Chyle Leak After Pancreatic Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Chyle Leak After Pancreatic Surgery - CLAP

Conditions
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Postoperative Chyle Leak

Intervention / Treatment
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* Other: Standard care irrespective of CL
* Other: Dietary treatment (MCT-diet)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ignoring CL (group A)<br>Standard care irrespective of CL. | Other: Standard care irrespective of CL<br>* Removal of surgical drains despite persistent CL, without dietary restrictions or dietary treatment for CL.<br>|
| Active Comparator: Dietary treatment (group B)<br>Dietary treatment with medium-chain triglyceride diet (MCT-diet) until resolution of CL. | Other: Dietary treatment (MCT-diet)<br>* Dietary treatment with MCT-diet until resolution of CL.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative morbidity | Complications ≥ Clavien-Dindo3 grade IIIa | 30 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay at the hospital | The time spent at the hospital will be recorded | 90 days postoperatively | 
| Time until drain removal | The time until drain removal will be recorded | 30 days postoperatively | 
| Readmission to the hospital | Patients will be called and asked for any readmission to a hospital (yes /no) | 90 days postoperatively | 
| Weight change | Weight (Day before surgery) - Weight (10 days postoperatively) | The day before surgery until postoperative day 10 | 
| Body mass index (BMI) change | BMI (day before surgery) - BMI (10 days postoperatively) | The day before surgery until postoperative day 10 | 
| International normalized ration (INR) change | INR (Day before surgery) - INR (10 days postoperatively) | The day before surgery until postoperative day 10 | 
| Albumin change | Albumin level (Day before surgery) - Albumin level (10 days postoperatively) | The day before surgery until postoperative day 10 | 
| Postoperative cortisol level | Cortisol levels will be compared between group A and B | 8 days postoperatively | 
| Freiburg index of patient satisfaction | Patient satisfaction will be measured using a standardized questionnaire | Postoperative day 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic surgery, Chylous ascites