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

NCT02220010 | Unknown

• 1 other identifier: POPF and stenting-002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Healing Time of Post Operative Pancreatic Fistulas

Keywords

Post operative pancreatic fistulas; Pancreatic stenting

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• POPF grade (A,B,C)

  12 days (median hospital stay)

Other Outcomes (4)

• Blood chemistry

  12 days (median hospital stay)

• Morbidity

  12 days (median in hospital stay)

• Mortality

  < 90 days after the operation

Study Arms (2)

Pancreatic stent

EXPERIMENTAL

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.

Device: Pancreatic stent

Drain only

NO INTERVENTION

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

Interventions

Pancreatic stent DEVICE

The plastic stent is introduced in the pancreatic duct by a duodenoscope

Also known as: Pancreatic duct stent (made of plastic material)

Pancreatic stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Left sided or distal pancreatic resection
• Grade B or C fistula on postoperative day 3 or later

You may not qualify if:

• Do not want to participate in study
• Can not read patient information in swedish
• The papilla can not be endoscopically reached

Sponsors & Collaborators

• Karolinska University Hospital: lead
• Sahlgrenska University Hospital: collaborator
• Lund University Hospital: collaborator
• University Hospital, Linkoeping: collaborator
• Norrlands University Hospital: collaborator

Study Sites (1)

Dep of Surgical Gastroenterology, Karolinska University Hospital

Stockholm, SE-141 86, Sweden

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., PhD

Study Record Dates

• First Submitted: August 18, 2014
• First Posted: August 19, 2014
• Study Start: June 1, 2014
• Primary Completion: August 1, 2017
• Study Completion: October 1, 2017
• Last Updated: August 19, 2014

Record last verified: 2014-08

Locations

SE (1)