NCT01988519

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
223

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 13, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 20, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

January 10, 2017

Status Verified

January 1, 2017

Enrollment Period

2.6 years

First QC Date

November 13, 2013

Last Update Submit

January 6, 2017

Conditions

PancreaticoduodenectomyDistal Pancreatectomy

Outcome Measures

Primary Outcomes (1)

  • Postoperative pancreatic fistula

    Postoperative pancreatic fistula defined according to the ISGPF (International Study Group for Pancreatic Fistula)

    30 days postoperatively

Secondary Outcomes (1)

  • Postoperative morbidity

    30 days postoperatively

Study Arms (2)

Closed suction drain

ACTIVE COMPARATOR

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.

Procedure: closed suction drain

Closed gravity drain

ACTIVE COMPARATOR

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.

Procedure: Closed gravity drain

Interventions

Closed gravity drainPROCEDURE

passive tube drains (PFM Medical, Köln, Germany)

Closed gravity drain
closed suction drainPROCEDURE

BLAKE Silicon drains (Ethicon, USA)

Closed suction drain

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • pancreaticoduodenectomy
  • distal pancreatectomy

You may not qualify if:

  • central pancreatectomy
  • total pancreatectomy
  • enucleation
  • laparoscopic procedure
  • resection and reconstruction of portal vein

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Surgery

Hradec Králové, 50005, Czechia

Location

Department of Surgery

Olomouc, 77900, Czechia

Location

Related Publications (1)

  • Cecka F, Lovecek M, Jon B, Skalicky P, Subrt 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.

    PMID: 25947117BACKGROUND

Study Officials

  • Filip Cecka, MD, PhD

    Department of Surgery, University Hospital Hradec Kralove

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MUDr. Filip Čečka, Ph.D.

Study Record Dates

First Submitted

November 13, 2013

First Posted

November 20, 2013

Study Start

October 1, 2013

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

January 10, 2017

Record last verified: 2017-01

Locations

CZ(2)