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Study on the effect of individualized positive end-expiratory pressure on lung and kidney protection during minimally invasive esophagectomy in the prone position (single-blind, randomized controlled trial)

Study on the effect of individualized positive end-expiratory pressure on lung and kidney protection during minimally invasive esophagectomy in the prone position (single-blind, randomized controlled trial) - Study on the effect of individualized positive end-expiratory pressure on lung and kidney protection during minimally invasive esophagectomy in the prone position (single-blind, randomized controlled trial)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000060233
Enrollment
60
Registered
2025-12-31
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal or gastroesophageal junction cancer

Interventions

To determine the optimal PEEP level, the individualized group increases the PEEP level by 2 cmH2O per minute from 0 to 16 cmH2O during one-lung ventilation without changing the tidal volume or ventila

Sponsors

Juntendo University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Subjects aged 20 to 80 years at the time of consent. 2. Subjects undergoing minimally invasive esophagectomy in the prone position using thoracoscopic or robotic assistance. 3. Subjects who agree to undergo combined epidural anesthesia. 4. Subjects who have received a thorough explanation of this study and fully understood the requirements, and who have provided their own voluntary written consent.

Exclusion criteria

Exclusion criteria: 1. Patients undergoing gastrointestinal reconstruction using intrathoracic anastomosis 2. Patients with severe obesity (body mass index 35 kg/m2 or greater) 3. Patients with severe chronic obstructive pulmonary disease (FEV1% < 50%) 4. Patients with interstitial pneumonia (including patients suspected of having interstitial pneumonia based on diagnostic imaging) 5. Patients with giant lung cysts (emphysematous lung cysts occupying one-third or more of one thoracic cavity) 6. Patients with a tracheostomy 7. Patients with pulmonary hypertension or intracranial hypertension, even if mild, who are considered to be unable to tolerate hypercapnia 8. Other subjects deemed inappropriate by the principal investigator

Design outcomes

Primary

MeasureTime frame
Serum interleukin-6 (IL-6) concentrations after chest manipulation

Countries

Japan

Contacts

Public ContactShihoko Iwata

Juntendo University Hospital Department of Anesthesiology and Pain Medicine

s.iwata.st@juntendo.ac.jp81-3-3813-3111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026