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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
19 French Blake Drain
Device19 French Blake Intraperitoneal Drain will be placed near the pancreatic resection margin
Treatment groups
234 Participants
are divided into 2 treatment groupsGroup A: Standard of careActive comparator 1 intervention
Group B: Omitting Standard of CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Composite endpoint comparison
Comparison between groups using a composite endpoint of complications that includes presence of Grade B POPF
Time frame
Within 90 days of surgery2
Composite endpoint comparison
Comparison between groups using a composite endpoint of complications that includes presence of Grade C POPF
Time frame
Within 90 days of surgery3
Composite endpoint comparison
Comparison between groups using a composite endpoint of complications that includes Readmission
Time frame
Within 90 days of surgery4
Composite endpoint comparison
Comparison between groups using a composite endpoint of complications that includes presence of Organ Space Surgical Site Infection
Time frame
Within 90 days of surgerySecondary outcomes
1
Rates of endoscopic drainage vs percutaneous drainage of Grade B POPF
Rates of drainage based off of the Grade B Postoperative pancreatic fistula
Time frame
90-day post operative time point2
Quality of Life Score
Post-operative Quality of Life score using the PROMIS-10 Global Health
Time frame
At day 14 postoperative3
Quality of Life Score
Post-operative Quality of Life score using the PROMIS-10 Physical Function
Time frame
At day 14 postoperative4
Quality of Life Score
Post-operative Quality of Life score using the original Drain Quality of Life scale
Time frame
At day 14 postoperativeSponsors and contacts
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Source ClinicalTrials.gov