Aorta Abdominalis; AneurysmNCT06286540
Evaluation of the Efficacy and Safety of Surgical Device "Lymphoblock" for Prevention of Lymphorrhea in Patients With Thoracoabdominal Aorta Repair.
A study testing Lymphoblock in people with Aorta Abdominalis; Aneurysm and Aorta Thoracic; Aneurysm, run by Petrovsky National Research Centre of Surgery at 1 site in Russia.
Trial summary
Randomized, double-blind, placebo-controlled study will determine the clinical efficacy and safety of Lymphoblock in the prevention of postoperative retroperitoneal chylo-/lymphorrhoea in patients with open surgical treatment of the thoracoabdominal aorta. It is planned to recruit 138 clinical observations. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Aorta Abdominalis; Aneurysm, Aorta Thoracic; Aneurysm
- What is being tested?
- Lymphoblock
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 1 siteRussia
- Study dates
- 22 Feb 2023to May 2026
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient in thoracoabdominal or abdominal aorta repair underwent retroperitoneal aortic access
Who cannot join
- refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Petrovsky NRCS
Moscow, 119991
Denis Breshenkov, Phd, +79773439041, denisbreshenkov@gmail.com
Boris Tivelev, +79044244886, boristivelev@gmail.com
About this study
Official title: Efficacy and Safety of Lymphoblock in the Prevention of Postoperative Lymphorrhea After Surgical Treatment of the Thoracoabdominal Aorta: a Single-center, Randomized, Placebo-controlled, Double-blind Study.
Randomized, double-blind, placebo-controlled study will determine the clinical efficacy and safety of Lymphoblock in the prevention of postoperative retroperitoneal chylo-/lymphorrhoea in patients with open surgical treatment of the thoracoabdominal aorta. It is planned to recruit 138 clinical observations. Efficacy will be evaluated based on clinical and laboratory data.
Read the detailed description
The study design will include patients with open surgical repair of the thoracoabdominal aorta who underwent thoracophrenolumbotomy with retroperitoneal exposure of the aorta. It is assumed the lymphoblock to reduce the incidence of postoperative lympho-/chylorrhea. Patients will be divided based on randomization into groups that will receive a lymphoblock or a placebo. It is planned to recruit 138 patients, 69 patients in each group. The drug will be used right before wound closure. The solution will be applied to the surface of the wound with further exposure and draining. Blood test and drainage discharge parameters (from the left pleural cavity and retroperitoneum) will be examined in postoperative period. The thoracic and abdominal CT and ultrasound will be performed to exclude presence of effusion and/or lymphocele.
- Being tested
- Lymphoblock, Placebo
- Medical subject headings
- Aortic Aneurysm, Abdominal, Aortic Aneurysm, Thoracic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LymphoblockDevice
1 time per surgery with the exposition for 20 minutes.
PlaceboDevice
1 time per surgery with the exposition for 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Lymphoblock | Experimental | Patients from this group received Lymphoblock. Receives: Device: Lymphoblock |
| Placebo | Placebo comparator | Patients from this group received placebo. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Chylous Effusion (Сhilo-/lymphorrhea)
This outcome will be determined by assessing the milky of the drainage discharge, and comparing the content of triglycerides, glucose, cholesterol and lactate dehydrogenase (LDH) in the drainage discharge with those in the blood plasma
Measured: within 10 days of starting a regular diet after surgery
Number of Participants with Lymphocele
retroperitoneal liquid formation ≥5 cm in diameter according to ultrasound after drainage removal
Measured: 10 days after the surgery in patient who starting a regular diet after drainage removal
Secondary outcomes (18)
The amount of drainage discharge 1
volume of drainage discharge obtained in the first 24 hours after surgery, measured in milliliters (ml)
Measured: 24 hours after the surgery
The amount of drainage discharge 2
volume of drainage discharge obtained in the first 48 hours after surgery, measured in milliliters (ml)
Measured: 48 hours after the surgery
The amount of drainage discharge 3
volume of drainage discharge obtained in the first 72 hours after surgery, (ml)
Measured: 72 hours after the surgery
Concentration of triglycerides in the drainage discharge
count of triglycerides in the drainage discharge, received from drainage tube, (mg/dL)
Measured: 72 hours after the surgery
Concentration of triglycerides in blood plasma
count of triglycerides in the blood plasma, (mg/dL)
Measured: 72 hours after the surgery
Concentration of cholesterol in the drainage discharge
count of cholesterol in the drainage discharge, received from drainage tube, (mg/dL)
Measured: 72 hours after the surgery
Concentration of cholesterol in the blood plasma
count of cholesterol in the blood plasma, (mg/dL)
Measured: 72 hours after the surgery
Concentration of protein in the drainage discharge
count of total protein in the drainage discharge, received from drainage tube, (g/dL)
Measured: 72 hours after the surgery
Concentration of protein in the blood plasma
count of total protein in the blood plasma, (g/dL)
Measured: 72 hours after the surgery
Concentration of albumin in the drainage discharge
count of albumin in the drainage discharge, received from drainage tube, (g/dL)
Measured: 72 hours after the surgery
Concentration of albumin in the blood plasma
count of albumin in the blood plasma, (g/dL)
Measured: 72 hours after the surgery
Concentration of lactate dehydrogenase in the drainage discharge
count of albumin in the drainage discharge, received from drainage tube (IU/L)
Measured: 72 hours after the surgery
Concentration of lactate dehydrogenase in the blood plasma
count of lactate dehydrogenase in the blood plasma (IU/L)
Measured: 72 hours after the surgery
Concentration of glucose in the drainage discharge
Content of glucose in the drainage discharge, received from drainage tube, (mg/dL)
Measured: 72 hours after the surgery
Concentration of glucose in the blood plasma
Content of glucose in the blood plasma (mg/dL)
Measured: 72 hours after the surgery
Number of Participants with Pleural effusion within 10 days
left pleural fluid accumulations (≥500 ml) after drainage removal drainage removal
Measured: 10 days after the surgery in patient who starting a regular diet after drainage removal
Number of Participants with Lymphocele 3 months after the surgery
liquid formation ≥5 cm in diameter according to ultrasound after drainage removal
Measured: 3 months after the surgery
Number of Participants with Pleural effusion 3 months after the surgery
left pleural fluid accumulations (≥500 ml) after drainage removal
Measured: 3 months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start22 Feb 2023
- Primary completionFeb 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aorta Abdominalis; AneurysmStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Petrovsky National Research Centre of Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eduard Charchyan, MD, Principal investigator, Petrovsky NRCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286540
- Sponsor's protocol ID
- 26031993
- Status last verified
- Mar 2024
- First submitted
- 22 Feb 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Lymphoblock in the Prevention of Postoperative Lymphorrhea After Surgical Treatment of the Thoracoabdominal Aorta: a Single-center, Randomized, Placebo-controlled, Double-blind Study.
