Chyle Leak After Pancreatic Surgery (CLAP)

Chyle Leak After Pancreatic Surgery - CLAP

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Chyle Leak
• Intervention / Treatment: Other: Standard care irrespective of CL; Other: Dietary treatment (MCT-diet)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany
    • Recruiting
    • Ludwig-Maximilians-University
    • Contact: Jan D'Haese, MD; Phone Number: 00494400712210; Email: jan.dhaese@med.uni-muenchen.de
    • Contact: Maximilian Weniger, MD; Phone Number: 00494400712205; Email: maximilian.weniger@med.uni-muenchen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ludwig-Maximilians - University of Munich
• Investigators: Principal Investigator: Jan D'Haese, M.D., Ludwig-Maximilians - University of Munich

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2017
• Primary Completion (Anticipated): April 30, 2021
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: February 25, 2017
• First Submitted That Met QC Criteria: March 14, 2017
• First Posted (Actual): March 15, 2017

Study Record Updates

• Last Update Posted (Actual): August 15, 2018
• Last Update Submitted That Met QC Criteria: August 13, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Pancreatic surgery; Chylous ascites
• Other Study ID Numbers: CLAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No