Tokyo, Dec. 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060117) titled 'PROspective randomized controlled pilot study of double-Tract jejunal reconstruction adding to subtotal stomach reconstruction for Esophageal Cancer Treatment' on Dec. 18.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - Gifu University
Condition:
Condition - esophageal cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - Short-term Postoperative Outcomes (DTGE Incidence Rate)
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Intervention group: Subtotal gastric reconstruction plus double-tract gastrojejunostomy (conventional method + jejunal double-tract method)
Interventions/Control_2 - Control group: Conventional subtotal gastric reconstruction (conventional method)
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - 1) Patients scheduled to undergo radical resection with esophagectomy via thoracic manipulation for esophageal cancer or esophagogastric junction cancer at our hospital
2) Patients eligible for one-stage reconstruction
3) Patients eligible for reconstruction using a subtotal gastric tube
4) Patients for whom written consent has been obtained from the patient or their representative
Key exclusion criteria - 1) Patients requiring reconstruction using the colon or small intestine
2) Unresectable cases with distant metastasis (Stage IVb) or cases with T4a tumor invasion depth before chemotherapy and a high risk of postoperative mediastinal recurrence
3) Patients planning for two-stage reconstruction
4) Patients undergoing retrosternal reconstruction
5) Patients with a history of curative (chemo)radiotherapy for esophageal or pharyngeal cancer
6) Patients deemed inappropriate for research by the attending physician
Target Size - 15
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 12 Month 31 Day
Date of IRB - 2025 Year 12 Month 31 Day
Anticipated trial start date - 2026 Year 01 Month 10 Day
Last follow-up date - 2030 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068756
Disclaimer: Curated by HT Syndication.