EsophagectomyERASME ULBNCT06563557
Erasme Randomized Controlled Trial Surveys Hemodynamic Excursions During Esophagectomy
A study testing Hemodynamic changes between epidural and paravertebral during esophagectomy in people with Esophagectomy and Epidural; Anesthesia, run by Erasme University Hospital.
Trial summary
In our high volume center, the majority of esophagectomy procedures are performed with minimally invasive techniques. The thoracic epidural technique remains the gold standard and homolateral paravertebral catheter is strongly recommended. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophagectomy, Epidural; Anesthesia, Paravertebral Anesthesia
- What is being tested?
- Hemodynamic changes between epidural and paravertebral during esophagectomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to 12 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adult, Capable of giving consent, two or three incisions esophagectomy (thoracoscopic/ thoracotomy) no laparotomy
Who cannot join
- patient refusal, total language barrier, coagulation disorders, thrombocytopenia <75 000, contraindications to locoregional anesthesia (infection local site, allergy to local anesthesic), scoliosis Cobb > 45%, atrial fibrillation, end stage renal disease),
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: ERASME ULB: Erasme Randomized Controlled Trial Surveys Hemodynamic Excursions During Esophagectomy - a Double Blind Study
In our high volume center, the majority of esophagectomy procedures are performed with minimally invasive techniques. The thoracic epidural technique remains the gold standard and homolateral paravertebral catheter is strongly recommended. The vasoplegia and sympathetic blockade due to the epidural can cause significant hypotension especially as reverse Trendelenburg position is required during surgery. The aim is to study hemodynamic changes caused by two different techniques. Previous studies found a similar pain management between both locoregional techniques, however few studies suggested less side effects in the paravertebral group during major abdominal surgeries.
- Being tested
- Hemodynamic changes between epidural and paravertebral during esophagectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemodynamic changes between epidural and paravertebral during esophagectomyOther
The thoracic epidural technique remains the gold standard for perioperative pain management for this procedure. The placement of a paravertebral catheter homolateral with the thoracic incisions is strongly recommended. A goal directed fluid therapy is proposed to guide fluid management and limit postoperative complications. Few studies suggested less side effects in the paravertebral group. The vasoplegia due to the epidural can cause significant hypotension especially as reverse Trendelenburg position is required during surgery. The aim is to bring more light to the hemodynamic changes caused by two different locoregional techniques. An algorithm for fluid and vasopressor management has been proposed. We defined hypotension as 20% of decrement of the median arterial pressure during anesthesia. To reduce bias, the locoregional techniques is performed by an experienced anesthesiologists and the rest of the perioperative management is conducted by another blinded anesthesiologist.
| Study group | Role | What they receive |
|---|---|---|
| Epidural group | Active comparator | Not described Receives: Other: Hemodynamic changes between epidural and paravertebral during esophagectomy |
| Paravertebral group | Experimental | Not described Receives: Other: Hemodynamic changes between epidural and paravertebral during esophagectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consumption of norepinephrine and fluids during procedure
norepinephrine mcg/kg/hr
Measured: 6 hours
Secondary outcomes (1)
Postoperative complications
Medical complications: Pneumonia, atrial fibrillation, thromboembolic event Surgical complications : Wound dehiscence, anastomotic leakage, chylothorax, recurrent laryngeal nerve injury
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study startAug 2024 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion12 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for EsophagectomyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laszlo SZEGEDI, PHD, Study chair, Laszlo.szegedi@hubruxelles.be
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563557
- Sponsor's protocol ID
- P2023/514 /B4062024000032
- Acronym
- ERASME ULB
- Status last verified
- Jun 2024
- First submitted
- 19 Aug 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Low DE, Allum W, De Manzoni G, Ferri L, Immanuel A, Kuppusamy M, Law S, Lindblad M, Maynard N, Neal J, Pramesh CS, Scott M, Mark Smithers B, Addor V, Ljungqvist O. Guidelines for Perioperative Care in Esophagectomy: Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations. World J Surg. 2019 Feb;43(2):299-330. doi: 10.1007/s00268-018-4786-4.
PubMed 30276441Deana C, Vetrugno L, Bignami E, Bassi F. Peri-operative approach to esophagectomy: a narrative review from the anesthesiological standpoint. J Thorac Dis. 2021 Oct;13(10):6037-6051. doi: 10.21037/jtd-21-940.
PubMed 34795950Kingma BF, Eshuis WJ, de Groot EM, Feenstra ML, Ruurda JP, Gisbertz SS, Ten Hoope W, Marsman M, Hermanides J, Hollmann MW, Kalkman CJ, Luyer MDP, Nieuwenhuijzen GAP, Scholten HJ, Buise M, van Det MJ, Kouwenhoven EA, van der Meer F, Frederix GWJ, Cheong E, Al Naimi K, van Berge Henegouwen MI, van Hillegersberg R. Paravertebral catheter versus EPidural analgesia in Minimally invasive Esophageal resectioN: a randomized controlled multicenter trial (PEPMEN trial). BMC Cancer. 2020 Feb 22;20(1):142. doi: 10.1186/s12885-020-6585-1.
PubMed 32087686van den Berg JW, Tabrett K, Cheong E. Paravertebral catheter analgesia for minimally invasive Ivor Lewis oesophagectomy. J Thorac Dis. 2019 Apr;11(Suppl 5):S786-S793. doi: 10.21037/jtd.2019.03.47.
