NCT05720338RecruitingPhase 3
Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy?
Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy: A Randomized Control Trial
Source: ClinicalTrials.gov · Last updated 15 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 234 (estimated)
- First submitted
- 27 Jan 2023
- Start date
- 13 Apr 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Case Comprehensive Cancer Center
- Diseases
- Pancreatic cancer
- NCT number
- NCT05720338
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 234
- From 13 Apr 2023 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 undergoing concurrent resection of organs other than the pancreas or spleen or gallbladder
Other illness
- Patients with unexpected intraoperative bleeding or adhesive disease which deem it unsafe to proceed without an intraabdominal drain
Age
- Patients \< 18 years old
Other
- Patients who are pregnant
- Patients with Type 3 or Type 4 Paraesophageal Hernia noted either on pre-operative imaging or intra-operatively
- Patients who undergo oversewing of the pancreatic transection margin
- Patients who are unable to provide informed consent
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.