Postoperative Pancreatic Fistula Following Pancreaticoduodenectomy

September 27, 2026 updated by: Omar Anter Ali Abdelhamid, Assiut University

Development and Internal Validation of a Preoperative Risk Model for Clinically Relevant Postoperative Pancreatic Fistula Following Pancreaticoduodenectomy

Postoperative pancreatic fistula (POPF) especially clinically relevant POPF (CR-POPF; Grades B and C) is one of the critical and challenging post pancreaticoduodenectomy complications. Despite advances in surgical techniques, perioperative care, and centralization of pancreatic surgery Postoperative pancreatic fistula (POPF) remains an important cause for postoperative morbidity and

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Several risk prediction models have been developed to estimate the likelihood of CR-POPF, including the Fistula Risk Score (FRS), the Alternative Fistula Risk Score (a-FRS) and updated alternative Fistula Risk Score (ua-FRS). However, these models rely predominantly on intraoperative variables, such as pancreatic texture and main pancreatic duct diameter, limiting their value in preoperative risk stratification and patient counselling .

Despite the robustness of these scoring systems, certain aspects require further refinement. In particular, assessment of pancreatic texture remains largely subjective and dependent on intraoperative surgeon palpation, highlighting the need for more objective and quantitative methods. [3,4] Furthermore, elastography has emerged as a promising non-invasive technique for quantitative characterization of pancreatic tissue stiffness and has recently been investigated for preoperative prediction of clinically relevant postoperative pancreatic fistula; however, it has not yet been incorporated into the widely used fistula risk scoring systems.

Onodera's prognostic nutritional index (PNI) is calculated from serum albumin concentration and peripheral blood lymphocyte (PBL) count. It indicates the patient's nutritional and immunological status and is used to predict risk of several kinds of complications after surgery. Moreover, several preoperative nomograms and machine-learning models have demonstrated promising predictive performance for POPF. However, PNI has not been included in any of these scores.

Given the absence of an internally validated preoperative prediction model in the Egyptian population, this study aims to develop and internally validate a preoperative risk model for clinically relevant postoperative pancreatic fistula by incorporation of preoperative PNI and pancreatic texture assessment by elastography with previously emerged scores in patients undergoing pancreaticoduodenectomy. The proposed model may facilitate individualized risk stratification, optimize perioperative planning, improve patient counselling, and support evidence-based surgical decision-making

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hisham Ali Riad Shaban Ali Riad Hisham Ali Riad Shaban, Professor of General Surgery
  • Phone Number: 01005015757
  • Email: heshamreyad@aun.edu.eg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing elective pancreaticoduodenctomy

Description

Inclusion Criteria:

  • Adults (≥18 years).
  • Elective pancreaticoduodenectomy.
  • Benign or malignant periampullary and pancreatic lesions.

Exclusion Criteria:

  • - Total pancreatectomy.
  • Distal pancreatectomy.
  • Missing essential preoperative data.
  • Death within 24 hours after surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
preoperative risk model for clinically relevant postoperative pancreatic fistula
Procedure: pancreaticoduodenectomy

preoperative risk model for clinically relevant postoperative pancreatic fistula by incorporation of preoperative PNI and pancreatic texture assessment by elastography with previously emerged scores in patients undergoing pancreaticoduodenectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of clinically relevant postoperative pancreatic fistula
Time Frame: Within 90 days after surgery

Proportion of patients developing clinically relevant postoperative pancreatic fistula (Grade B or C) following pancreaticoduodenectomy, according to the International Study Group of Pancreatic Surgery (ISGPS) definition.
Within 90 days after surgery
Discrimination of the preoperative prediction model
Time Frame: Within 90 days after surgery

Area under the receiver operating characteristic curve (AUROC) for the preoperative prediction model in predicting clinically relevant postoperative pancreatic fistula.
Within 90 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 30, 2026

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

December 30, 2028

Study Registration Dates

First Submitted

September 16, 2026

First Submitted That Met QC Criteria

September 27, 2026

First Posted (Actual)

October 2, 2026

Study Record Updates

Last Update Posted (Actual)

October 2, 2026

Last Update Submitted That Met QC Criteria

September 27, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fistula Risk Score

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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