Evaluating the need for drainage after distal pancreatectomy
Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy: A Randomized Control Trial
This study is testing if patients who have part of their pancreas removed really need drainage tubes afterward, especially when a special stapling method is used, to see if skipping the drainage leads to the same or better recovery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 234 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Case Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05720338 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for a distal pancreatectomy.
Not a fit: Patients with a history of previous pancreatic surgery or those undergoing concurrent organ resections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to reduced complications and improved recovery times for patients undergoing distal pancreatectomy.
How similar studies have performed: Previous studies have explored various strategies to prevent complications after pancreatic surgery, but this specific approach regarding drainage omission is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Cleveland, Ohio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.