Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy?

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.

Interventions

• 19 French Blake Drain · DEVICE

  19 French Blake Intraperitoneal Drain will be placed near the pancreatic resection margin

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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

Sites (1)

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