Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by Zhejiang University.
Recruitment status was:  Recruiting
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
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

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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01695447

Locations
China, Zhejiang
the Second Affiliated Hospital, School of Medicine, Zhejiang Universtiy
Hangzhou, Zhejiang, China, 310009
Sponsors and Collaborators
TingBo Liang
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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

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

ClinicalTrials.gov processed this record on January 19, 2017