PubMed 31080659Yeung JH, Gates S, Naidu BV, Wilson MJ, Gao Smith F. Paravertebral block versus thoracic epidural for patients undergoing thoracotomy. Cochrane Database Syst Rev. 2016 Feb 21;2(2):CD009121. doi: 10.1002/14651858.CD009121.pub2.
PubMed 26897642
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ERASME ULB: Erasme Randomized Controlled Trial Surveys Hemodynamic Excursions During Esophagectomy - a Double Blind Study
- ClinicalTrials.gov ID
- NCT06563557
- Acronym / sponsor ID
- ERASME ULB / P2023/514 /B4062024000032
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 12 Dec 2026 (estimated)
- First posted
- 21 Aug 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.
In our high volume center, the majority of esophagectomy procedures are performed with minimally invasive techniques. The thoracic epidural technique remains the gold standard and homolateral paravertebral catheter is strongly recommended. The vasoplegia and sympathetic blockade due to the epidural can cause significant hypotension especially as reverse Trendelenburg position is required during surgery. The aim is to study hemodynamic changes caused by two different techniques. Previous studies found a similar pain management between both locoregional techniques, however few studies suggested less side effects in the paravertebral group during major abdominal surgeries.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural group | Active comparator | Other: Hemodynamic changes between epidural and paravertebral during esophagectomy |
| Paravertebral group | Experimental | Other: Hemodynamic changes between epidural and paravertebral during esophagectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult, Capable of giving consent, two or three incisions esophagectomy (thoracoscopic/ thoracotomy) no laparotomy
Key exclusion criteria (1 listed)
- patient refusal, total language barrier, coagulation disorders, thrombocytopenia <75 000, contraindications to locoregional anesthesia (infection local site, allergy to local anesthesic), scoliosis Cobb > 45%, atrial fibrillation, end stage renal disease),
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 |
|---|---|---|
| Hemodynamic changes between epidural and paravertebral during esophagectomyThe thoracic epidural technique remains the gold standard for perioperative pain management for this procedure. The placement of a paravertebral catheter homolateral with the thoracic incisions is strongly recommended. A goal directed fluid therapy is proposed to guide fluid management and limit postoperative complications. Few studies suggested less side effects in the paravertebral group. The vasoplegia due to the epidural can cause significant hypotension especially as reverse Trendelenburg position is required during surgery. The aim is to bring more light to the hemodynamic changes caused by two different locoregional techniques. An algorithm for fluid and vasopressor management has been proposed. We defined hypotension as 20% of decrement of the median arterial pressure during anesthesia. To reduce bias, the locoregional techniques is performed by an experienced anesthesiologists and the rest of the perioperative management is conducted by another blinded anesthesiologist. | Other | Epidural group, Paravertebral group |
Primary outcome
Consumption of norepinephrine and fluids during procedure
Time frame: 6 hours
norepinephrine mcg/kg/hr
1 secondary outcome
Postoperative complications
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Background: PubMed 30276441Low DE, Allum W, De Manzoni G, Ferri L, Immanuel A, Kuppusamy M, Law S, Lindblad M, Maynard N, Neal J, Pramesh CS, Scott M, Mark Smithers B, Addor V, Ljungqvist O. Guidelines for Perioperative Care in Esophagectomy: Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations. World J Surg. 2019 Feb;43(2):299-330. doi: 10.1007/s00268-018-4786-4.
- Background: PubMed 34795950Deana C, Vetrugno L, Bignami E, Bassi F. Peri-operative approach to esophagectomy: a narrative review from the anesthesiological standpoint. J Thorac Dis. 2021 Oct;13(10):6037-6051. doi: 10.21037/jtd-21-940.
- Background: PubMed 32087686Kingma BF, Eshuis WJ, de Groot EM, Feenstra ML, Ruurda JP, Gisbertz SS, Ten Hoope W, Marsman M, Hermanides J, Hollmann MW, Kalkman CJ, Luyer MDP, Nieuwenhuijzen GAP, Scholten HJ, Buise M, van Det MJ, Kouwenhoven EA, van der Meer F, Frederix GWJ, Cheong E, Al Naimi K, van Berge Henegouwen MI, van Hillegersberg R. Paravertebral catheter versus EPidural analgesia in Minimally invasive Esophageal resectioN: a randomized controlled multicenter trial (PEPMEN trial). BMC Cancer. 2020 Feb 22;20(1):142. doi: 10.1186/s12885-020-6585-1.
- Background: PubMed 31080659van den Berg JW, Tabrett K, Cheong E. Paravertebral catheter analgesia for minimally invasive Ivor Lewis oesophagectomy. J Thorac Dis. 2019 Apr;11(Suppl 5):S786-S793. doi: 10.21037/jtd.2019.03.47.
- Background: PubMed 26897642Yeung JH, Gates S, Naidu BV, Wilson MJ, Gao Smith F. Paravertebral block versus thoracic epidural for patients undergoing thoracotomy. Cochrane Database Syst Rev. 2016 Feb 21;2(2):CD009121. doi: 10.1002/14651858.CD009121.pub2.
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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.
Laszlo SZEGEDI, PHD study chair
Laszlo.szegedi@hubruxelles.be
Questions about this trial
What is this clinical trial studying?
A study testing Hemodynamic changes between epidural and paravertebral during esophagectomy in people with Esophagectomy and Epidural; Anesthesia, run by Erasme University Hospital.
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: opening soon, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annalinda CIORRA, MD (+32(0)25553324, annalinda.ciorra@hubruxelles.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consumption of norepinephrine and fluids during procedure (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06563557, which also lists 5 linked publications.
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 21 Aug 2024.