- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01988519
Randomized Controlled Trial Comparing Closed-suction Drain Versus Passive Gravity Drain Following Pancreatic Resection (DRAPA)
Does the Type of Drain Influence the Postoperative Pancreatic Fistula Rate After Pancreatic Resection?
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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, 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.
Even though several trials showed that the routine use of intraoperatively placed drains in elective pancreatectomy does not reduce postoperative morbidity, most of the high-volume pancreatic surgery centers still place the drains routinely. The theoretical advantage of drainage is to identify an early bile or pancreatic leak, or postoperative hemorrhage; and therefore allow for early treatment of the complication; or in some cases, the drain would control the leak without necessity of reintervention.
Two large studies compared early versus late removal of the intraoperatively placed drains. The first published by Kawai et al. was a cohort study, including 104 patients. The second one published by Bassi et al. was prospective randomized trial including 114 patients. Both studies clearly showed that the group of patients with early drain removal has superior results, lower rate of POPF and lower morbidity.
Controversy exists regarding the type of intraoperatively placed drain. The surgeons in the USA usually use the closed suction drainage system. On the other hand, European and Asian surgeons usually prefer open Penrose system, closed gravity drainage, or a combination of both. The closed suction drainage system uses slight under pressure to drain the fluid from the abdominal cavity. It is more effective than other systems, and thus advantageous. 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.
Only one study published by Schmidt et al. compared closed suction drainage system with gravity drainage. However, this study collected results over a very long period, and the comparison of the drains was not primary end-point of the study. Randomized controlled trials comparing various drains were published in cardiac surgery.
The situation in pancreatic surgery is specific. The pancreatic anastomosis or suture line is not water-tight in large proportion of cases. It is due to the character of pancreatic parenchyma. Especially in soft pancreas, the stitches can cut through and cause leak of the suture line or anastomosis. Therefore, pancreatic leak is not rare after pancreatic resections. Most of the POPF are grade A according to the ISGPF classification; with no clinical consequences. The aim of the postoperative management should prevent the POPF become clinically more severe (grade B and C). And the manipulation with the drains, and especially the type of drain, seem to play a major role.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hradec Kralove, Czech Republic, 50005
- Department of Surgery
-
Olomouc, Czech Republic, 77900
- Department of Surgery
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- pancreaticoduodenectomy
- distal pancreatectomy
Exclusion Criteria:
- central pancreatectomy
- total pancreatectomy
- enucleation
- laparoscopic procedure
- resection and reconstruction of portal vein
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Closed suction drain
Two closed suctions drains will be placed near the pancreatic anastomosis or suture line.
The drains will be removed on the 4th or 5th day if the amylase activity is not increased.
|
BLAKE Silicon drains (Ethicon, USA)
|
Active Comparator: Closed gravity drain
Two closed gravity drains will be placed near the pancreatic anastomosis or suture line.
The drains will be removed on the 4th or 5th day if the amylase activity is not increased.
|
passive tube drains (PFM Medical, Köln, Germany)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative pancreatic fistula
Time Frame: 30 days postoperatively
|
Postoperative pancreatic fistula defined according to the ISGPF (International Study Group for Pancreatic Fistula)
|
30 days postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Postoperative morbidity
Time Frame: 30 days postoperatively
|
30 days postoperatively
|
Collaborators and Investigators
Investigators
- Principal Investigator: Filip Cecka, MD, PhD, Department of Surgery, University Hospital Hradec Kralove
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FNHK 13
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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