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

Karolinska University Hospital

Status: Unknown

Conditions: Healing Time of Post Operative Pancreatic Fistulas

Treatments: Device: Pancreatic stent

Study type: Interventional

Funder types: Other

Identifiers

NCT02220010

POPF and stenting-002

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Pancreatic stent

Experimental group

Description:

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.

Treatment:

Device: Pancreatic stent

Drain only

No Intervention group

Description:

If POPF grade B or C is detected on post operative day 3 or more, only the per-operatively placed drain is used as treatment