Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy

This study is currently recruiting participants.
Verified September 2012 by Zhejiang University
Sponsor:
Information provided by (Responsible Party):
TingBo Liang, Zhejiang University
ClinicalTrials.gov Identifier:
NCT01695447
First received: September 20, 2012
Last updated: September 27, 2012
Last verified: September 2012
  Purpose

The purpose of this study is to determine whether duct-to-mucosa is better than invagination in pancreaticojejunostomy after pancreaticoduodenectomy. This single-centre, open, randomized controlled trail is conducted following ISGPF criteria for pancreatic fistula (PF). The duration of the study is supposed to start from Jan 5th 2012 and last to Dec 2014, until 100 or more cases are accessible. Patients diagnosed with pancreatic cancer, peri-ampullar carcinoma or other benign or malignant diseases which need to operate pancreaticoduodenectomy will be included. Main outcomes are pancreatic fistula rate, mortality, morbidity, reoperation and hospital stay. The investigators assumption that duct-to-mucosa is better than invagination.


Condition Intervention
Pancreatic Neoplasms
Biliary Tract Neoplasms
Procedure: duct-to-mucosa
Procedure: invagination
Device: Internal stent

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised Controlled Trail of Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy After Pancreaticoduodenectomy

Resource links provided by NLM:


Further study details as provided by Zhejiang University:

Primary Outcome Measures:
  • pancreatic fistula [ Time Frame: From date of operation until the date of dischage or date of death from any cause, whichever came first,, assessed up to 200 days ] [ Designated as safety issue: Yes ]
    The determine of pancreatic fistula follows the International Study Group on Pancreatic Fistulas (ISGPF) criteria.


Secondary Outcome Measures:
  • Mortality [ Time Frame: From date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 200 days ] [ Designated as safety issue: Yes ]
    30-day or in-hospital mortality: death from any cause within 30 days after operation or any in-hospital death are considered concerned with the type of pancreaticojejunostomy

  • Morbidity [ Time Frame: From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days ] [ Designated as safety issue: Yes ]
    any complications after operation will be recorded.

  • Reoperation [ Time Frame: From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days ] [ Designated as safety issue: Yes ]
    Reasons and times of reoperation are recorded. The attending doctor will decided Whether reoperation is needed, according to indications and his experience.

  • Hospital stay [ Time Frame: From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days ] [ Designated as safety issue: Yes ]
    Post-operation hospital stay is assessed.


Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: duct-to-mucosa
duct-to-mucosa technique is used for pancreaticojejunostomy after pancreaticoduodenectomy
Procedure: duct-to-mucosa Device: Internal stent
Internal stent may be used during pancreaticojejunostomy according to the situation of pancreatic duct and experience of the surgeon.
Active Comparator: invagination
invagination technique is used for pancreaticojejunostomy after pancreaticoduodenectomy
Procedure: invagination Device: Internal stent
Internal stent may be used during pancreaticojejunostomy according to the situation of pancreatic duct and experience of the surgeon.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed with pancreatic cancer or other diseases which need pancreaticoduodenectomy and pancreaticojejunostomy
  • 18 to 80 y/o
  • Operation-tolerated
  • Informed consent

Exclusion Criteria:

  • History of gastrointestinal operation
  • Pancreaticoduodenectomy is given up during operation
  • Pancreatic duct is difficult to locate
  • Patients require to exit from the study anytime
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01695447

Contacts
Contact: Xue-Li Bai, Ph.D. +86 571 87783510 shirleybai57@hotmail.com

Locations
China, Zhejiang
the Second Affiliated Hospital, School of Medicine, Zhejiang Universtiy Recruiting
Hangzhou, Zhejiang, China, 310009
Contact: Ting-Bo Liang, Ph.D., M.D.    +86 571 87783510    liangtingbo@zju.edu.cn   
Sponsors and Collaborators
TingBo Liang
  More Information

No publications provided

Responsible Party: TingBo Liang, The Second Affiliated Hospital, School of Medicine, Zhejiang Universtiy, Zhejiang University
ClinicalTrials.gov Identifier: NCT01695447     History of Changes
Other Study ID Numbers: ZEH-LL-CX-004-02
Study First Received: September 20, 2012
Last Updated: September 27, 2012
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Biliary Tract Neoplasms
Neoplasms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 16, 2014