Risk Factors for Clinically Relevant Postoperative Pancreatic Fistula

South Valley University

Status: Completed

Conditions: Pancreatic Fistula

Treatments: Procedure: pancreaticoduodenectomy procedure

Study type: Observational

Funder types: Other

Identifiers

NCT05687825

SVU/MED/SUR011/4/23/4/612

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 107 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

107 participants in 2 patient groups

Clinically relevant postoperative pancreatic fistula

Description:

patients who developed clinically relevant postoperative pancreatic fistula after pancreaticoduodenectomy

Treatment:

Procedure: pancreaticoduodenectomy procedure

No clinically relevant postoperative pancreatic fistula

Description:

patients who did not develop clinically relevant postoperative pancreatic fistula after pancreaticoduodenectomy

Treatment:

Procedure: pancreaticoduodenectomy procedure