NCT05720338 Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy?
| NCT ID | NCT05720338 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Case Comprehensive Cancer Center |
| Condition | Cyst of Pancreas |
| Study Type | INTERVENTIONAL |
| Enrollment | 234 participants |
| Start Date | 2023-04-13 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 234 participants in total. It began in 2023-04-13 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Robert Simon, MD
PRINCIPAL INVESTIGATOR
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT05720338 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cyst of Pancreas. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05720338 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 234 participants.
Is NCT05720338 currently recruiting?
Yes, NCT05720338 is actively recruiting participants. Contact the research team at TaussigResearch@ccf.org for enrollment information.
Where is the NCT05720338 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT05720338 clinical trial?
NCT05720338 is sponsored by Case Comprehensive Cancer Center. The principal investigator is Robert Simon, MD at Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center. The trial plans to enroll 234 participants.