Pancreatic CancerDrain 1NCT05270564
Post-operative Drainage After Pancreaticoduodenectomy
A study testing Drain and No drain in people with Pancreatic Cancer, run by Linkoeping University at 2 sites in Sweden.
Trial summary
The study compares regular use of surgical drains and no use of surgical drains in patients subjected to pancreaticoduodenectomy with expected low to intermediate risk for post operative pancreatic fistula. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Drain and No drain
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesSweden
- Study dates
- 1 May 2016to 31 Mar 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing pancreaticoduodenectomy of both sexes
- Patients with predicted risk score of 10 or less of pancreatic fistula
- Written informed consent
- Expected survival time > 6 months
Who cannot join
- Patients with predicted high risk of fistula with a risk score above 10
- Patients with intraabdominal abscess or infection
- ASA score > 3
- Pregnancy
- Expected lack of compliance
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites, 2 recruiting
- Recruiting
Linkoping University Hospital
Linköping, 582 72
Bergthor Björnsson, +46703766890, bergthor.bjornsson@liu.se
- Recruiting
Skanes University Hospital
Lund
Bobby Tingstedt
About this study
Official title: Post-operative Drainage After Pancreaticoduodenectomy: A Randomized Controlled Trial of Patients With Intermediate and Low Risk for Pancreatic Fistula
The study compares regular use of surgical drains and no use of surgical drains in patients subjected to pancreaticoduodenectomy with expected low to intermediate risk for post operative pancreatic fistula.
- Conditions
- Pancreatic Cancer
- Being tested
- Drain, No drain
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DrainProcedure or surgery
Surgical drains are placed as a standard of care (control arm) or not (experimental arm)
No drainProcedure or surgery
Surgical drains are placed as a standard of care (control arm) or not (experimental arm)
| Study group | Role | What they receive |
|---|---|---|
| Drain | Active comparator | Surgical drains used as routine Receives: Procedure: Drain |
| No drain | Experimental | No surgical drain used Receives: Procedure: No drain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall morbidity rate
Post operative morbidity
Measured: 90 days post operatively
Secondary outcomes (11)
Mortality rate (in-hospital, 30 and 90 days)
Measured: 90 days post operatively
Severe morbidity rate as classified by Clavien-Dindo >3
Measured: 90 days post operatively
Fistula rate according to ISGPF
Measured: 90 days post operatively
Intraabdominal abscess rate
Measured: 90 days post operatively
Wound infection rate
Measured: 90 days post operatively
Delayed gastric emptying according to ISGPF
Measured: 90 days post operatively
Postpancreatectomy bleeding according to ISGPF
Measured: 90 days post operatively
Need of interventional radiology
Measured: 90 days post operatively
Need for reoperation
Measured: 90 days post operatively
Hospital stay
Measured: 90 days post operatively
Readmission rate
Measured: 90 days post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start1 May 2016
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
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 Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- 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
- Model description
- Randomized controlled study
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- Lund University
- Responsible party
- Principal investigator, Bergthor Björnsson, Linkoeping University
- Investigators
- Bergthor Björnsson, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05270564
- Sponsor's protocol ID
- Drain_1
- Acronym
- Drain 1
- Status last verified
- Feb 2022
- First submitted
- 16 Feb 2022
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wallon S, Williamsson C, Karlsson V, Wennerblom J, Bratlie SO, Sandstrom P, Tingstedt B, Bjornsson B. Postoperative drainage after pancreatoduodenectomy: a randomized controlled trial among patients with intermediate and low risks for pancreatic fistula-DRAIN1. Trials. 2026 May 5;27(1):357. doi: 10.1186/s13063-026-09762-9.
PubMed 42083018
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Drainage After Pancreaticoduodenectomy: A Randomized Controlled Trial of Patients With Intermediate and Low Risk for Pancreatic Fistula
- ClinicalTrials.gov ID
- NCT05270564
- Acronym / sponsor ID
- Drain 1 / Drain_1
- Conditions
- Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- Lund University
- Study start
- 1 May 2016 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 8 Mar 2022 (actual)
- 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.
The study compares regular use of surgical drains and no use of surgical drains in patients subjected to pancreaticoduodenectomy with expected low to intermediate risk for post operative pancreatic fistula.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Drain | Active comparator | Procedure: DrainSurgical drains used as routine |
| No drain | Experimental | Procedure: No drainNo surgical drain used |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing pancreaticoduodenectomy of both sexes
- Patients with predicted risk score of 10 or less of pancreatic fistula
- Written informed consent
- Expected survival time > 6 months
Key exclusion criteria (5 listed)
- Patients with predicted high risk of fistula with a risk score above 10
- Patients with intraabdominal abscess or infection
- ASA score > 3
- Pregnancy
- Expected lack of compliance
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 |
|---|---|---|
| DrainSurgical drains are placed as a standard of care (control arm) or not (experimental arm) | Procedure or surgery | Drain |
| No drainSurgical drains are placed as a standard of care (control arm) or not (experimental arm) | Procedure or surgery | No drain |
Primary outcome
Overall morbidity rate
Time frame: 90 days post operatively
Post operative morbidity
11 secondary outcomes
Mortality rate (in-hospital, 30 and 90 days)
Time frame: 90 days post operatively
Severe morbidity rate as classified by Clavien-Dindo >3
Time frame: 90 days post operatively
Fistula rate according to ISGPF
Time frame: 90 days post operatively
Intraabdominal abscess rate
Time frame: 90 days post operatively
Wound infection rate
Time frame: 90 days post operatively
Delayed gastric emptying according to ISGPF
Time frame: 90 days post operatively
Postpancreatectomy bleeding according to ISGPF
Time frame: 90 days post operatively
Need of interventional radiology
Time frame: 90 days post operatively
Need for reoperation
Time frame: 90 days post operatively
Hospital stay
Time frame: 90 days post operatively
Readmission rate
Time frame: 90 days post operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Derived from this study: PubMed 42083018Wallon S, Williamsson C, Karlsson V, Wennerblom J, Bratlie SO, Sandstrom P, Tingstedt B, Bjornsson B. Postoperative drainage after pancreatoduodenectomy: a randomized controlled trial among patients with intermediate and low risks for pancreatic fistula-DRAIN1. Trials. 2026 May 5;27(1):357. doi: 10.1186/s13063-026-09762-9.
- Individual participant dataSharing planned: No
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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.
Bergthor Björnsson principal investigator
Linkoeping University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drain and No drain in people with Pancreatic Cancer, run by Linkoeping University at 2 sites in Sweden.
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 4 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: status not confirmed, as of the sponsor's last update on 8 Mar 2022. 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bergthor Björnsson (+46703766890, bergthor.bjornsson@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall morbidity rate (time frame: 90 days post operatively). 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 NCT05270564, 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 8 Mar 2022.