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Route of Nutritional Support for Pancreatic Fistula

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: NCT01755260
Recruitment Status : Unknown
Verified October 2016 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : December 24, 2012
Last Update Posted : October 5, 2016
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
The aim of this study is to compare the closure rate of pancreatic fistula (PF) after pancreaticoduodenectomy (PD) under various types of nutrition.

Condition or disease Intervention/treatment Phase
Closure of POPF After Pancreaticoduodenectomy Other: Jejunostomy tube feeding Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nutrition Through Oral Intake Versus Feeding Jejunostomy in the Conservative Treatment of Pancreatic Fistula After Pancreaticoduodenectomy: a Prospective Multicenter Randomized Clinical Trial
Study Start Date : September 2013
Estimated Primary Completion Date : December 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: oral intake
The patients at this arm were allowed to take food through mouth
Other: Jejunostomy tube feeding
The patients at this arm receive the nutritional support through the feeding jejunostomy tube; they can only eat or sip water through mouth

Primary Outcome Measures :
  1. Closure of pancreatic fistula within 30 days [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Cost of therapy [ Time Frame: 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • aged more than 20 years old and develop pancreatic fistula after pancreatectomy

Exclusion Criteria:

  • major co-morbidities
  • severe pancreatic fistula needing intervention

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): NCT01755260

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Contact: Jin-Ming Wu, MD

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National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
Contact: Yu-Wen Tien   
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
Contact: Yu-Wen Tien   
Principal Investigator: Yu-Wen Tien         
Sponsors and Collaborators
National Taiwan University Hospital
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Principal Investigator: Yu-Wen Tien National Taiwan University Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: National Taiwan University Hospital Identifier: NCT01755260    
Other Study ID Numbers: 201202048RIB
First Posted: December 24, 2012    Key Record Dates
Last Update Posted: October 5, 2016
Last Verified: October 2016
Keywords provided by National Taiwan University Hospital:
enteral nutrition
parenteral nutrition
Additional relevant MeSH terms:
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Pancreatic Fistula
Pathological Conditions, Anatomical
Digestive System Fistula
Digestive System Diseases
Pancreatic Diseases