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2018-05-01
2021-05-01
2021-05-01
1000
NCT03127150
Second Affiliated Hospital, School of Medicine, Zhejiang University
Second Affiliated Hospital, School of Medicine, Zhejiang University
OBSERVATIONAL
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.
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.
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2017-04-04 | N/A | 2017-10-05 |
2017-04-23 | N/A | 2017-10-09 |
2017-04-25 | N/A | 2017-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : CL group Subjects who had CL after pancreatic operation will be observed. | |
| : Observation group Subjects without CL after pancreatic operation will be observed. |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Xue-Li Bai, phD Phone Number: +86 571 87783510 Email: shirleybai57@hotmail.com |
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
