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

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ClinicalTrials.gov Identifier: NCT02220010
Recruitment Status : Unknown
Verified August 2014 by John Blomberg, Karolinska University Hospital.
Recruitment status was:  Recruiting
First Posted : August 19, 2014
Last Update Posted : August 19, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Healing Time of Post Operative Pancreatic Fistulas Device: Pancreatic stent

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does a Pancreatic Stent Reduce the Healing Time of Post Operative Pancreatic Fistula (POPF) After Distal Pancreatic Resection - an Open Randomized Clinical Multicenter Trial
Study Start Date : June 2014
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas
U.S. FDA Resources

Arms and Interventions

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 Name: 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


Outcome Measures

Primary Outcome Measures :
  1. POPF healing time (days) [ Time Frame: 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 :
  1. POPF grade (A,B,C) [ Time Frame: 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.


Other Outcome Measures:
  1. Blood chemistry [ Time Frame: 12 days (median hospital stay) ]
    C-reactive protein, white blood cell count and pancreas amylase in plasma and drains

  2. Morbidity [ Time Frame: 12 days (median in hospital stay) ]
    Classification according to Clavien-Dindo

  3. Mortality [ Time Frame: < 90 days after the operation ]
  4. Hospital stay [ Time Frame: 12 days (median hospital stay) ]
    Number of days in hospital


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220010


Locations
Sweden
Dep of Surgical Gastroenterology, Karolinska University Hospital Recruiting
Stockholm, Sweden, SE-141 86
Contact: John Blomberg, MD, PhD    +46(0)703983060    john.blomberg@karolinska.se   
Contact: Christoph Ansorge, MD, PhD       christoph.ansorge@karolinska.se   
Principal Investigator: John Blomberg, MD, PhD         
Sub-Investigator: Christoph Ansorge, MD, PhD         
Sponsors and Collaborators
Karolinska University Hospital
Sahlgren´s University Hospital
Lund University Hospital
University Hospital, Linkoeping
Norrlands University Hospital
More Information

Responsible Party: John Blomberg, M.D., PhD, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT02220010     History of Changes
Other Study ID Numbers: POPF and stenting-002
First Posted: August 19, 2014    Key Record Dates
Last Update Posted: August 19, 2014
Last Verified: August 2014

Keywords provided by John Blomberg, Karolinska University Hospital:
Post operative pancreatic fistulas
Pancreatic stenting

Additional relevant MeSH terms:
Fistula
Pancreatic Fistula
Pathological Conditions, Anatomical
Digestive System Fistula
Digestive System Diseases
Pancreatic Diseases