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Pancreatic Duct Stenting to Prevent Postoperative Pancreatic Fistula (POPF) After Distal Pancreatectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02573389
Recruitment Status : Suspended (lack of accrual due to competing study)
First Posted : October 9, 2015
Last Update Posted : August 2, 2018
Information provided by (Responsible Party):
Kaiser Permanente

Brief Summary:
To determine whether pre-operative pancreatic stenting for distal pancreatectomy will impact the incidence of a post-operative pancreatic fistula, as defined by postoperative. If pre-operative pancreatic stenting appears to reduce the formation of Postoperative Pancreatic Fistula (POPF) in this pilot study, this will form the basis of a larger randomized trial in the future. The hypothesis is that pre-operative pancreatic duct stenting can significantly decrease the rate of development of a post-operative pancreatic fistula after distal pancreatectomy.

Condition or disease Intervention/treatment Phase
Pancreatitis Device: Boston Scientific or Cook pancreatic duct stents Phase 3

Detailed Description:
Prophylactic pancreatic duct stenting is to be offered to all patients deemed a candidate for a distal pancreatectomy. This is a nonrandomized cohort study with a retrospective and prospective control group (Jan 2008 - Dec 2017 or sample size obtained) and a prospective endoscopic intervention group (September 2015 - Dec 2017 or until sample size obtained). We will then compare the rate of development of a postoperative pancreatic fistula between those patients who have preoperative stenting and those who do not. POPF will be defined as the amylase level of drain contents equaling three times or more the serum amylase on postoperative day 3, as defined by the International Study Group for Pancreatic Fistula (ISGPF) or an ICD-9 diagnosis of 577.8. The patient will have a pre-operative visit for stent placement and a post-operative visit for stent removal if still in place 4-6 weeks after distal pancreatectomy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Pilot Study on the Effect of Transampullary Pancreatic Duct Stenting on Postoperative Pancreatic Fistula Rate After Distal Pancreatectomy
Actual Study Start Date : December 4, 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Retrospective and prospective "non-stented"
Non-stented patients undergoing distal pancreatectomy retrospectively (2008-2015) and prospectively from 2015 to 2017.
Experimental: Prospective "stented"
Patients who undergo prophylactic pancreatic duct stenting prior to a distal pancreatectomy starting approximately September 2015.
Device: Boston Scientific or Cook pancreatic duct stents
Boston Scientific or Cook straight or pigtail pancreatic stents. Stent size depends on duct size (capacity). Pancreatic plastic stents are made primarily of polyethylene materials. Pancreatic stent sizes range from 2 to 25 cm in length and 3F to 11.5F in.

Primary Outcome Measures :
  1. Post-operative pancreatic fistula [ Time Frame: At 6 months when enrollment begins ]

    Rate of post-operative pancreatic fistula will be evaluated at 6 months when enrollment begins. Early stop is determined under either of below conditions:

    • Effect size is smaller than needed to reach statistical difference even if number of enrollment is completed in one year.
    • Adverse events occurring from the pancreatic duct stenting itself, which include pseudocyst, delaying surgery, pancreatitis requiring prolonged hospital admission, or death.
    • There is statistical significant difference between control and intervention groups.

Secondary Outcome Measures :
  1. Pre-operative: Pancreatitis from pancreatic duct stent [ Time Frame: 1 - 2 weeks prior to distal pancreatectomy ]
  2. Postoperative: Abscess, hemorrhage, reoperation, pulmonary embolism, mortality [ Time Frame: 3 days post surgery ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Adult patients age 18 years of age and older
  2. Patients undergoing distal pancreatectomy for primary pancreatic disorder or isolated metastases to the pancreas.

Exclusion Criteria:

  1. Pediatric patients younger than age 18
  2. Pregnant patients
  3. Patients undergoing distal pancreatectomies performed en bloc for non- pancreatic pathologies (gastric cancer, renal cell cancer, etc).

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 identifier (NCT number): NCT02573389

Sponsors and Collaborators
Kaiser Permanente
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Principal Investigator: Louis A DiFronzo, MD Kaiser Permanente
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Responsible Party: Kaiser Permanente Identifier: NCT02573389    
Other Study ID Numbers: KPSC IRB 10705
KPSC IRB10705 ( Other Identifier: Kaiser Permanente Southern California IRB )
First Posted: October 9, 2015    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018
Keywords provided by Kaiser Permanente:
pancreatic fistula, pancreatectomy, endoscopic stenting, pancreatic stenting, distal pancreatectomy
Additional relevant MeSH terms:
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Pancreatic Fistula
Pathological Conditions, Anatomical
Pancreatic Diseases
Digestive System Diseases
Digestive System Fistula