Trials / Unknown
UnknownNCT03079986
Chyle Leak After Pancreatic Surgery
Chyle Leak After Pancreatic Surgery - CLAP
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 86 (estimated)
- Sponsor
- Ludwig-Maximilians - University of Munich · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Standard care irrespective of CL | Removal of surgical drains despite persistent CL, without dietary restrictions or dietary treatment for CL. |
| OTHER | Dietary treatment (MCT-diet) | Dietary treatment with MCT-diet until resolution of CL. |
Timeline
- Start date
- 2017-05-31
- Primary completion
- 2021-04-30
- Completion
- 2021-06-30
- First posted
- 2017-03-15
- Last updated
- 2018-08-15
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT03079986. Inclusion in this directory is not an endorsement.