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

Does a Pancreatic Stent Reduce the Healing Time of Post Operative Pancreatic Fistula (POPF) After Distal Pancreatic Resection - an Open Randomized Clinical Multicenter Trial

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.

Study Overview

• Status: Unknown
• Conditions: Healing Time of Post Operative Pancreatic Fistulas
• Intervention / Treatment: Device: Pancreatic stent

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, SE-141 86
    • Recruiting
    • Dep of Surgical Gastroenterology, Karolinska University Hospital
    • Contact: John Blomberg, MD, PhD; Phone Number: +46(0)703983060; Email: john.blomberg@karolinska.se
    • Contact: Christoph Ansorge, MD, PhD; Email: christoph.ansorge@karolinska.se
    • Principal Investigator: John Blomberg, MD, PhD
    • Sub-Investigator: Christoph Ansorge, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Pancreatic stent; The plastic stent is introduced in the pancreatic duct by a duodenoscope; Other Names: Pancreatic duct stent (made of plastic material)
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
POPF grade (A,B,C)	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.	12 days (median hospital stay)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood chemistry	C-reactive protein, white blood cell count and pancreas amylase in plasma and drains	12 days (median hospital stay)
Morbidity	Classification according to Clavien-Dindo	12 days (median in hospital stay)
Mortality		< 90 days after the operation
Hospital stay	Number of days in hospital	12 days (median hospital stay)

Collaborators and Investigators

• Sponsor: Karolinska University Hospital
• Collaborators: University Hospital, Linkoeping; Lund University Hospital; Sahlgren´s University Hospital; Norrlands University Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): October 1, 2017

Study Registration Dates

• First Submitted: August 18, 2014
• First Submitted That Met QC Criteria: August 18, 2014
• First Posted (Estimate): August 19, 2014

Study Record Updates

• Last Update Posted (Estimate): August 19, 2014
• Last Update Submitted That Met QC Criteria: August 18, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Post operative pancreatic fistulas; Pancreatic stenting
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Pancreatic Diseases; Digestive System Fistula; Fistula; Pancreatic Fistula
• Other Study ID Numbers: POPF and stenting-002