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An Exploratory Clinical Trial on the Safety of Enteral Nutrition for Postoperative Esophageal Cancer Patients

An exploratory clinical study to evaluate the safety and short-term nutritional outcomes of postoperative enteral nutrition with a digestive-form nutrient in patients with esophageal cancer undergoing minimally invasive esophagectomy.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs051230110
Enrollment
32
Registered
2023-10-10
Start date
2024-01-15
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal cancer minimally invasive esophagectomy, enteral feeding

Interventions

In this study, enteral nutrition intervention will be performed in patients who have undergone minimally invasive esophagectomy, and enteral feeding tube placement.
minimally invasive esophagectomy, enteral feeding

Sponsors

Goto Hironobu
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Age 18 years or older at the time of consent (2) Diagnosed as cStage I/II/III (12th edition of the Esophageal Cancer Treatment Protocol) and underwent subtotal esophagectomy, primary reconstruction, enteral tube placement (3) ECOG-PS 0-2 (4) Able to take oral intake before surgery (5) Expected to undergo surgery within 60 days of study enrollment (within 60 days of completion of chemotherapy for patients undergoing preoperative chemotherapy) (6) Patients are expected to be able to take oral intake for 3 months after surgery (7) The patient's free written consent to participate in the study has been obtained.

Exclusion criteria

Exclusion criteria: (1) The subject is allergic to oral nutritional supplements. (2)Identified as allergic to any of the ingredients (especially soy and gelatin) in the test nutritional product, Hinex E-Gel LC. (3) The subject has difficulty obtaining consent due to dementia or mental illness requiring treatment. (4) The patient is taking steroids or immunosuppressive drugs due to an autoimmune disease, etc. (5) Complicated viral infection requiring treatment. (6) Other conditions deemed inappropriate by the Principal Investigator or Principal Investigators.

Design outcomes

Primary

MeasureTime frame
Evaluate adherence to dosing at 2 months after esophagectomy.

Secondary

MeasureTime frame
Duration of Hinex-Egel administration ECOG-PS (2 months, 3 months, 6 months after surgery) Nutritional index items by blood biochemical tests (preoperative, 2 months, 3 months, and 6 months postoperatively) Body weight loss rate at 2, 3, and 6 months after esophagectomy Fat mass and skeletal muscle mass using CT images (preoperatively and 6 months postoperatively) Occurrence of disease, etc. (gastrointestinal symptoms related to protocol treatment: diarrhea, constipation, vomiting, etc.)

Contacts

Public ContactHironobu Goto

Kobe University Hospital

hirogoto@med.kobe-u.ac.jp+81-78-382-5925

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026