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

NCT ID: NCT02220010

Last Updated: 2014-08-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2017-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Pancreatic stent

Intervention Type: DEVICE

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

Drain only

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pancreatic stent

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

Intervention Type: DEVICE

Other Intervention Names

Pancreatic duct stent (made of plastic material)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sahlgrenska University Hospital

OTHER

Sponsor Role: collaborator

Lund University Hospital

OTHER

Sponsor Role: collaborator

University Hospital, Linkoeping

OTHER

Sponsor Role: collaborator

Norrlands University Hospital

OTHER

Sponsor Role: collaborator

Karolinska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

John Blomberg

M.D., PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dep of Surgical Gastroenterology, Karolinska University Hospital

Stockholm, , Sweden

Site Status: RECRUITING

Countries

Sweden

Facility Contacts

John Blomberg, MD, PhD

Role: primary

john.blomberg@karolinska.se

+46(0)703983060

Christoph Ansorge, MD, PhD

Role: backup

christoph.ansorge@karolinska.se

Other Identifiers

POPF and stenting-002

Identifier Type: -

Identifier Source: org_study_id