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Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy

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ClinicalTrials.gov Identifier: NCT01695447
Recruitment Status : Recruiting
First Posted : September 28, 2012
Last Update Posted : January 26, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Pancreatic Neoplasms Biliary Tract Neoplasms Procedure: duct-to-mucosa Procedure: invagination Device: Internal stent

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised Controlled Trail of Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy After Pancreaticoduodenectomy
Study Start Date : January 2012
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017
Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria

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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

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): 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

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
First Posted: September 28, 2012    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017

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