Healing Time of Post Operative Pancreatic Fistulas
Conditions
Keywords
Post operative pancreatic fistulas, Pancreatic stenting
Brief summary
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.
Interventions
DEVICEPancreatic stent
The plastic stent is introduced in the pancreatic duct by a duodenoscope
Sponsors
Sahlgrenska University Hospital
Lund University Hospital
University Hospital, Linkoeping
Norrlands University Hospital
Karolinska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| POPF healing time (days) | 12 days (median hospital stay) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| POPF grade (A,B,C) | 12 days (median hospital stay) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Blood chemistry | 12 days (median hospital stay) | C-reactive protein, white blood cell count and pancreas amylase in plasma and drains |
| Morbidity | 12 days (median in hospital stay) | Classification according to Clavien-Dindo |
| Mortality | < 90 days after the operation | — |
| Hospital stay | 12 days (median hospital stay) | Number of days in hospital |
Countries
Sweden
Outcome results
None listed