Clinical trial NCT03127150: Chyle Leak After Pancreatic Operation
Official title: Observational Study in Chyle Leak After Pancreatic Operation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Cancer
Keywords: Chylous leakage
Diagnostic criteria
Pancreas surgery
Therapy
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2017-04-25
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with diagnosed CL after pancreatic operation

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Chylous fistula
timeFrame: 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:
measure: Extubation time
timeFrame: From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days
measure: Hospital stays
timeFrame: From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days
measure: Number of hospitalizations
timeFrame: From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days
measure: Mortality
timeFrame: 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
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the second affiliated hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital of Zhejiang University School of Medicine
name: Ting-Bo Liang, phD
role: STUDY_CHAIR
References: