Indocyanine green fluorescence imaging in laparoscopic gastric cancer surgery: a safe and effective method to locate and remove tumors

Safety and efficacy of indocyanine green fluorescence imaging in laparoscopic distal gastrectomy for gastric cancer: a randomized clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17907053

Enrollment

410

Registered

2025-06-12

Start date

2019-09-07

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Improvement of tumor localization and reduction of positive resection margin in laparoscopic distal gastrectomy for gastric cancer Surgery

Interventions

Current interventions as of 15/09/2025: For patients who are assigned to the ICG group, endoscopic ICG injection was performed one day before surgery. ICG (Dandong Yichuang Pharmaceutical Co., Ltd)

Participants receive allocation information during the same visit 4. Quality Control Audit Trail: Complete timestamped randomization records maintained Balance Monitoring: Weekly checks of allocation

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years. 2. Pathologically proven gastric adenocarcinoma. 3. Clinical stage T1-4a, N0/+, M0 according to the 8th edition of American Joint Committee on Cancer (AJCC) TNM classification. 4. Scheduled for distal gastrectomy with D2 lymphadenectomy, and possible for R0 surgery by this procedure. 5. Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG). 6. American Society of Anesthesiology score (ASA) class I, II, or III. 7. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Allergic to iodine or specific contrast agents. 2. History of previous upper abdominal surgery. 3. History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection. 4. History of previous neoadjuvant chemotherapy or radiotherapy. 5. Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or disease. 6. Need for combined organ resection. 7. Need for concurrent surgeries due to other surgical diseases. 8. Direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations.

Design outcomes

Primary

Measure	Time frame
Positive rate of initial proximal margin is measured by intraoperative frozen section examination.	—

Secondary

Measure	Time frame
1. Incidence of intraoperative extended resection is measured using operative records at the time of surgery 2. Length of proximal margin is measured using a surgical ruler on the resected specimen immediately after resection 3. Morbidity rate is measured using Clavien-Dindo classification based on clinical records during the postoperative hospital stay and follow-up at 3 years 4. Mortality rate is measured using clinical records and death certificates during the postoperative period up to 3 years 5. 3-year overall survival rate is measured using patient follow-up data and survival status at 3 years post-surgery 6. 3-year disease-free survival rate is measured using follow-up imaging (CT or PET-CT), endoscopy, and tumor marker assessment at regular intervals up to 3 years post-surgery 7. 3-year recurrence pattern is measured using imaging (CT or PET-CT), endoscopy, and tumor marker assessment at regular intervals up to 3 years post-surgery 8. Number of dissected lymph nodes is measured using histopathological examination of surgical specimens immediately after surgery 9. Number of positive lymph nodes is measured using histopathological examination of surgical specimens immediately after surgery 10. Operation time is measured using operative records at the time of surgery 11. Intraoperative blood loss is measured using anesthetic and surgical records at the time of surgery 12. Postoperative recovery course is measured using clinical records including time to first flatus, time to oral intake, and length of hospital stay during the postoperative period 13. Positive rate of gastric tissue at 1cm from the tumor (GT1) is measured using histopathological examination of resected specimens immediately after surgery 14. Positive rate of gastric tissue at 2cm from the tumor (GT2) is measured using histopathological examination of resected specimens immediately after surgery 15. Positive rate of gastric tissue at 3cm from the tumor (GT3) is measured	—

Measure

Time frame

1. Incidence of intraoperative extended resection is measured using operative records at the time of surgery 2. Length of proximal margin is measured using a surgical ruler on the resected specimen immediately after resection 3. Morbidity rate is measured using Clavien-Dindo classification based on clinical records during the postoperative hospital stay and follow-up at 3 years 4. Mortality rate is measured using clinical records and death certificates during the postoperative period up to 3 years 5. 3-year overall survival rate is measured using patient follow-up data and survival status at 3 years post-surgery 6. 3-year disease-free survival rate is measured using follow-up imaging (CT or PET-CT), endoscopy, and tumor marker assessment at regular intervals up to 3 years post-surgery 7. 3-year recurrence pattern is measured using imaging (CT or PET-CT), endoscopy, and tumor marker assessment at regular intervals up to 3 years post-surgery 8. Number of dissected lymph nodes is measured using histopathological examination of surgical specimens immediately after surgery 9. Number of positive lymph nodes is measured using histopathological examination of surgical specimens immediately after surgery 10. Operation time is measured using operative records at the time of surgery 11. Intraoperative blood loss is measured using anesthetic and surgical records at the time of surgery 12. Postoperative recovery course is measured using clinical records including time to first flatus, time to oral intake, and length of hospital stay during the postoperative period 13. Positive rate of gastric tissue at 1cm from the tumor (GT1) is measured using histopathological examination of resected specimens immediately after surgery 14. Positive rate of gastric tissue at 2cm from the tumor (GT2) is measured using histopathological examination of resected specimens immediately after surgery 15. Positive rate of gastric tissue at 3cm from the tumor (GT3) is measured

—

Countries

China

Contacts

Public ContactYize Liang

liangyize1@163.com+86 17660440802

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 7, 2026