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Chyle Leak After Pancreatic Operation

Zhejiang University logo

Zhejiang University

Status

Unknown

Conditions

Pancreatic Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT03127150
SAHZhejiangU05

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

1,000 participants in 2 patient groups

CL group
Description:
Subjects who had CL after pancreatic operation will be observed.
Observation group
Description:
Subjects without CL after pancreatic operation will be observed.

Trial contacts and locations

1

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Central trial contact

Xue-Li Bai, phD

Data sourced from clinicaltrials.gov

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