Chyle Leak After Pancreatic Operation
Observational Study in Chyle Leak After Pancreatic Operation
1 other identifier
observational
1,000
1 country
1
Brief Summary
With the development of pancreatic surgery, the surgeon has put more emphasis on chylous fistula as the postoperative complications in recent years. The diagnostic criteria and treatment methods about chylous leakage have been developed and improved in clinical practice. However, there remains controversy about the high risk factors and efficient control measures during the perioperative period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2017
CompletedFirst Posted
Study publicly available on registry
April 25, 2017
CompletedStudy Start
First participant enrolled
May 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedOctober 9, 2017
April 1, 2017
3 years
April 4, 2017
October 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Chylous fistula
The determine of chylous fistula follows the International Study Group on Pancreatic Fistulas (ISGPF) criteria.
From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days
Secondary Outcomes (4)
Extubation time
From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days
Hospital stays
From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days
Number of hospitalizations
From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days
Mortality
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
Study Arms (2)
CL group
Subjects who had CL after pancreatic operation will be observed.
Observation group
Subjects without CL after pancreatic operation will be observed.
Eligibility Criteria
Participants with diagnosed CL after pancreatic operation
You may qualify if:
- Must have a diagnosis of CL after pancreatic operation
- Aged 18 or older
- Of either sex
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
the second affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, 310009, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ting-Bo Liang, phD
Second Affiliated Hospital of Zhejiang University School of Medicine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2017
First Posted
April 25, 2017
Study Start
May 1, 2018
Primary Completion
May 1, 2021
Study Completion
May 1, 2021
Last Updated
October 9, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share