Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061062) titled 'Contribution of RGA preserving PPPD for reducing complication rate of duodenojejunostomy compared to RGA transecting PPPD: A randomized controlled trial' on April 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Iwate Medical University
Condition:
Condition - Patients with HPB/duodenal diseases requiring PPPD
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To clarify the significance of RGA preserving PPPD for reducing complication rate of duodenojejunostomy
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Preservation of RGA
Interventions/Control_2 - Transection of RGA
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - 1 Patients requiring PPPD due to HPB/duodenal diseases
2 Age over 18 years old
3 Obtaining written informed consent
Key exclusion criteria - 1 Prior chemotherapy and/or radiotherapy, conversion case
2 Bulky LN metastasis at baseline
3 Requiring vessel reconstruction
4 Any patinets judged as insuitable for enrollment
Target Size - 140
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2026 Year 02 Month 01 Day
Date of IRB - 2026 Year 02 Month 01 Day
Anticipated trial start date - 2026 Year 02 Month 01 Day
Last follow-up date - 2026 Year 02 Month 01 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069786
Disclaimer: Curated by HT Syndication.
