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Route of Nutritional Support for Pancreatic Fistula

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01755260
First received: December 18, 2012
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cost of therapy [ Time Frame: 30 days ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01755260

Contacts
Contact: Jin-Ming Wu, MD kptkptkpt@yahoo.com.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
Contact: Yu-Wen Tien       ywtien5106@ntu.edu.tw   
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
Contact: Yu-Wen Tien       ywtien5106@ntu.edu.tw   
Principal Investigator: Yu-Wen Tien         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Yu-Wen Tien National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01755260     History of Changes
Other Study ID Numbers: 201202048RIB
Study First Received: December 18, 2012
Last Updated: April 14, 2014
Health Authority: Taiwan: Department of Health

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

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

ClinicalTrials.gov processed this record on November 27, 2014