Postoperative Chyle LeakCLAPNCT03079986
Chyle Leak After Pancreatic Surgery
A study testing Dietary treatment (MCT-diet) in people with Postoperative Chyle Leak, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Chyle Leak
- What is being tested?
- Dietary treatment (MCT-diet)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteGermany
- Study dates
- 31 May 2017to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Pancreatic surgery of any kind
Who cannot join
- 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
Show all 11Show fewer
- Serous drainage on POD 5
- Peritoneal carcinomatosis
- Portal vein thrombosis
- Postoperative bile leak
- Drain volume >1000ml on POD5
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Ludwig-Maximilians-University
Munich
Jan D'Haese, MD, 00494400712210, jan.dhaese@med.uni-muenchen.de
Maximilian Weniger, MD, 00494400712205, maximilian.weniger@med.uni-muenchen.de
About this study
Official title: Chyle Leak After Pancreatic Surgery - CLAP
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.
Read the 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
- Postoperative Chyle Leak
- Being tested
- Standard care irrespective of CL, Dietary treatment (MCT-diet)
- Keywords
- Pancreatic surgery, Chylous ascites
- Medical subject headings
- Chylous Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard care irrespective of CLOther
Removal of surgical drains despite persistent CL, without dietary restrictions or dietary treatment for CL.
Dietary treatment (MCT-diet)Other
Dietary treatment with MCT-diet until resolution of CL.
| Study group | Role | What they receive |
|---|---|---|
| Ignoring CL (group A) | Experimental | Standard care irrespective of CL. Receives: Other: Standard care irrespective of CL |
| Dietary treatment (group B) | Active comparator | Dietary treatment with medium-chain triglyceride diet (MCT-diet) until resolution of CL. Receives: Other: Dietary treatment (MCT-diet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative morbidity
Complications ≥ Clavien-Dindo3 grade IIIa
Measured: 30 days postoperatively
Secondary outcomes (9)
Length of stay at the hospital
The time spent at the hospital will be recorded
Measured: 90 days postoperatively
Time until drain removal
The time until drain removal will be recorded
Measured: 30 days postoperatively
Readmission to the hospital
Patients will be called and asked for any readmission to a hospital (yes /no)
Measured: 90 days postoperatively
Weight change
Weight (Day before surgery) - Weight (10 days postoperatively)
Measured: The day before surgery until postoperative day 10
Body mass index (BMI) change
BMI (day before surgery) - BMI (10 days postoperatively)
Measured: The day before surgery until postoperative day 10
International normalized ration (INR) change
INR (Day before surgery) - INR (10 days postoperatively)
Measured: The day before surgery until postoperative day 10
Albumin change
Albumin level (Day before surgery) - Albumin level (10 days postoperatively)
Measured: The day before surgery until postoperative day 10
Postoperative cortisol level
Cortisol levels will be compared between group A and B
Measured: 8 days postoperatively
Freiburg index of patient satisfaction
Patient satisfaction will be measured using a standardized questionnaire
Measured: Postoperative day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start31 May 2017
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Chyle LeakStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan D'Haese, Ludwig-Maximilians - University of Munich
- Investigators
- Jan D'Haese, M.D., Principal investigator, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079986
- Sponsor's protocol ID
- CLAP
- Acronym
- CLAP
- Status last verified
- Aug 2018
- First submitted
- 25 Feb 2017
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chyle Leak After Pancreatic Surgery - CLAP
- ClinicalTrials.gov ID
- NCT03079986
- Acronym / sponsor ID
- CLAP / CLAP
- Conditions
- Postoperative Chyle Leak
- Keywords
- Pancreatic surgery, Chylous ascites
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- 31 May 2017 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 15 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ignoring CL (group A) | Experimental | Other: Standard care irrespective of CLStandard care irrespective of CL. |
| Dietary treatment (group B) | Active comparator | Other: Dietary treatment (MCT-diet)Dietary treatment with medium-chain triglyceride diet (MCT-diet) until resolution of CL. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Written informed consent
- Pancreatic surgery of any kind
Key exclusion criteria (11 listed)
- Liver cirrhosis > Child-Pugh grade A
- History of portal vein thrombosis
- Portal Hypertension
- Irresectable Tumor (no surgical resection)
- Biochemical leak or postoperative pancreatic fistula (POPF)5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard care irrespective of CLRemoval of surgical drains despite persistent CL, without dietary restrictions or dietary treatment for CL. | Other | Ignoring CL (group A) |
| Dietary treatment (MCT-diet)Dietary treatment with MCT-diet until resolution of CL. | Other | Dietary treatment (group B) |
Primary outcome
Postoperative morbidity
Time frame: 30 days postoperatively
Complications ≥ Clavien-Dindo3 grade IIIa
9 secondary outcomes
Length of stay at the hospital
Time frame: 90 days postoperatively
Time until drain removal
Time frame: 30 days postoperatively
Readmission to the hospital
Time frame: 90 days postoperatively
Weight change
Time frame: The day before surgery until postoperative day 10
Body mass index (BMI) change
Time frame: The day before surgery until postoperative day 10
International normalized ration (INR) change
Time frame: The day before surgery until postoperative day 10
Albumin change
Time frame: The day before surgery until postoperative day 10
Postoperative cortisol level
Time frame: 8 days postoperatively
Freiburg index of patient satisfaction
Time frame: Postoperative day 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan D'Haese, M.D. principal investigator
Ludwig-Maximilians - University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary treatment (MCT-diet) in people with Postoperative Chyle Leak, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan D'Haese, M.D. (+49894400712210, jan.dhaese@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative morbidity (time frame: 30 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2018.