Chyle Leak After Pancreatic Surgery (CLAP)

Ludwig Maximilian University of Munich

Status: Unknown

Conditions: Postoperative Chyle Leak

Treatments: Other: Standard care irrespective of CL; Other: Dietary treatment (MCT-diet)

Study type: Interventional

Funder types: Other

Identifiers

NCT03079986

CLAP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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86 participants in 2 patient groups

Ignoring CL (group A)

Experimental group

Description:

Standard care irrespective of CL.

Treatment:

Other: Standard care irrespective of CL

Dietary treatment (group B)

Active Comparator group

Description:

Dietary treatment with medium-chain triglyceride diet (MCT-diet) until resolution of CL.

Treatment:

Other: Dietary treatment (MCT-diet)