Tokyo, Nov. 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059630) titled 'A Randomized Controlled Trial Evaluating the Utility of Preserving the Posterior Pulmonary Nerve Plexus During Mediastinal Lymph Node Dissection for Esophageal Cancer' on Nov. 4.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Kansai Medical University
Condition:
Condition - esophageal cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To investigate whether preservation of the posterior pulmonary plexus of automatic nerve during thoracoscopic and robot-assisted subtotal esophagectomy for thoracic esophageal cancer reduces postoperative respiratory complications such as chronic cough and pneumonia.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Preserve the Posterior Pulmonary Plexus of autonomic nerve
Preserving group
Interventions/Control_2 - Not preserving the Posterior Pulmonary Plexus of autonomic nerve
None preserving group
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients who are planned to undergo esophagectomy with middle to lower esophageal cancer with clinical stage I-IVA
Patients are older than 18 years old
Performance status (PS) is 0 to 2 according to ECOG criteria
Patients who consented with own free will to this study after receiving sufficient explanation and with adequate understanding
Key exclusion criteria - cases which tumor invaded to posterior pulmonary nerve plexus of autonomic nerve
Cases that are currently cancer-bearing other than esophageal cancer
Cases with severe respiratory disorders such as pulmonary emphysema, interstitial pneumonia, or bronchial asthma
Cases with severe liver dysfunction, cirrhosis, or active hepatitis
Cases with severe renal dysfunction
Cases with poorly controlled diabetes
Pregnant women or those who may be pregnant, women who are breastfeeding
Cases diagnosed inappropriate to conduct this research safely by principal investigator
Target Size - 60
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 17 Day
Anticipated trial start date - 2026 Year 01 Month 01 Day
Last follow-up date - 2026 Year 01 Month 01 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068002
Disclaimer: Curated by HT Syndication.
