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Completed

NCT Number: NCT05687825

Risk Factors for Clinically Relevant Postoperative Pancreatic Fistula

For periampullary and pancreatic head disorders, pancreaticoduodenectomy (PD) is the standard treatment. However, PD is technically demanding and has high morbidity and mortality rates. The most significant and life-threatening complication of PD is postoperative pancreatic fistula (POPF), with reported rates of 5 to 70% for total POPF and 10 to 45% for clinically relevant (CR-POPF). Operative risk variables for CR-POPF after PD were investigated in this study.

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Key information

Conditions

Pancreatic Fistula Digestive System Diseases Digestive System Fistula Fistula Pancreatic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Qena faculty of Medicine, South Valley University

Cairo, Egypt

About this study

For periampullary and pancreatic head disorders, pancreaticoduodenectomy (PD) is the standard treatment. However, PD is technically demanding and has high morbidity and mortality rates. The most significant and life-threatening complication of PD is postoperative pancreatic fistula (POPF), with reported rates of 5 to 70% for total POPF and 10 to 45% for clinically relevant (CR-POPF). Operative risk variables for CR-POPF after PD were investigated in this study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with resectable distal CBD carcinoma, periampullary carcinoma, duodenal carcinoma, and carcinoma of the head of the pancreas.
  • American Society of Anesthesiologists (ASA) scores I & II.
  • Patients aged > 20 years.
  • Agreement to complete the study.

Exclusion criteria

  • Patients with benign disease, trauma, and receive neoadjuvant therapy.
  • double primary cancers.

Treatment and study plan

pancreaticoduodenectomy procedure

Procedure

Pancreaticoduodenectomy operation

Primary outcomes

  1. clinically relevant post operative pancreatic fistula

    Time frame: 10 days

    A drainage fluid of any measurable volume with an amylase level more than three times the upper normal serum level on or after the 3rd postoperative day

Sponsors and collaborators

Lead sponsor

South Valley University

Other

Registry information

Official study title

Operative Risk Factors for Clinically Relevant Postoperative Pancreatic Fistula After Pancreaticoduodenectomy: A Prospective Multicenter Cohort Study

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jan 18, 2023
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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