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Route of Nutritional Support for Pancreatic Fistula

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by National Taiwan University Hospital
Information provided by (Responsible Party):
National Taiwan University Hospital Identifier:
First received: December 18, 2012
Last updated: October 4, 2016
Last verified: October 2016
The aim of this study is to compare the closure rate of pancreatic fistula (PF) after pancreaticoduodenectomy (PD) under various types of nutrition.

Condition Intervention
Closure of POPF After Pancreaticoduodenectomy
Other: Jejunostomy tube feeding

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (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

Resource links provided by NLM:

Further study details as provided by National Taiwan University Hospital:

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

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

Estimated Enrollment: 80
Study Start Date: September 2013
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description


Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01755260

Contact: Jin-Ming Wu, MD

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
Principal Investigator: Yu-Wen Tien National Taiwan University Hospital
  More Information

Responsible Party: National Taiwan University Hospital Identifier: NCT01755260     History of Changes
Other Study ID Numbers: 201202048RIB
Study First Received: December 18, 2012
Last Updated: October 4, 2016

Keywords provided by National Taiwan University Hospital:
enteral nutrition
parenteral nutrition

Additional relevant MeSH terms:
Pancreatic Fistula
Pathological Conditions, Anatomical
Digestive System Fistula
Digestive System Diseases
Pancreatic Diseases processed this record on May 25, 2017