Evaluating the need for drainage after distal pancreatectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates whether routine intraperitoneal drainage is necessary after a distal pancreatectomy, particularly in patients using reinforced staple technology. The study aims to compare outcomes between patients who receive drainage and those who do not, focusing on complications such as postoperative pancreatic fistula, readmission rates, and surgical site infections. By analyzing these outcomes, the trial seeks to determine if omitting drainage is non-inferior to the traditional approach. The findings could potentially influence surgical practices and improve patient recovery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Robert Simon, MD — Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
• Study coordinator: Robert Simon, MD
• Email: TaussigResearch@ccf.org
• Phone: 1-866-223-8100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.