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Understanding Different Levels of Leakage and Recovery Problems After Pancreas Surgery

POPF Escalation Phenotypes: A Novel Classification System and Mortality Prediction Index for Clinically Relevant Postoperative Pancreatic Fistula Following Pancreaticoduodenectomy - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/05/111165
Enrollment
423
Registered
2026-05-26
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K869- Disease of pancreas, unspecified

Interventions

Intervention1: Nil: Nil

Sponsors

Tata Memorial Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients who underwent pancreaticoduodenectomy (classical or pylorus-preserving) at Tata Memorial Centre between January 2013 and December 2024 Development of clinically relevant postoperative pancreatic fistula (ISGPS Grade B or C)

Exclusion criteria

Exclusion criteria: Total pancreatectomy, distal pancreatectomy, or central pancreatectomy Incomplete follow-up data Death within 48 hours of surgery (precluding phenotype classification)

Design outcomes

Primary

MeasureTime frame
90 day all cause mortality following pancreaticoduodenectomy in patients with clinically relevant POPF (Grade B or C).Timepoint: 90 day after surgery—

Secondary

MeasureTime frame
POPF Escalation Phenotype (PEP) distribution at day-14 landmark assessment Phenotype-specific mortality rates with 95% confidence intervals Time to phenotype escalation from POPF diagnosis ICU admission rate & duration Peak SOFA scores across phenotypes Rates of organ failure (respiratory, renal, cardiovascular) Rates of reoperation & completion pancreatectomy Hospital length of stay PMPI discrimination (AUROC) & calibration Timepoint: Baseline day of surgery postoperative day 14 during hospital stay at discharge & up to 90 days after surgery—

Countries

India

Contacts

Public ContactDr Vikram Chaudhari

Tata Memorial Hospital

drvikramchaudhari@gmail.com9869697799

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026