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Effect of enhanced preoperative enteral nutrition during neoadjuvant immunochemotherapy on perioperative efficacy of patients with esophageal cancer

Effect of enhanced preoperative enteral nutrition during neoadjuvant immunochemotherapy on perioperative efficacy of patients with esophageal cancer

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091292
Enrollment
Unknown
Registered
2024-10-24
Start date
2024-11-01
Completion date
Unknown
Last updated
2024-10-28

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

Conditions

esophageal carcinoma

Interventions

experimental group:With reference to the standard of energy required by the patients body 25-30kcal/kg and protein 1.5-2.0g/kg per day, the ONS requirement was calculated according to the actual intak
control group:The control group was given optimal nutritional support according to the guidelines for rapid rehabilitation of esophageal cancer. Nutritional assessment and dietary investigation were n

Sponsors

Department of Thoracic Surgery, First Affiliated Hospital of Xi’an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 75 Years

Inclusion criteria

Inclusion criteria: ? Age =75 years old, gender is not limited; ? Patients with esophageal cancer confirmed by cytology or histology and planned for surgical treatment; ? Preoperative ultrasound gastroscopy /CT confirmed that the tumor stage was cT2N0M0 with high-risk lesions (lymphovascular invasion, =3cm, poorly differentiated)/cT1b-2N+M0/cT3-4aN0-3M0, requiring neoadjuvant therapy before radical esophagectomy; ? Can eat orally (at least liquid diet) ?ECOG status score (PS)=2; Pre-recruitment body mass index (BMI)=18.5 kg/m2; The tumor did not invade the surrounding vital organs and distant metastasis; There was no obvious enlargement of supraclavicular and retroperitoneal lymph nodes and no evidence of distant metastasis (M0). ? The main organ function is basically normal: the lung function can accept general anesthesia; NYHA grades of cardiac function were 0 ~ 1. (9) Before the study, the patient and/or his legal representative have the ability to fully understand the content, process and possible adverse reactions of the study, and can make the patient comply with the visit required by the protocol; ? Women of childbearing age must have a negative pregnancy test and not be breastfeeding, confirm that both men and women are receiving a method of contraception approved by the investigator, and agree to maintain this contraceptive method from the signing of the informed consent until 3 months after the end of the study

Exclusion criteria

Exclusion criteria: ? Patients with other malignant tumors; ? Patients with a history of esophagectomy or gastrectomy; ? Patients with a history of thoracic surgery or extensive abdominal adhesion; (4) Patients with heart thrombosis; (5) Suffering from mental, psychiatric or neurological diseases; (6) Patients with cachexia and severe malnutrition are expected to survive less than 6 months; Recent recurrence of gastric ulcer, history of gastric bleeding and other serious underlying diseases; Patients with contraindications such as coagulopathy, HIV-positive antibody, and serious infection with poor clinical control; ? Patients with other co-existing diseases (such as obvious abnormalities of liver and kidney function, etc.) or co-medication, which the investigator judged may affect the results of this study. ? Patients who are also participating in another clinical study; (11) Patients who are known to be allergic to the material of surgical instruments, or to allergies; (12) Other participants judged by the investigator to be unfit to participate in the clinical trial;

Design outcomes

Primary

MeasureTime frame
Perioperative nutritional indexes; Perioperative complication rate;quality of life;

Secondary

MeasureTime frame
Neoadjuvant immunochemotherapy index;Survival and recurrence;

Countries

China

Contacts

Public ContactZhuoqi Jia

Department of Thoracic Surgery, First Affiliated Hospital of Xi’an Jiaotong University

gosnow@163.com+86 29 8532 3920

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026