Chyle Leak After Pancreatic Operation

October 5, 2017 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

Observational Study in Chyle Leak After Pancreatic Operation

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

Chylous fistula is one of the common complications after pancreatic operation, whose incidence is about 10%. The delayed diagnosis or wrong treatment in the perioperative period may lead to refractory chylous ascites, water-electrolyte imbalance, malnutrition, immune dysfunction, secondary infection and other complications. In the past, chylous fistula, as the postoperative complication, is common in abdominal aortic surgery, gynecological malignancies accompanied with posterior peritoneum lymphadenectomy and spinal surgery, etc. But chylous fistula after pancreatic operation did not attract enough attention. The comparative study or case analysis is lacked in relevant reports and there is no consensus on diagnostic criteria. In addition, once it occurs after pancreatic operation, the rehabilitation of patients will be affected, increasing the burden of hospitalization and even endangering the lives of patients due to the lack of diagnosis and treatment experience of specialists. The International Study Group of Pancreatic Surgery (ISGPS) proposed relevant definitions under the background of no unified diagnostic criteria of chylous fistula after pancreatic operation. But this definition still has some shortcomings; for example, it lacks the value of clinical guidance and research implementation. Moreover, how to take targeted preventive measures, choose the optimal treatment method and avoid complications, and whether there is a superior treatment method need to be further considered and investigated. Therefore, we performed this study, so as to better improve the relevant definition and provide guidance for the diagnosis and treatment.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • The second affiliated hospital of Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants with diagnosed CL after pancreatic operation

Description

Inclusion Criteria:

  • Must have a diagnosis of CL after pancreatic operation
  • Aged 18 or older
  • Of either sex

Exclusion Criteria:

  • No specific exclusion criteria will be applied to a participant as long as the participant is eligible for the trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
CL group
Subjects who had CL after pancreatic operation will be observed.
Observation group
Subjects without CL after pancreatic operation will be observed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chylous fistula
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extubation time
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
The time of removing the drainage tube
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
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
the time during the operation to hospital discharge
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
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
Number of hospitalizations during the observational period
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
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
Postoperative death in 30 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 1, 2018

Primary Completion (ANTICIPATED)

May 1, 2021

Study Completion (ANTICIPATED)

May 1, 2021

Study Registration Dates

First Submitted

April 4, 2017

First Submitted That Met QC Criteria

April 23, 2017

First Posted (ACTUAL)

April 25, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 9, 2017

Last Update Submitted That Met QC Criteria

October 5, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SAHZhejiangU05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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