Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy?
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCase Comprehensive Cancer Center
About this trial
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
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- 19 French Blake Drain
Treatment groups
234 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov