Prophylactic Abdominal Drainage vs no Drainage After Distal Pancreatectomy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorClinica Universidad de Navarra, Universidad de Navarra
About this trial
Postoperative pancreatic fistula (POPF) is a major source of morbidity and mortality after pancreatic resection, especially after distal pancreatectomy (PD). Today, POPF remains one of the main causes of hospital length of stay and healthcare costs. Numerous surgical techniques have been tested to reduce its incidence without success, so the current standard for the management of POPF, and the avoidance of associated complications, is intraoperative drain placement. However, surgically placed drains are not without risk. In recent years many studies, mostly retrospective, have attempted to determine whether omission of prophylactic drainage is associated with increased morbidity. These studies suggest that patients may benefit from not having a drain placed. This evidence challenges standard practice and the debate of whether or not to place a drain after distal pancreatectomy remains open. The investigators designed a prospective multicentre randomised non-inferiority study to determine whether prophylactic intraoperative drainage is associated with a lower morbidity rate after distal pancreatectomy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (over 18 years of age) undergoing elective distal pancreatectomy surgery for any indication, with or without splenectomy, minimally invasive or open. It is not necessary to integrate gender perspective as it is not relevant and there is no influence on the results of POPF or morbidity.
Signed informed consent was obtained from each of the patients included in the study.
Disqualifiers
Patients undergoing distal pancreatectomy as a secondary procedure
Additional liver, gastric or colonic resection
Pregnancy
Participation in another study
Trial design
Design model
Parallel
Treatments tested in this trial
Avoid surgical drainage
Procedure/SurgeryPatients who undergo distal pancreatectomy, avoid placing a drain.
Treatment groups
104 Participants
are divided into 2 treatment groupsGroup A: DrainageNo intervention 0 interventions
Group B: No drainageExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Clinically relevant postoperative pancreatic fistula
The investigators define a clinically relevant pancreatic fistula following the 2016 update of the International Study Group (ISGPS) definition. According to this, a Clinically Relevant Postoperative Pancreatic Fistula refers to a grade B or C. Grade B requires a change in the postoperative management; drains are either left in place \>3 weeks or repositioned through endoscopic or percutaneous procedures. Grade C postoperative pancreatic fistula refers to those postoperative pancreatic fistula that require reoperation or lead to single or multiple organ failure and/or mortality attributable to the pancreatic fistula.
Time frame
From first postoperative day until day 30 after surgerySecondary outcomes
1
Clavien-Dindo morbidity greater than or equal to 3.
To evaluate postoperative morbidity (Clavien-Dindo 3 or higher complications) in patients who undergo distal pancreatectomy. Comparing between the two groups of patients if there are any differences due to the presence or absence of a drainage. According to the Clavien-Dindo classification: 3 - Requiring surgical, endoscopic or radiological intervention 3a-Intervention under regional/local anesthesia 3b- Intervention under general anesthesia 4 -Life-threatening complication requiring intensive care/intensive care unit management 4a- Single organ dysfunction 4b- Multi-organ dysfunction 5 - Patient demise
Time frame
From first postoperative day until the ninth month after surgery2
Reoperation.
To determine the rates of reoperation 90 days after distal pancreatectomy
Time frame
From first postoperative day until day 90 after surgery3
Percutaneous drainage.
To determine the rates of percutaneous drainage 90 days after distal pancreatectomy. The need for a percutaneous drainage procedure, using an endoscopic or radiological approach, for the treatment of postoperative pancreatic fistula.
Time frame
From first postoperative day until day 90 after surgery4
Abdominal collections
To determine the rate of abdominal collections 90 days after distal pancreatectomy. The investigators define an abdominal collection as a presence of liquid in the abdomen that cause symptoms in the patient, such as fever, and that may require less invasive therapeutic agents and treatment or percutaneous, endoscopic or angiographic interventional procedures.
Time frame
From first postoperative day until day 90 after surgeryLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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