Chyle Leak After Pancreatic Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-31

Study Completion Date

2021-06-30

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.

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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.

Conditions

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Postoperative Chyle Leak

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ignoring CL (group A)

Standard care irrespective of CL.

Group Type EXPERIMENTAL

Standard care irrespective of CL

Intervention Type OTHER

Removal of surgical drains despite persistent CL, without dietary restrictions or dietary treatment for CL.

Dietary treatment (group B)

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

Group Type ACTIVE_COMPARATOR

Dietary treatment (MCT-diet)

Intervention Type OTHER

Dietary treatment with MCT-diet until resolution of CL.

Interventions

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Standard care irrespective of CL

Removal of surgical drains despite persistent CL, without dietary restrictions or dietary treatment for CL.

Intervention Type OTHER

Dietary treatment (MCT-diet)

Dietary treatment with MCT-diet until resolution of CL.

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No