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Comparison of Feasibility Between Internal and External Pancreatic Drainage in Pancreaticoduodenectomy

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ClinicalTrials.gov Identifier: NCT01023594
Recruitment Status : Unknown
Verified September 2015 by Sun-Whe Kim, Seoul National University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : December 2, 2009
Last Update Posted : September 15, 2015
Sponsor:
Information provided by (Responsible Party):
Sun-Whe Kim, Seoul National University Hospital

Brief Summary:
Pancreatic fistula is one of the most serious complication after pancreatoduodenectomy. To reduce pancreatic fistula, many authors recommend pancreatic stent in pancreatojejunostomy. There are two distinct methods of pancreatic stent insertion: internal stent and external stent. There was few studies comparing these methods in preventing pancreatic fistula. Furthermore, its long-term effect was not known enough. The purpose of this study is to determine which is the best method in preventing pancreatic fistula and to investigate its long term clinical outcomes.

Condition or disease Intervention/treatment Phase
Pancreatic Fistula Procedure: Pancreatic stent Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 328 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparison of Feasibility Between Internal and External Pancreatic Drainage in Pancreaticoduodenectomy: Prospective Randomized Study
Study Start Date : January 2010
Actual Primary Completion Date : January 2014
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
Active Comparator: External stent
Feeding tube insert at pancreatojejunostomy site as a stent. And stent tube is brought out through jejunal loop below the hepaticojejunostomy site and abdominal wall.
Procedure: Pancreatic stent
Feeding tube insert at pancreatojejunostomy site as a stent. And then 1) tube is brought out through jejunal loop below the hepaticojejunostomy site and abdominal wall(external stent)or 2) tube is cut short (5cm length) and left in situ with fixating suture. In external stent group, tube will be removed about 1 months after operation.

Active Comparator: Internal stent
short(5cm)internal stent insertion at pancreatojejunostomy site
Procedure: Pancreatic stent
Feeding tube insert at pancreatojejunostomy site as a stent. And then 1) tube is brought out through jejunal loop below the hepaticojejunostomy site and abdominal wall(external stent)or 2) tube is cut short (5cm length) and left in situ with fixating suture. In external stent group, tube will be removed about 1 months after operation.




Primary Outcome Measures :
  1. evidence of pancreatic fistula confirmed by serum and drain amylase [ Time Frame: within the first 7 days after surgery ]

Secondary Outcome Measures :
  1. pancreatic endocrine and exocrine function by blood test, stool exam (steatorrhea) and computed tomography (CT) volumetry [ Time Frame: within the first 1 year after surgery ]


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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patient who have malignant or benign disease which needs pancreatoduodenectomy
  • patient age: ≥20 and ≤85

Exclusion Criteria:

  • patient who had chemotherapy or radiotherapy previous to operation.
  • patient who had severe comorbid disease(cardiac, pulmonary, cerebrovascular)
  • patient who had past medical history of chronic pancreatitis.
  • pancreatic stent size <1mm or >5mm

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): NCT01023594


Locations
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Korea, Republic of
Center for Liver Cancer, National Cancer Center
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Department of Surgery, Seoul National University Bundang Hospital
Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
Department of Surgery, Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Department of Surgery, Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Department of Surgery, Korea University Guro Hospital
Seoul, Korea, Republic of, 152-703
Department of Surgery, Seoul National University Boramae Hospital
Seoul, Korea, Republic of, 156-707
Department of Surgery, Chung-ang University College of Medicine
Seoul, Korea, Republic of
Department of Surgery, Gangnam Severance Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Study Chair: Sun-Whe Kim, M.D. Seoul National University Hospital

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sun-Whe Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01023594     History of Changes
Other Study ID Numbers: H-0908-040-290
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: September 15, 2015
Last Verified: September 2015

Keywords provided by Sun-Whe Kim, Seoul National University Hospital:
Pancreatic fistula
Pancreatic leakage
Pancreatoduodenectomy
Pancreatic stent

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