Tokyo, Oct. 24 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059507) titled 'Impact of a Specialized Multidisciplinary Intervention on Outcomes in Elderly Patients Undergoing Pancreaticoduodenectomy' on Oct. 24.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - St. Marianna University School of Medicine

Condition: Condition - Diseases Indicated for Pancreaticoduodenectomy Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - Although the attending physicians had previously provided explanations regarding the importance of nutrition and exercise, direct preoperative interventions by dietitians and physical therapists had not been implemented. Therefore, this study aims to examine whether direct preoperative interventions by specialized multidisciplinary professionals in nutritional management and prehabilitation improve surgical outcomes in elderly patients undergoing pancreaticoduodenectomy (PD). We hypothesize that identifying the significance of active, direct multidisciplinary involvement from the preoperative phase will contribute to improving the safety of PD in high-risk elderly patients.

If the results of this study demonstrate better outcomes in the group receiving active, direct multidisciplinary interventions before surgery, it will confirm the clinical value of specialized multidisciplinary involvement. Conversely, if no significant difference is observed between the intervention and non-intervention groups, it will suggest that frequent preoperative counseling by dietitians and physical therapists may not be necessary and could represent an inefficient use of medical resources. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Once the diagnosis is established and surgery is scheduled, patients in Group A will receive direct preoperative interventions from specialized professionals-dietitians and physical therapists-using our institution's original educational booklet, "Exercise, Nutrition, and Diabetes Handbook for Biliary and Pancreatic Diseases". For nutritional therapy, dietitians will provide individualized dietary counseling with a target protein intake of 1.5 g per ideal body weight (IBW) per day. If dietary intake alone is insufficient to meet this target, patients will be instructed to supplement with one 250 mL bottle of an enteral nutritional formula (ENEVO, 0.83 yen/mL) daily. For exercise therapy, physical therapists will instruct patients to perform the following exercises: (1) toe raises, (2) knee bends, (3) abdominal curl-ups ("looking at the navel"), and (4) forward lunges-15 repetitions per set, twice daily, in addition to walking 8,000 steps per day. In Group A, compliance with nutritional and exercise interventions will be reviewed weekly through face-to-face interviews, and additional counseling will be provided as necessary. These interventions will be implemented from the time the surgical indication is confirmed until immediately before surgery. Interventions/Control_2 - In Group B, the handbook will not be used; instead, patients will receive only conventional nutritional and exercise guidance provided by their attending surgeons.

Eligibility: Age-lower limit - 70 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1) Patients scheduled to undergo pancreaticoduodenectomy in the Department of Gastrointestinal and General Surgery, St. Marianna University Hospital.

2) Patients aged 70 years or older at the time of obtaining informed consent.

3) Patients who are able to walk without assistive devices.

4) Patients who have received a full explanation of the study, fully understood the content, and voluntarily provided written informed consent to participate. Key exclusion criteria - 1) Patients for whom preoperative nutritional and exercise therapy is difficult (including patients with a preoperative waiting period of less than 3 weeks) 2) Patients undergoing resection involving multiple organs 3) Patients with metallic implants or tattoos in the body 4) Patients with concomitant psychiatric disorders 5) Patients for whom informed consent cannot be obtained 6) Other patients deemed unsuitable as subjects by the principal (or sub-investigator) Target Size - 140

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 08 Month 27 Day Anticipated trial start date - 2025 Year 10 Month 25 Day Last follow-up date - 2029 Year 12 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068069

Disclaimer: Curated by HT Syndication.