Healing Time of Post Operative Pancreatic Fistulas Clinical Trial
Official title:
Does a Pancreatic Stent Reduce the Healing Time of Post Operative Pancreatic Fistula (POPF) After Distal Pancreatic Resection - an Open Randomized Clinical Multicenter Trial
| Verified date | August 2014 |
| Source | Karolinska University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Sweden: Medical Products Agency |
| Study type | Interventional |
Dividing pancreas when performing left-sided resections opens the risk for leakage from the
divided end of the pancreas. Pancreatic juices could have a severe effect on surrounding
abdominal tissues with abscess formation producing systemic inflammation and potential
lethal bleeding. Proper drainage of pancreatic juices is the primary treatment. Effective
drainage reduces healing time. A pancreatic stent could theoretically improve the drainage
of pancreatic juice into the duodenum and by this shorten the healing time still further.
Pre operative prophylactic stenting of the pancreas before division of the parenchyma has
not shown a positive effect on fistula formation.
In an open randomized multicenter clinical trial we want to test the hypothesis that a
reduced fistula healing time, in left sided pancreatic resections, could be reduced by
introducing a pancreatic stent when on post operative day 3 or later a B och C fistula
(according to the International Study Group on Pancreatic Fistula, ISGPF) is diagnosed by
randomizing between pancreatic stent with drains versus only drains.
| Status | Recruiting |
| Enrollment | 60 |
| Est. completion date | October 2017 |
| Est. primary completion date | August 2017 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Signed informed consent - Left sided or distal pancreatic resection - Grade B or C fistula on postoperative day 3 or later Exclusion Criteria: - Do not want to participate in study - Can not read patient information in swedish - The papilla can not be endoscopically reached |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Dep of Surgical Gastroenterology, Karolinska University Hospital | Stockholm |
| Lead Sponsor | Collaborator |
|---|---|
| Karolinska University Hospital | Lund University Hospital, Norrlands University Hospital, Sahlgren´s University Hospital, University Hospital, Linkoeping |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Blood chemistry | C-reactive protein, white blood cell count and pancreas amylase in plasma and drains | 12 days (median hospital stay) | No |
| Other | Morbidity | Classification according to Clavien-Dindo | 12 days (median in hospital stay) | No |
| Other | Mortality | < 90 days after the operation | No | |
| Other | Hospital stay | Number of days in hospital | 12 days (median hospital stay) | No |
| Primary | POPF healing time (days) | Post operative pancreatic fistula(POPF) and grade (A,B,C) is diagnosed according to ISGPF on post operative day 3 or later if the pancrease-amylase concentration is more than three times the upper limit of the normal plasma concentration of pancreas-amylase. When the drain fluid concentration is below this value the fistula is defined as healed. | 12 days (median hospital stay) | No |
| Secondary | POPF grade (A,B,C) | International Study Group on Pancreatic Fistula (ISGPF) (Bassi et al 2005)defines fistula grade A-C. Grade A is leakage of pancreatic juice with a concentration of more than 3 times the upper normal level in plasma but no other clinical implication for the patient. If an inflammatory response is seen, but not sepsis, it is graded as B fistula and if sepsis occurs and/or single- or multi-organ dysfunction is seen it is graded as C. | 12 days (median hospital stay) | No |