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External validation of ISGPS two-factor, four-tier classification for the prediction of pancreatic fistula after pancreaticoduodenectomy

External validation of ISGPS two-factor, four-tier classification for the prediction of pancreatic fistula after pancreaticoduodenectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
TCTR
Registry ID
TCTR20250722004
Enrollment
500
Registered
2025-07-22
Start date
2025-03-03
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Postoperative Pancreatic Fistula (POPF): The primary condition studied is the occurrence of clinically relevant pancreatic fistula following pancreaticoduodenectomy (also known as the Whipple procedure). Secondary Surgery-Related Complications: The study also assesses complications directly attributable to POPF, including: Delayed gastric emptying (DGE) Postpancreatectomy hemorrhage (PPH) Intra-abdominal collections and abscess formation Re-exploration after surgery 90-day postoper

Interventions

The observation group consisted of 591 consecutive patients who underwent pancreatoduodenectomy for periampullary and pancreatic head pathologies between January 2009 and December 2024. Patients with
Health Services Research
pancreatoduodenectomy group

Sponsors

Institute of Postgraduate Medical Education and Research, Kolkata
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Undergoing pancreaticoduodenectomy for periampullary or pancreatic head pathology

Exclusion criteria

Exclusion criteria: Exclusion of palliative surgeries

Design outcomes

Primary

MeasureTime frame
POPF Within 30 days postoperatively Diagnosis of postoperative pancreatic fistula (POPF) according to the 2016 ISGPS clinical criteria

Secondary

MeasureTime frame
postoperative hospital stay From date of surgery to hospital discharge Length of postoperative hospital stay in days, as recorded in patient records

Countries

India

Contacts

Public ContactSukanta Ray

Institute of Postgraduate Medical Education and Research

drsukantaray@yahoo.co.in9830287364

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026