Chyle Leak After Pancreatic Operation

NCT ID: NCT03127150

Last Updated: 2017-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-01

Study Completion Date

2021-05-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pancreatic Cancer

Keywords

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Chylous leakage Diagnostic criteria Pancreas surgery Therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CL group

Subjects who had CL after pancreatic operation will be observed.

No interventions assigned to this group

Observation group

Subjects without CL after pancreatic operation will be observed.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Must have a diagnosis of CL after pancreatic operation
* Aged 18 or older
* Of either sex
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ting-Bo Liang, phD

Role: STUDY_CHAIR

Second Affiliated Hospital of Zhejiang University School of Medicine

Locations

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the second affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Central Contacts

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Xue-Li Bai, phD

Role: CONTACT

Phone: +86 571 87783510

Email: [email protected]

Other Identifiers

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SAHZhejiangU05

Identifier Type: -

Identifier Source: org_study_id