Pancreatic FistulaNCT02343302
Prospective Trial Evaluating the Effect of Closed Suction Drainage Versus Straight Drainage After Distal Pancreatectomy
A study testing Jackson-Pratt Drain and Non-suctioning drainage in people with Pancreatic Fistula, run by Johns Hopkins University at 1 site in United States.
Trial summary
A very common complication following distal pancreatectomy is leakage from the pancreas, or what is called a pancreatic fistula. We hypothesize that operative drains which create suction may contribute to the development of leakage from the pancreas. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pancreatic Fistula
- What is being tested?
- Jackson-Pratt Drain and Non-suctioning drainage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to 20 Feb 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing distal pancreatectomy at Johns Hopkins Hospital
Who cannot join
- Children <18 years old, pregnant women, adults lacking capacity to consent, non-english speakers, and prisoners.
Trial locations and contacts
1 site in 1 country.
About this study
A very common complication following distal pancreatectomy is leakage from the pancreas, or what is called a pancreatic fistula. We hypothesize that operative drains which create suction may contribute to the development of leakage from the pancreas. This study evaluates the effect of using non-suctioning drains to prevent the development of this complication.
Read the detailed description
The most common complication following distal pancreatectomy is the developement of leakage from the remaining pancreas gland, which results in significant morbidity. Most surgeons leave dains at the time of surgery to prevent complications from pancreatic leakage. However, we hypothesize that drains which create continous negative pressure may contribute to the development of a pancreatic fistula. This study randomizes patients to suctioning versus non-suctioning drains. The primary endpoint is the development of pancreatic fistuale, as defined by the International Study Group of Pancreatic Surgery.
- Conditions
- Pancreatic Fistula
- Being tested
- Jackson-Pratt Drain, Non-suctioning drainage
- Keywords
- Pancreatic Fistula
- Medical subject headings
- Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jackson-Pratt DrainDevice
A closed suctioning drain will be placed at the time of surgery. Patients in both arm A and arm B will receive this intervention. The patients that receive this treatment will be the ones whose envelope, selected on the basis of the texture of the gland, contains a card labelled "suction drain"
Non-suctioning drainageDevice
A closed non-suctioning drain will be placed at the time of surgery. Patients in both arm A and arm B will receive this intervention. The patients that receive this treatment will be the ones whose envelope, selected on the basis of the texture of the gland, contains a card labelled "gravity drain"
| Study group | Role | What they receive |
|---|---|---|
| Soft Pancreatic Gland | Other | This arm will be patients with glands felt to have a soft texture during surgery. This arm will receive either a suction drain or a gravity drain based on the note inside the sealed envelope. Receives: Device: Jackson-Pratt Drain; Device: Non-suctioning drainage |
| Hard Pancreatic Gland | Other | This arm will include patients felt to have a hard gland tecture at the time of surgery. This arm will receive either a suction drain or a gravity drain based on the note inside the sealed envelope. Receives: Device: Jackson-Pratt Drain; Device: Non-suctioning drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Pancreatic Fistula
The primary endpoint of the study is the developement of post-operative pancreatic fistula, as defined by the International Study Group of Pancreatic Surgery.
Measured: 90 days
Secondary outcomes (1)
Morbidity
All morbidity, including length of hospital stay, need for enteral/parenteral nutrition, need for radiologic/surgical intervention, septic complications, and peri-operative mortality.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2015 (estimated)
- Study startFeb 2013
- Primary completion15 Feb 2021
- Study completion20 Feb 2021
Why it stopped: Poor patient accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic FistulaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher L Wolfgang, MD PHD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02343302
- Sponsor's protocol ID
- NA_00080937
- Other IDs
- IRB00197557
- Status last verified
- Mar 2021
- First submitted
- 15 Jan 2015
- Last updated
- 21 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Trial Evaluating the Effect of Closed Suction Drainage Versus Straight Drainage After Distal Pancreatectomy
- ClinicalTrials.gov ID
- NCT02343302
- Acronym / sponsor ID
- NA_00080937
- Conditions
- Pancreatic Fistula
- Keywords
- Pancreatic Fistula
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor patient accrual
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Feb 2013 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 20 Feb 2021 (actual)
- First posted
- 21 Jan 2015 (estimated)
- Results
- Posted 21 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A very common complication following distal pancreatectomy is leakage from the pancreas, or what is called a pancreatic fistula. We hypothesize that operative drains which create suction may contribute to the development of leakage from the pancreas. This study evaluates the effect of using non-suctioning drains to prevent the development of this complication.
Detailed description
The most common complication following distal pancreatectomy is the developement of leakage from the remaining pancreas gland, which results in significant morbidity. Most surgeons leave dains at the time of surgery to prevent complications from pancreatic leakage. However, we hypothesize that drains which create continous negative pressure may contribute to the development of a pancreatic fistula. This study randomizes patients to suctioning versus non-suctioning drains. The primary endpoint is the development of pancreatic fistuale, as defined by the International Study Group of Pancreatic Surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soft Pancreatic Gland | Other | Device: Jackson-Pratt Drain, Device: Non-suctioning drainageThis arm will be patients with glands felt to have a soft texture during surgery. This arm will receive either a suction drain or a gravity drain based on the note inside the sealed envelope. |
| Hard Pancreatic Gland | Other | Device: Jackson-Pratt Drain, Device: Non-suctioning drainageThis arm will include patients felt to have a hard gland tecture at the time of surgery. This arm will receive either a suction drain or a gravity drain based on the note inside the sealed envelope. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing distal pancreatectomy at Johns Hopkins Hospital
Key exclusion criteria (1 listed)
- Children <18 years old, pregnant women, adults lacking capacity to consent, non-english speakers, and prisoners.
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 |
|---|---|---|
| Jackson-Pratt DrainA closed suctioning drain will be placed at the time of surgery. Patients in both arm A and arm B will receive this intervention. The patients that receive this treatment will be the ones whose envelope, selected on the basis of the texture of the gland, contains a card labelled "suction drain" | Device | Hard Pancreatic Gland, Soft Pancreatic Gland |
| Non-suctioning drainageA closed non-suctioning drain will be placed at the time of surgery. Patients in both arm A and arm B will receive this intervention. The patients that receive this treatment will be the ones whose envelope, selected on the basis of the texture of the gland, contains a card labelled "gravity drain" | Device | Hard Pancreatic Gland, Soft Pancreatic Gland |
Primary outcome
Post-operative Pancreatic Fistula
Time frame: 90 days
The primary endpoint of the study is the developement of post-operative pancreatic fistula, as defined by the International Study Group of Pancreatic Surgery.
1 secondary outcome
Morbidity
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Christopher L Wolfgang, MD PHD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jackson-Pratt Drain and Non-suctioning drainage in people with Pancreatic Fistula, run by Johns Hopkins University at 1 site in United States.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 21 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Post-operative Pancreatic Fistula (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2021.