Chyle Leak After Pancreatic Surgery
- Conditions
- Postoperative Chyle Leak
- Interventions
- Other: Standard care irrespective of CLOther: Dietary treatment (MCT-diet)
- Registration Number
- NCT03079986
- Lead Sponsor
- Ludwig-Maximilians - University of Munich
- Brief Summary
Currently it is unclear whether postoperative chyle leak (CL) after pancreatic surgery requires treatment. Thus, the present study aims to compare dietary treatment of CL with drain removal despite of persistent CL.
- Detailed Description
With an incidence of up to 11%, postoperative chyle leak (CL) is a frequent phenomenon after pancreatic surgery, where extensive lymph node dissections are indispensable. Postoperative CL is frequently treated with either medium-chain triglyceride diet (MCT-diet) or total parenteral nutrition (TPN). Ignoring CL and removing the surgical drains irrespective of CL may also be discussed. While dietary restrictions are known to hinder postoperative convalescence and prolong the length of stay at the hospital, recent retrospective data show that leaving CL untreated is not associated with an increased morbidity rate. More precisely, removing the surgical drains irrespective of CL does not result in an increased incidence of CT-guided drainages. However, prospective data on CL after pancreatic surgery do not exist in the literature. Accordingly, the present trial aims to compare treatment of CL with dietary restrictions to removing the surgical drains irrespective of CL.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 86
- Written informed consent
- Pancreatic surgery of any kind
- Liver cirrhosis > Child-Pugh grade A
- History of portal vein thrombosis
- Portal Hypertension
Dropout Criteria:
- Irresectable Tumor (no surgical resection)
- Biochemical leak or postoperative pancreatic fistula (POPF)5
- Serous drainage on POD 5
- Peritoneal carcinomatosis
- Portal vein thrombosis
- Postoperative bile leak
- Drain volume >1000ml on POD5
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ignoring CL (group A) Standard care irrespective of CL Standard care irrespective of CL. Dietary treatment (group B) Dietary treatment (MCT-diet) Dietary treatment with medium-chain triglyceride diet (MCT-diet) until resolution of CL.
- Primary Outcome Measures
Name Time Method Postoperative morbidity 30 days postoperatively Complications ≥ Clavien-Dindo3 grade IIIa
- Secondary Outcome Measures
Name Time Method Length of stay at the hospital 90 days postoperatively The time spent at the hospital will be recorded
Time until drain removal 30 days postoperatively The time until drain removal will be recorded
Readmission to the hospital 90 days postoperatively Patients will be called and asked for any readmission to a hospital (yes /no)
Weight change The day before surgery until postoperative day 10 Weight (Day before surgery) - Weight (10 days postoperatively)
Body mass index (BMI) change The day before surgery until postoperative day 10 BMI (day before surgery) - BMI (10 days postoperatively)
International normalized ration (INR) change The day before surgery until postoperative day 10 INR (Day before surgery) - INR (10 days postoperatively)
Albumin change The day before surgery until postoperative day 10 Albumin level (Day before surgery) - Albumin level (10 days postoperatively)
Postoperative cortisol level 8 days postoperatively Cortisol levels will be compared between group A and B
Freiburg index of patient satisfaction Postoperative day 10 Patient satisfaction will be measured using a standardized questionnaire
Trial Locations
- Locations (1)
Ludwig-Maximilians-University
🇩🇪Munich, Germany