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Study on Intraperitoneal Drainage After Pancreas Surgery

This study is looking at whether a drain (19 French Blake Intraperitoneal Drain) is truly needed after a type of pancreas surgery called a distal pancreatectomy. This surgery removes part of your pancreas, often for cysts or tumors. Researchers want to see if not using a drain, especially with new surgical stapling techniques, is just as safe as using one. They will compare groups based on complications like pancreatic fistula (a leak of digestive fluids), needing to be readmitted to the hospital, or infections at the surgical site within 90 days of your surgery. You may be able to join if you are 18 or older, are scheduled for a distal pancreatectomy, and can give informed consent. The study is currently unclear on its recruitment status and aims to enroll 234 participants.

Study design
This is an interventional study comparing two groups of participants undergoing distal pancreatectomy, one with and one without a drain. It aims to enroll 234 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for complications within 90 days of their surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05720338

Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy?

Recruiting
PHASE3Ages 18+InterventionalSupportive care
Case Comprehensive Cancer Center
~234 participants
Updated 2026-02-19 on ClinicalTrials.gov
What's tested:19 French Blake Drain

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Composite endpoint comparison
Measured over Within 90 days of surgery
+3 more outcomes measured

Conditions

Cyst of Pancreas
Pancreatectomy
Pancreas Neoplasm

Explore related trials

Pancreatic CystPancreatic Neoplasm

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Robert Simon, MD · PRINCIPAL_INVESTIGATOR · Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Who to contact

Robert Simon, MD
[email protected]
1-866-223-8100
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Subjects must be undergoing a scheduled distal pancreatectomy (with or without concurrent splenectomy)
Age ≥18 years
Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion

Patients \< 18 years old
Patients who are pregnant
Patients with a history of previous pancreatic surgery
Patients with a history of prior gastric resection, gastric bypass or sleeve gastrectomy
Patients with prior cystogastrostomy procedure
Patients who have failed prior endoscopic intervention or ultrasound due to esophageal or other gastrointestinal stricture
Patients with Type 3 or Type 4 Paraesophageal Hernia noted either on pre-operative imaging or intra-operatively
Patients undergoing concurrent resection of organs other than the pancreas or spleen or gallbladder
Patients who undergo oversewing of the pancreatic transection margin
Patients with unexpected intraoperative bleeding or adhesive disease which deem it unsafe to proceed without an intraabdominal drain
Patients who are unable to provide informed consent

What this trial measures

  • Composite endpoint comparisonWithin 90 days of surgery

    Comparison between groups using a composite endpoint of complications that includes presence of Grade B POPF

  • Composite endpoint comparisonWithin 90 days of surgery

    Comparison between groups using a composite endpoint of complications that includes presence of Grade C POPF

  • Composite endpoint comparisonWithin 90 days of surgery

    Comparison between groups using a composite endpoint of complications that includes Readmission

  • Composite endpoint comparisonWithin 90 days of surgery

    Comparison between groups using a composite endpoint of complications that includes presence of Organ Space Surgical Site Infection