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Buttressed Pancreatico-Gastrostomy for Soft Pancreas With Small Diameter Pancreatic Duct in Whipple Procedure

Sponsor
South Valley University (Other)
Overall Status
Completed
CT.gov ID
NCT05682768
Collaborator
(none)
69
Enrollment
1
Location
59.8
Actual Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Post-operative pancreatic fistula after Pancreaticoduodenectomy procedure, is still a major complication that might be affected by pancreatic stump reconstruction technique. More than 60 techniques were published in literature. Soft pancreas and small pancreatic duct size were major risk factors for post-operative pancreatic fistula. Supporting Duct to Mucosa Pancreatico-Gastrostomy with trans-pancreatic transverse mattress U- Shaped sutures is a new and safe technique for decreasing the risk of post-operative pancreatic fistula in high-risk patients.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Duct to Mucosa Pancreatico-Gastrostomy with trans-pancreatic transverse mattress U- Shaped sutures

Detailed Description

Post-operative pancreatic fistula after Pancreaticoduodenectomy procedure, is still a major complication that might be affected by pancreatic stump reconstruction technique. More than 60 techniques were published in literature. Soft pancreas and small pancreatic duct size were major risk factors for post-operative pancreatic fistula. Supporting Duct to Mucosa Pancreatico-Gastrostomy with trans-pancreatic transverse mattress U- Shaped sutures is a new and safe technique for decreasing the risk of post-operative pancreatic fistula in high-risk patients.

The authors used this technique in pancreato-gastrostomy. Data were collected, tabulated and analyzed to evaluate the new technique and its impact on the incidence of post-operative pancreatic fistula.

Study Design

Study Type:
Observational
Actual Enrollment :
69 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Buttressed Pancreatico-Gastrostomy for Soft Pancreas With Small Pancreatic Duct Diameter in Whipple Procedure. A Retrospective Cohort Study
Actual Study Start Date :
Jan 1, 2018
Actual Primary Completion Date :
Nov 30, 2022
Actual Study Completion Date :
Dec 25, 2022

Arms and Interventions

Arm Intervention/Treatment
Patients

Patients with cancer pancreas with soft pancreas and non-dilated pancreatic duct

Procedure: Duct to Mucosa Pancreatico-Gastrostomy with trans-pancreatic transverse mattress U- Shaped sutures
Adding suporting sutures between th posterior gastric wall and ancreatic stump in whipple procedure, the sutures are Duct to Mucosa Pancreatico-Gastrostomy with trans-pancreatic transverse mattress U- Shaped sutures.
Other Names:
  • Buttressing sutures

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Post operative Pancreatic Fistula [up to 5 days (from time of surgery to time of detection of post-operative pancreatic fistula)]

      Detection of chemical or clinical pancreatic fluid discharge after post-operative day 3.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patient diagnosed with resectable cancer head pancreas.

    • Soft Pancreas.

    • Small pancreatic duct diameter.

    Exclusion Criteria:

    • Unresectable cancer pancreas.

    • Non soft pancreas.

    • Dilated pancreatic duct.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Qena Faculty of Medicine, South Valley University Hospitals Qinā Egypt

    Sponsors and Collaborators

    • South Valley University

    Investigators

    • Principal Investigator: Abdallah M Taha, MD, South Valley University, Faculty of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Abdallah Mohamed Taha Aly, Assistant Professor, South Valley University
    ClinicalTrials.gov Identifier:
    NCT05682768
    Other Study ID Numbers:
    • SVU-MED-SUR011-4-22-10-465
    First Posted:
    Jan 12, 2023
    Last Update Posted:
    Jan 12, 2023
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Abdallah Mohamed Taha Aly, Assistant Professor, South Valley University
    Cancer pancreas
    Pancreaticoduodenectomy
    Pancreaticogastrostomy
    Additional relevant MeSH terms:
    Pancreatic Fistula
    Fistula

    Study Results

    No Results Posted as of Jan 12, 2023