Does Post Operative Pancreatic Fistula, After Left Sided Resections, Heal Faster After the Introduction of a Pancreatic Stent?

Not Applicable

• Conditions: Healing Time of Post Operative Pancreatic Fistulas
• Interventions: Device: Pancreatic stent

• Registration Number: NCT02220010
• Lead Sponsor: Karolinska University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Status Verified: 2014-08
• Study First Submitted: 2014-08-18
• Study First Submitted QC: 2014-08-18
• Last Update Submitted: 2014-08-18
• Study First Posted: 2014-08-19
• Last Update Posted: 2014-08-19
• Primary Completion: 2017-08
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pancreatic stent	Pancreatic stent	If POPF grade B or C is detected on post operative day 3 or more, a pancreatic stent is endoscopically positioned in the pancreatic duct.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Dep of Surgical Gastroenterology, Karolinska University Hospital; 🇸🇪 Stockholm, Sweden