PancreaticoduodenectomyDRAPANCT01988519
Randomized Controlled Trial Comparing Closed-suction Drain Versus Passive Gravity Drain Following Pancreatic Resection
A study testing Closed gravity drain and closed suction drain in people with Pancreaticoduodenectomy and Distal Pancreatectomy, run by University Hospital Hradec Kralove at 2 sites in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pancreaticoduodenectomy, Distal Pancreatectomy
- What is being tested?
- Closed gravity drain and closed suction drain
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- 2 sitesCzechia
- Study dates
- Oct 2013to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pancreaticoduodenectomy
- distal pancreatectomy
Who cannot join
- central pancreatectomy
- total pancreatectomy
- enucleation
- laparoscopic procedure
- resection and reconstruction of portal vein
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites
Department of Surgery
Hradec Králové, 50005
Department of Surgery
Olomouc, 77900
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Pancreaticoduodenectomy, Distal Pancreatectomy
- Being tested
- Closed gravity drain, closed suction drain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed gravity drainProcedure or surgery
passive tube drains (PFM Medical, Köln, Germany)
closed suction drainProcedure or surgery
BLAKE Silicon drains (Ethicon, USA)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Closed gravity drain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pancreatic fistula
Postoperative pancreatic fistula defined according to the ISGPF (International Study Group for Pancreatic Fistula)
Measured: 30 days postoperatively
Secondary outcomes (1)
Postoperative morbidity
Measured: 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PancreaticoduodenectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Hradec Kralove
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filip Cecka, University Hospital Hradec Kralove
- Investigators
- Filip Cecka, MD, PhD, Principal investigator, Department of Surgery, University Hospital Hradec Kralove
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01988519
- Sponsor's protocol ID
- FNHK 13
- Acronym
- DRAPA
- Status last verified
- Jan 2017
- First submitted
- 13 Nov 2013
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25947117
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Type of Drain Influence the Postoperative Pancreatic Fistula Rate After Pancreatic Resection?
- ClinicalTrials.gov ID
- NCT01988519
- Acronym / sponsor ID
- DRAPA / FNHK 13
- Conditions
- Pancreaticoduodenectomy, Distal Pancreatectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- University Hospital Hradec KraloveUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 20 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closed suction drain | Active comparator | Procedure: closed suction drainTwo 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. |
| Closed gravity drain | Active comparator | Procedure: Closed gravity drainTwo 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- pancreaticoduodenectomy
- distal pancreatectomy
Key exclusion criteria (5 listed)
- central pancreatectomy
- total pancreatectomy
- enucleation
- laparoscopic procedure
- resection and reconstruction of portal vein
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Closed gravity drainpassive tube drains (PFM Medical, Köln, Germany) | Procedure or surgery | Closed gravity drain |
| closed suction drainBLAKE Silicon drains (Ethicon, USA) | Procedure or surgery | Closed suction drain |
Primary outcome
Postoperative pancreatic fistula
Time frame: 30 days postoperatively
Postoperative pancreatic fistula defined according to the ISGPF (International Study Group for Pancreatic Fistula)
1 secondary outcome
Postoperative morbidity
Time frame: 30 days postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2017.
- Background: PubMed 25947117Cecka 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Filip Cecka, MD, PhD principal investigator
Department of Surgery, University Hospital Hradec Kralove
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed gravity drain and closed suction drain in people with Pancreaticoduodenectomy and Distal Pancreatectomy, run by University Hospital Hradec Kralove at 2 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pancreatic fistula (time frame: 30 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01988519, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2017.