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A prospective, randomized, open label clinical study of indocyanine green fluorescence tracing to judge the efficacy of different shapes of tubular stomach in preventing anastomotic leakage

A prospective, randomized, open label clinical study of indocyanine green fluorescence tracing to judge the efficacy of different shapes of tubular stomach in preventing anastomotic leakage

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065286
Enrollment
Unknown
Registered
2022-11-01
Start date
2022-11-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Esophageal Cancer

Interventions

thin tube group:The cutting edge was 3-5 cm away from the greater curvature of the stomach, and the tissue on the lateral side of the lesser curvature was removed using a linear cutting closure parall
flexible tube:Starting approximately 5 cm from the proximal end of the pyloric ring, a tubular stomach of approximately 4 cm in width was created with a linear cutting closure in the area supplied by

Sponsors

Fujian Medical University Union Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. 18 years < age < 75 years. 2. Esophageal primary lesion diagnosed as esophageal cancer by endoscopic biopsy histopathology. 3. Preoperative clinical stage of cT1-3, N0-1, M0, according to AJCC-8th TNM tumor stage. 4. No distant metastasis was seen in the preoperative examination, and the tumor did not directly invade the adjacent organs. 5. Pre-operative ECOG physical status score 0/1. 6. Preoperative ASA score I-III. 7. Patient informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant or breastfeeding women. 2. Suffering from severe mental illness. 3. history of other malignant diseases within 5 years. 4. history of unstable angina pectoris or myocardial infarction within 6 months. 5. history of cerebral infarction or cerebral hemorrhage within 6 months. 6. A history of continuous systemic corticosteroid therapy within 1 month. 7. Contemporaneous surgical treatment for other diseases to be performed. 8. A previous history of allergy to indocyanine green drug. 9. Patients who were unable to cooperate with this study due to psychological, family or social reasons and refused to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
anastomotic leakage;Anastomotic mediastinal/intrathoracic fistula;

Secondary

MeasureTime frame
Incidence of surgical complications;Surgical mortality;Disease Free Survival;Overall Survival;

Countries

China

Contacts

Public ContactJiangbo Lin

Fujian Medical University Union Hospital

135279779@qq.com+86 13365910827

Outcome results

None listed

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