An interventional study of Jackson-Pratt Drain and Non-suctioning drainage in Pancreatic Fistula, sponsored by Johns Hopkins University. Terminated at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-12-21.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
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.
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.
125 studies on the registry are indexed under Pancreatic Fistula; 27 are open to participants now.
This study's enrollment of 2 is below the median of 110 across 75 interventional studies indexed under Pancreatic Fistula.
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Exclusion Criteria:
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.
Device: Jackson-Pratt Drain · Device: Non-suctioning drainage
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.
Device: Jackson-Pratt Drain · Device: Non-suctioning drainage
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"
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"
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.
Time frame: 90 days
Morbidity
All morbidity, including length of hospital stay, need for enteral/parenteral nutrition, need for radiologic/surgical intervention, septic complications, and peri-operative mortality.
Time frame: 90 days
| Milestone | Soft Pancreatic Gland | Hard Pancreatic Gland |
|---|---|---|
| Started | 1 | 1 |
| Completed | 0 | 0 |
| Not completed | 1 | 1 |
| Withdrew: Physician decision | 1 | 1 |
The primary endpoint of the study is the developement of post-operative pancreatic fistula, as defined by the International Study Group of Pancreatic Surgery.
No measurements were reported for this outcome.
All morbidity, including length of hospital stay, need for enteral/parenteral nutrition, need for radiologic/surgical intervention, septic complications, and peri-operative mortality.
No measurements were reported for this outcome.
Collected over Not applicable. Work on this project was discontinued. No adverse event data was collected.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Soft Pancreatic Gland | — | — | — |
| Hard Pancreatic Gland | — | — | — |
Work on this project was discontinued. Baseline data was not collected for any participants.
| Age, Categorical | Soft Pancreatic Gland | Hard Pancreatic Gland | Total |
|---|---|---|---|
| <=18 years | — | — | — |
| Between 18 and 65 years | — | — | — |
| >=65 years | — | — | — |
| Age, Continuous | Soft Pancreatic Gland | Hard Pancreatic Gland | Total |
|---|
| Sex: Female, Male | Soft Pancreatic Gland | Hard Pancreatic Gland | Total |
|---|---|---|---|
| Female | — | — | — |
| Male | — | — | — |
| Race and Ethnicity Not Collected | Soft Pancreatic Gland | Hard Pancreatic Gland | Total |
|---|
| Region of Enrollment | Soft Pancreatic Gland | Hard Pancreatic Gland | Total |
|---|
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