Pancreaticoduodenectomy Clinical Trial
— DRAPAOfficial title:
Does the Type of Drain Influence the Postoperative Pancreatic Fistula Rate After Pancreatic Resection?
Verified date | January 2017 |
Source | University Hospital Hradec Kralove |
Contact | n/a |
Is FDA regulated | No |
Health authority | Czech Republic: Ethics Committee |
Study type | Interventional |
Pancreatic resection is the only potentially curative modality of treatment for pancreatic
neoplasm. The mortality associated with this procedure decreased rapidly in the past
decades. However, the morbidity associated with pancreatic resection remains high. The main
reason for postoperative morbidity is postoperative pancreatic fistula (POPF), which is
regarded as the most ominous complication following pancreatic resection. Its reported
incidence varies in the surgical literature from 10% to >30%.
Recently published studies showed that the placement of intraoperative drains, manipulation
with the drains, timing of removal of the drain, and especially the type of drain, have
significant effect on the postoperative complications, and especially POPF.
Controversy exists regarding the type of intraoperatively placed drain. Nowadays, the two
most commonly used systems are closed suction drainage and closed gravity drainage. Open
systems have been abandoned in most centers as they are obsolete.
Our hypothesis is that the closed suction drain will have better results as it is more
effective than the gravity drainage. However, some surgeons claim that the suction system
can actively suck the pancreatic juice through the anastomosis or suture and thus promote
the development of POPF.
The aim of this study is to compare closed suction drains and closed gravity drains after
pancreatic resection in a randomized controlled study.
The primary end-point is the postoperative pancreatic fistula rate. The secondary end-point
is the postoperative morbidity.
Status | Completed |
Enrollment | 223 |
Est. completion date | May 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
Inclusion Criteria: - pancreaticoduodenectomy - distal pancreatectomy Exclusion Criteria: - central pancreatectomy - total pancreatectomy - enucleation - laparoscopic procedure - resection and reconstruction of portal vein |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Czech Republic | Department of Surgery | Hradec Kralove | |
Czech Republic | Department of Surgery | Olomouc |
Lead Sponsor | Collaborator |
---|---|
University Hospital Hradec Kralove |
Czech Republic,
Cecka F, Lovecek M, Jon B, Skalický P, Ĺ ubrt Z, Ferko A. DRAPA trial--closed-suction drains versus closed gravity drains in pancreatic surgery: study protocol for a randomized controlled trial. Trials. 2015 May 7;16:207. doi: 10.1186/s13063-015-0706-1. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative pancreatic fistula | Postoperative pancreatic fistula defined according to the ISGPF (International Study Group for Pancreatic Fistula) | 30 days postoperatively | Yes |
Secondary | Postoperative morbidity | 30 days postoperatively | Yes |
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