Evaluation of Sun's Scoring System Use in Post-pancraticodoudenectomy Pancreatic Fistula

Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID

Study Details

Study Description

Brief Summary

Evaluation of sun scoring system for predication of pancreatic fistula after Pancreaticoduodenectomy to facilitate timely intervention after Pancreaticoduodenectomy.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Pancreaticoduodenectomy is the only option curative intended in the treatment of resectable pancreatic ductal adenocarcinomas, duodenal carcinoma, ampullary carcinoma, lower common bile duct cholangiocarcinoma,. It is still associated with very high morbidity and mortality. [1]. Pancreatic cancer ranks as the seventh leading cause of cancer-related death worldwide, and the fourth among other cancers[2,3]. Pancreatic fistula(PF) is one of the most important complications after Pancreaticoduodenectomy, with an incidence of about 10% to 28%.[4].There are multiple risk factors for the predication of development of pancreatic fistula after pancreaticoduodenectomy which include soft gland texture, non-pancreatic cancer non-chronic pancreatitis pathology, small pancreatic duct diameter (<3 mm), and high intraoperative blood loss (>1000 mL) , excess intraoperative fluid administration and increased pancreatic parenchymal remnant volume [5,6,7]. Other reported risk factors as increased body mass index (BMI), poor preoperative nutrition, and male gender which preoperative may lead to pancreatic fistula [8.9]. Recent studies are deficient in evaluation and predication of pancreatic fistula . So the interest of our study to evaluate and predicate the risk factors and management of pancreatic fistula after Pancreaticoduodenectomy .

    Study Design

    Study Type:
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Time Perspective:
    Official Title:
    Evaluation of Sun's Scoring System Use in Post-pancraticodoudenectomy Pancreatic Fistula; an Observational Cohort Study.
    Anticipated Study Start Date :
    Jan 1, 2023
    Anticipated Primary Completion Date :
    Jan 1, 2025
    Anticipated Study Completion Date :
    Mar 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. predication of pancreatic fistula after Pancreaticoduodenectomy to facilitate timely intervention after Pancreaticoduodenectomy [Baseline]

      Early prediction of pancreatic fistula post PD facilities threraputic intervention and life saving in some cases

    Secondary Outcome Measures

    1. Reduce the morbidity and mortality and improve the quality after pancraticoduodenectomy [Baseline]

      Management of pancreatic fistula post PD improve quality of life

    Eligibility Criteria


    Ages Eligible for Study:
    25 Years to 70 Years
    Sexes Eligible for Study:
    Inclusion Criteria:
    • All the cases indicated for Pancreaticoduedenectomy with :
    1. age less than 70 years.

    2. resectable tumour,

    3. fitness patients

    Exclusion Criteria:
    • 1_patients with jaundice with serum bilirubin above 200mml/dl. 2_patients with bleeding tendency until corrected. 3_patients with advanced and metastatic malignancy. 4_patients with cardiopulmonary diseases.

    Contacts and Locations


    No locations specified.

    Sponsors and Collaborators

    • Assiut University


    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information


    Responsible Party:
    Mahmoud Saber Mekhemer, Evaluation of Sun's scoring system use in post-pancraticodoudenectomy pancreatic fistula; an observational cohort study, Assiut University
    ClinicalTrials.gov Identifier:
    Other Study ID Numbers:
    • Pancreatic fistula post PD
    First Posted:
    Dec 16, 2022
    Last Update Posted:
    Dec 16, 2022
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 16, 2022