Abstract
BackgroundDistal pancreatectomy for benign and malignant tumours is the second most common surgical procedure on the pancreas. Postoperative pancreatic fistulas (POPF) represent the most significant clinical complication, causing prolongation of hospital stay and the need for additional diagnostic and therapeutic procedures. Although various techniques for preventing POPF have been evaluated, to date, there is no available technique that ensures closure of the pancreatic remnant.Methods/DesignDISCOVER will aim to investigate differences in the postoperative course after a distal pancreatectomy comparing the standard surgical technique with an alternative technique that provides additional coverage of the pancreatic remnant by the falciform ligament. The primary endpoint of this trial will be the rate of POPF. As secondary endpoints, incidence of postoperative morbidity and mortality, length of hospital stay, and quality of life will be assessed.DISCOVER is a single-centre, randomised, controlled surgical trial. For statistical analysis, a binary logistic regression model will be used. With a level of significance of 5% and a power of 80%, a sample size of 75 patients per group has been identified as necessary.DiscussionThe findings of this trial will help to evaluate the usefulness of the coverage procedure at reducing the rate of POPF. The results could influence the standard procedure for remnant closure after distal pancreatectomy.Trial-registrationClinical trials register (DRKS-ID: DRKS00000546)
Highlights
Distal pancreatectomy for benign and malignant tumours is the second most common surgical procedure on the pancreas
The findings of this trial will help to evaluate the usefulness of the coverage procedure at reducing the rate of Postoperative pancreatic fistulas (POPF)
The results could influence the standard procedure for remnant closure after distal pancreatectomy
Summary
Distal pancreatectomies are performed for benign or malignant tumours in most cases. Despite the increasing caseload, the morbidity associated with this kind of operation remains high, mainly due to POPF, which occur in up to 60% of patients [7]. It can be assumed that quality of life is considerably impaired in fistula patients. The DISCOVER trial will evaluate the technique of additional coverage of the pancreatic remnant and its effectiveness at reducing the rate of POPF after distal pancreatectomies. The thesis that quality of life is impaired by POPF will be tested by means of a validated questionnaire (EQ-5D questionnaire; EuroQol Group Foundation). If the use of the coverage procedure can be shown to reduce the rate of POPF, this would help to establish the coverage procedure as a standard technique after distal pancreatectomy. MWB and JW provided scientific input for the trial’s background and rationale. They defined the patient collective and the specifications of the study intervention.
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