Chyle Leak After Pancreatic Operation

Pancreatic Cancer Clinical Trial

Official title:

Observational Study in Chyle Leak After Pancreatic Operation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03127150
• Other study ID #: SAHZhejiangU05
• Status: Not yet recruiting
• Phase: N/A
• First received: April 4, 2017
• Last updated: October 5, 2017
• Start date: May 1, 2018
• Est. completion date: May 1, 2021

Study information

• Verified date: April 2017
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Xue-Li Bai, phD
• Phone: +86 571 87783510
• Email: shirleybai57[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Locations

Country	Name	City	State
China	the second affiliated hospital of Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Extubation time	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
Secondary	Hospital stays	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
Secondary	Number of hospitalizations	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
Secondary	Mortality	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