Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy
Primary Purpose
Pancreatic Neoplasms, Biliary Tract Neoplasms
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
duct-to-mucosa
invagination
Internal stent
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Neoplasms
Eligibility 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
Sites / Locations
- the Second Affiliated Hospital, School of Medicine, Zhejiang UniverstiyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
duct-to-mucosa
invagination
Arm Description
duct-to-mucosa technique is used for pancreaticojejunostomy after pancreaticoduodenectomy
invagination technique is used for pancreaticojejunostomy after pancreaticoduodenectomy
Outcomes
Primary Outcome Measures
pancreatic fistula
The determine of pancreatic fistula follows the International Study Group on Pancreatic Fistulas (ISGPF) criteria.
Secondary Outcome Measures
Mortality
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
any complications after operation will be recorded.
Reoperation
Reasons and times of reoperation are recorded. The attending doctor will decided Whether reoperation is needed, according to indications and his experience.
Hospital stay
Post-operation hospital stay is assessed.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01695447
Brief Title
Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy
Official Title
Randomised Controlled Trail of Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy After Pancreaticoduodenectomy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
TingBo Liang
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neoplasms, Biliary Tract Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
duct-to-mucosa
Arm Type
Experimental
Arm Description
duct-to-mucosa technique is used for pancreaticojejunostomy after pancreaticoduodenectomy
Arm Title
invagination
Arm Type
Active Comparator
Arm Description
invagination technique is used for pancreaticojejunostomy after pancreaticoduodenectomy
Intervention Type
Procedure
Intervention Name(s)
duct-to-mucosa
Intervention Type
Procedure
Intervention Name(s)
invagination
Intervention Type
Device
Intervention Name(s)
Internal stent
Intervention Description
Internal stent may be used during pancreaticojejunostomy according to the situation of pancreatic duct and experience of the surgeon.
Primary Outcome Measure Information:
Title
pancreatic fistula
Description
The determine of pancreatic fistula follows the International Study Group on Pancreatic Fistulas (ISGPF) criteria.
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
Secondary Outcome Measure Information:
Title
Mortality
Description
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
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
Title
Morbidity
Description
any complications after operation will be recorded.
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
Title
Reoperation
Description
Reasons and times of reoperation are recorded. The attending doctor will decided Whether reoperation is needed, according to indications and his experience.
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
Title
Hospital stay
Description
Post-operation hospital stay is assessed.
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xue-Li Bai, Ph.D.
Phone
+86 571 87783510
Email
shirleybai57@hotmail.com
Facility Information:
Facility Name
the Second Affiliated Hospital, School of Medicine, Zhejiang Universtiy
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ting-Bo Liang, Ph.D., M.D.
Phone
+86 571 87783510
Email
liangtingbo@zju.edu.cn
12. IPD Sharing Statement
Citations:
PubMed Identifier
26577499
Citation
Bai X, Zhang Q, Gao S, Lou J, Li G, Zhang Y, Ma T, Zhang Y, Xu Y, Liang T. Duct-to-Mucosa vs Invagination for Pancreaticojejunostomy after Pancreaticoduodenectomy: A Prospective, Randomized Controlled Trial from a Single Surgeon. J Am Coll Surg. 2016 Jan;222(1):10-8. doi: 10.1016/j.jamcollsurg.2015.10.003. Epub 2015 Oct 21.
Results Reference
derived
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Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy
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