Postoperative Chyle Leak
Conditions
Keywords
Pancreatic surgery, Chylous ascites
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.
Interventions
OTHERStandard care irrespective of CL
Removal of surgical drains despite persistent CL, without dietary restrictions or dietary treatment for CL.
OTHERDietary treatment (MCT-diet)
Dietary treatment with MCT-diet until resolution of CL.
Sponsors
Ludwig-Maximilians - University of Munich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent * Pancreatic surgery of any kind
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative morbidity | 30 days postoperatively | Complications ≥ Clavien-Dindo3 grade IIIa |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Length of stay at the hospital | 90 days postoperatively | The time spent at the hospital will be recorded |
| 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 |
| International normalized ration (INR) change | The day before surgery until postoperative day 10 | INR (Day before surgery) - INR (10 days postoperatively) |
Countries
Germany
Contacts
Primary ContactJan D'Haese, M.D.
Outcome results
None listed