Post-operative Drainage After Pancreaticoduodenectomy (Drain 1)

Linköping University (LiU)

Status: Enrolling

Conditions: Pancreatic Cancer

Treatments: Procedure: Drain; Procedure: No drain

Study type: Interventional

Funder types: Other

Identifiers

NCT05270564

Drain_1

Details and patient eligibility

About

The study compares regular use of surgical drains and no use of surgical drains in patients subjected to pancreaticoduodenectomy with expected low to intermediate risk for post operative pancreatic fistula.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing pancreaticoduodenectomy of both sexes
• Patients with predicted risk score of 10 or less of pancreatic fistula
• Written informed consent
• Expected survival time > 6 months

Exclusion criteria

• Patients with predicted high risk of fistula with a risk score above 10
• Patients with intraabdominal abscess or infection
• ASA score > 3
• Pregnancy
• Expected lack of compliance

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Drain

Active Comparator group

Description:

Surgical drains used as routine

Treatment:

Procedure: Drain

No drain

Experimental group

Description:

No surgical drain used

Treatment:

Procedure: No drain