Chyle Leak After Pancreatic Surgery

Postoperative Chyle Leak Clinical Trial

— CLAP  

Official title:

Chyle Leak After Pancreatic Surgery - CLAP

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03079986
• Other study ID #: CLAP
• Status: Recruiting
• Phase: N/A
• Start date: May 31, 2017
• Est. completion date: June 30, 2021

Study information

• Verified date: August 2018
• Source: Ludwig-Maximilians - University of Munich
• Contact: Jan D'Haese, M.D.
• Phone: +49894400712210
• Email: jan.dhaese[@]med.uni-muenchen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: June 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Chyle Leak

Intervention

Other:
• Standard care irrespective of CL
Removal of surgical drains despite persistent CL, without dietary restrictions or dietary treatment for CL.
• Dietary treatment (MCT-diet)
Dietary treatment with MCT-diet until resolution of CL.

Locations

Country	Name	City	State
Germany	Ludwig-Maximilians-University	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative morbidity	Complications = Clavien-Dindo3 grade IIIa	30 days postoperatively
Secondary	Length of stay at the hospital	The time spent at the hospital will be recorded	90 days postoperatively
Secondary	Time until drain removal	The time until drain removal will be recorded	30 days postoperatively
Secondary	Readmission to the hospital	Patients will be called and asked for any readmission to a hospital (yes /no)	90 days postoperatively
Secondary	Weight change	Weight (Day before surgery) - Weight (10 days postoperatively)	The day before surgery until postoperative day 10
Secondary	Body mass index (BMI) change	BMI (day before surgery) - BMI (10 days postoperatively)	The day before surgery until postoperative day 10
Secondary	International normalized ration (INR) change	INR (Day before surgery) - INR (10 days postoperatively)	The day before surgery until postoperative day 10
Secondary	Albumin change	Albumin level (Day before surgery) - Albumin level (10 days postoperatively)	The day before surgery until postoperative day 10
Secondary	Postoperative cortisol level	Cortisol levels will be compared between group A and B	8 days postoperatively
Secondary	Freiburg index of patient satisfaction	Patient satisfaction will be measured using a standardized questionnaire	Postoperative day 10