Clinical Trial: Examination of clinical utility of a novel formula containing fermented milk for early enteral nutrition after surgery for malignant esophageal tumors (Japan)

Tokyo, Oct. 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059435) titled 'Examination of clinical utility of a novel formula containing fermented milk for early enteral nutrition after surgery for malignant esophageal tumors' on Oct. 16.

Study Type: Observational

Primary Sponsor: Institute - National Cancer Center Hospital

Condition: Condition - Esophageal cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To prospectively observe the effects of early enteral nutrition using a fomula containing fermented milk on abdominal symptom, infectious complications, and gut/oral microbiota in patients after surgery for malignant esophageal tumors Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - 1. Patients aged between 20 and 89 years old at the time of obtaining consent or day of surgery 2. Patients diagnosed with malignant tumor arising in the esophagus or esophagogastric junction, regardless of histological type 3. Patients who underwent subtotal esophagectomy based on the diagnosis in 2), regardless of preoperative treatment 4. Patients who received thoracoscopic and laparoscopic esophagectomy (including robot-assisted surgery), and who underwent one-stage gastric conduit reconstruction. Patients will be excluded if they meet any of the following apply (i) Patients who underwent two-stage surgery. (ii) Patients who underwent gastrointestinal reconstruction using grafts other than gastric conduit (such as colonic of jejunal reconstruction). (iii) Patients who were converted to thoractomy or laparotomy during surgery. (iv) Patients whose surgery was cancelled for any reason. (v) Patients who underwent jejunostomy. Key exclusion criteria - 1. Patients with a history of abdominal surgery accompanied with excision of gastrointestinal tract. 2. Patients with a past histroy of inflammatory bowel disease. 3. Patients whose HbA1c value was above 7.0% at the most recent outpatient visit before surgery. 4. Patients who received antibiotic treatment within one month before surgery. 5. Patients who underwent enteral nutrition of central veous nutrition within one month berfore surgery. 6. Patients who developed infectious enteritis after surgery. 7. Patients who underwent reoperation. 8. Patients who could not start enteral nutrition for any reason. 9. Patients who were deemed inappropriate by the principal investigator or co-investigator. Target Size - 200

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 09 Month 08 Day Date of IRB - 2025 Year 09 Month 08 Day Anticipated trial start date - 2025 Year 10 Month 16 Day Last follow-up date - 2028 Year 04 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067960

Disclaimer: Curated by HT Syndication.