Clinical trial NCT03079986: Chyle Leak After Pancreatic Surgery
Official title: Chyle Leak After Pancreatic Surgery - CLAP
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Chyle Leak
Keywords: Pancreatic surgery
Chylous ascites
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2017-03-15
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative morbidity
timeFrame: 30 days postoperatively
Secondary outcomes:
measure: Length of stay at the hospital
timeFrame: 90 days postoperatively
measure: Time until drain removal
timeFrame: 30 days postoperatively
measure: Readmission to the hospital
timeFrame: 90 days postoperatively
measure: Weight change
timeFrame: The day before surgery until postoperative day 10
measure: Body mass index (BMI) change
timeFrame: The day before surgery until postoperative day 10
measure: International normalized ration (INR) change
timeFrame: The day before surgery until postoperative day 10
measure: Albumin change
timeFrame: The day before surgery until postoperative day 10
measure: Postoperative cortisol level
timeFrame: 8 days postoperatively
measure: Freiburg index of patient satisfaction
timeFrame: Postoperative day 10
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Ludwig-Maximilians-University
Study officials:
affiliation: Ludwig-Maximilians - University of Munich
name: Jan D'Haese, M.D.
role: PRINCIPAL_INVESTIGATOR
References: