A Phase 3 Randomized Trial to Evaluate the Need for Intraperitoneal Drainage After Distal Pancreatectomy Using Reinforced Staple Technology

What this Trial Is About

Researchers are evaluating whether routine intraperitoneal drainage is necessary after distal pancreatectomy, a common surgery for tumors in the pancreas body or tail. This trial focuses on comparing outcomes related to postoperative complications including pancreatic fistula, readmission, and surgical site infections. It aims to determine if omitting drainage is not worse than using drainage when reinforced staple technology is applied. Participants will be randomly assigned to one of two groups one receiving a 19 French Blake intraperitoneal drain placed near the pancreatic resection margin as the current standard of care, and the other not receiving any drain. The study monitors patients for complications and recovery following surgery to assess the safety and impact of omitting routine drainage. During the 90 days after surgery, researchers will track a composite of postoperative complications including pancreatic fistula grades, infections, and readmissions. Quality of life scores will be measured at 14 and 90 days postoperatively, along with hospital length of stay and healthcare costs. Participants will undergo regular assessments to monitor these outcomes and ensure safety throughout their recovery.

Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy?