 2024
Last Updated
May 7, 2024
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share