Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy?

Conditions

• Cyst of Pancreas
• Pancreas Neoplasm
• Pancreatectomy

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 19 French Blake Drain — DEVICE
  19 French Blake Intraperitoneal Drain will be placed near the pancreatic resection margin

Study Details

The goal of this clinical trial is to analyze if intraperitoneal drainage is necessary following distal pancreatectomy. This study aims to determine whether the omission of routine intraperitoneal drainage in the setting of reinforced staple technology is non-inferior to routine intraperitoneal drainage with respect to a composite post-operative complications of Grade B or C Postoperative pancreatic fistula (POPF), readmission, or organ space surgical site infection following a distal pancreatectomy.

Key Dates

Start date

Apr 13, 2023

Status verified

Feb 2026

Primary completion

Dec 31, 2026

Completion

Jul 31, 2027

Study Design

Enrollment

234 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Active Comparator: Standard of care
  Intraperitoneal drain will be placed near the pancreatic resection margin, which is the routine standard of care.
• No Intervention: Omitting Standard of Care
  No intraperitoneal drain will be placed in the participants, which omits the routine standard of care.

Primary Outcome Measure

Composite endpoint comparison [ Time Frame: Within 90 days of surgery ]

Central Contacts

• Robert Simon, MD
  1-866-223-8100
  [email protected]

Locations (1)

Find similar trials in Cleveland, OH

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