Risk Factors for Clinically Relevant Postoperative Pancreatic Fistula

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

107 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-01

Study Completion Date

2022-07-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pancreatic Fistula

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Clinically relevant postoperative pancreatic fistula

patients who developed clinically relevant postoperative pancreatic fistula after pancreaticoduodenectomy

pancreaticoduodenectomy procedure

Intervention Type PROCEDURE

Pancreaticoduodenectomy operation

No clinically relevant postoperative pancreatic fistula

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

pancreaticoduodenectomy procedure

Intervention Type PROCEDURE

Pancreaticoduodenectomy operation

Interventions

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pancreaticoduodenectomy procedure

Pancreaticoduodenectomy operation

Intervention Type PROCEDURE

Eligibility Criteria

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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.