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The application of nerve monitoring to protect the vagus nerve in indocyanine green labeled radical gastrectomy for gastric cancer: a prospective, randomized controlled trial

The application of nerve monitoring to protect the vagus nerve in indocyanine green labeled radical gastrectomy for gastric cancer: a prospective, randomized controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059489
Enrollment
Unknown
Registered
2022-05-02
Start date
2022-05-01
Completion date
Unknown
Last updated
2024-03-11

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

Conditions

Gastric Cancer

Interventions

Group 1 :Neuroprotection + Indocyanine Green
Group 2:No neuroprotection + indocyanine green

Sponsors

Qilu Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. First-time gastric cancer patients aged 18-80 years; 2. The preoperative tumor clinical stage is T1-2N0M0 according to AJCC-8thTNM; 3. The tumor is expected to undergo radical distal gastrectomy, and D1/D1+ lymph node dissection is R0; 4. Able to tolerate general anesthesia.

Exclusion criteria

Exclusion criteria: 1. Recurrent gastric cancer; 2. Age 80 years; 3. There was obvious abdominal lymph node metastasis before operation; 4. Combined with serious complications with poor control, such as diabetes and rheumatism; 5. Gastric cancer patients who have implemented neoadjuvant therapy or recommended neoadjuvant therapy; 6. Gastric cancer complications (bleeding, perforation, obstruction) and need emergency surgery; 7. Patients with mental illness and those who have no insight and can't express it accurately; 8. Simultaneous surgery for other diseases, such as cholecystectomy, is needed.

Design outcomes

Primary

MeasureTime frame
The incidence of gastric paralysis;

Secondary

MeasureTime frame
Gallbladder Contractile Function;Incidence of gallstone;Incidence of cholecystitis;Incidence of abdominal fullness;Incidence of diarrhea;Incidence of constipation;Disease free survival;Tumor recurrence rate;Quality of life;

Countries

China

Contacts

Public ContactWenbin Yu

Qilu Hospital of Shandong University

wenbin_yu2003@163.com+86 18560085155

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026