- ClinicalTrials.gov ID
- NCT06286540
- Acronym / sponsor ID
- 26031993
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Petrovsky National Research Centre of SurgeryUniversity, hospital or other
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 29 Feb 2024 (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.
Randomized, double-blind, placebo-controlled study will determine the clinical efficacy and safety of Lymphoblock in the prevention of postoperative retroperitoneal chylo-/lymphorrhoea in patients with open surgical treatment of the thoracoabdominal aorta. It is planned to recruit 138 clinical observations. Efficacy will be evaluated based on clinical and laboratory data.
Detailed description
The study design will include patients with open surgical repair of the thoracoabdominal aorta who underwent thoracophrenolumbotomy with retroperitoneal exposure of the aorta. It is assumed the lymphoblock to reduce the incidence of postoperative lympho-/chylorrhea. Patients will be divided based on randomization into groups that will receive a lymphoblock or a placebo. It is planned to recruit 138 patients, 69 patients in each group. The drug will be used right before wound closure. The solution will be applied to the surface of the wound with further exposure and draining. Blood test and drainage discharge parameters (from the left pleural cavity and retroperitoneum) will be examined in postoperative period. The thoracic and abdominal CT and ultrasound will be performed to exclude presence of effusion and/or lymphocele.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lymphoblock | Experimental | Device: LymphoblockPatients from this group received Lymphoblock. |
| Placebo | Placebo comparator | Device: PlaceboPatients from this group received placebo. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient in thoracoabdominal or abdominal aorta repair underwent retroperitoneal aortic access
Key exclusion criteria (1 listed)
- refusal to participate in the study
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 |
|---|---|---|
| Lymphoblock1 time per surgery with the exposition for 20 minutes. | Device | Lymphoblock |
| Placebo1 time per surgery with the exposition for 20 minutes. | Device | Placebo |
Primary outcome
Number of Participants with Chylous Effusion (Сhilo-/lymphorrhea)
Time frame: within 10 days of starting a regular diet after surgery
This outcome will be determined by assessing the milky of the drainage discharge, and comparing the content of triglycerides, glucose, cholesterol and lactate dehydrogenase (LDH) in the drainage discharge with those in the blood plasma
Number of Participants with Lymphocele
Time frame: 10 days after the surgery in patient who starting a regular diet after drainage removal
retroperitoneal liquid formation ≥5 cm in diameter according to ultrasound after drainage removal
18 secondary outcomes
The amount of drainage discharge 1
Time frame: 24 hours after the surgery
The amount of drainage discharge 2
Time frame: 48 hours after the surgery
The amount of drainage discharge 3
Time frame: 72 hours after the surgery
Concentration of triglycerides in the drainage discharge
Time frame: 72 hours after the surgery
Concentration of triglycerides in blood plasma
Time frame: 72 hours after the surgery
Concentration of cholesterol in the drainage discharge
Time frame: 72 hours after the surgery
Concentration of cholesterol in the blood plasma
Time frame: 72 hours after the surgery
Concentration of protein in the drainage discharge
Time frame: 72 hours after the surgery
Concentration of protein in the blood plasma
Time frame: 72 hours after the surgery
Concentration of albumin in the drainage discharge
Time frame: 72 hours after the surgery
Concentration of albumin in the blood plasma
Time frame: 72 hours after the surgery
Concentration of lactate dehydrogenase in the drainage discharge
Time frame: 72 hours after the surgery
Concentration of lactate dehydrogenase in the blood plasma
Time frame: 72 hours after the surgery
Concentration of glucose in the drainage discharge
Time frame: 72 hours after the surgery
Concentration of glucose in the blood plasma
Time frame: 72 hours after the surgery
Number of Participants with Pleural effusion within 10 days
Time frame: 10 days after the surgery in patient who starting a regular diet after drainage removal
Number of Participants with Lymphocele 3 months after the surgery
Time frame: 3 months after the surgery
Number of Participants with Pleural effusion 3 months after the surgery
Time frame: 3 months after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Eduard Charchyan, MD principal investigator
Petrovsky NRCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lymphoblock in people with Aorta Abdominalis; Aneurysm and Aorta Thoracic; Aneurysm, run by Petrovsky National Research Centre of Surgery at 1 site in Russia.
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 1 inclusion and 1 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 Mar 2024. 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 Russia. 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. Some participants in this study may receive a placebo. 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 Eduard Charchyan, MD (+79262174114, charchmed@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Chylous Effusion (Сhilo-/lymphorrhea) (time frame: within 10 days of starting a regular diet after surgery). The study lists 2 primary outcomes in all. 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 Mar 2024.