We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Route of Nutritional Support for Pancreatic Fistula

This study is currently recruiting participants.
Verified October 2016 by National Taiwan University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01755260
First Posted: December 24, 2012
Last Update Posted: October 5, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Taiwan University Hospital
  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
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

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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01755260     History of Changes
Other Study ID Numbers: 201202048RIB
First Submitted: December 18, 2012
First Posted: December 24, 2012
Last Update Posted: October 5, 2016
Last Verified: October 2016

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

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


To Top