Skip to content

Safety and efficacy of indocyanine green fluorescent tracer for intraoperative sentinel lymph node biopsy of biliary tract tumors

Safety and efficacy of indocyanine green fluorescent tracer for intraoperative sentinel lymph node biopsy of biliary tract tumors

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100050196
Enrollment
Unknown
Registered
2021-08-22
Start date
2021-09-01
Completion date
Unknown
Last updated
2022-04-25

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

Conditions

intrahepatic cholangiocarcinoma

Interventions

Sponsors

Cancer Hospital of Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 70 Years

Inclusion criteria

Inclusion criteria: 1. Preoperative clinical/pathological diagnosis was primary intrahepatic cholangiocarcinoma; 2. Age <=70 years old, without serious circulatory, respiratory or metabolic complications; 3. It was confirmed by preoperative imaging examination and intraoperative exploration as a single lesion without intrahepatic/extrahepatic metastasis; 4. Intraoperative evaluation of the tumor can be R0 resection.

Exclusion criteria

Exclusion criteria: 1. Complicated with malignant tumors of other organs or systems; 2. Other major organ excision was performed simultaneously during the operation; 3. Postoperative pathology confirmed non-ICC; 4. Other conditions that the investigator considers unsuitable for patients to participate in this study.

Design outcomes

Primary

MeasureTime frame
Location and number of lymph nodes in ICG fluorescence development;Sentinel lymph node detection rate (number of lymph nodes detected at ICG tracer sites/number of ICG tracer sites);Positive sentinel lymph node detection rate (number of SLN positive cases/number of pathologically confirmed LNM cases);False negative rate of sentinel lymph nodes (number of SLN negative cases/number of pathologically confirmed LNM cases);Sensitivity;Specificity;Positive predictive value;Negative predictive value;

Secondary

MeasureTime frame
Intraoperative blood loss (total blood loss, lymph node resection related blood loss, liver resection blood loss);Operation time (total time, ICG tracer lymph node resection time, total lymph node resection time, liver resection time);Postoperative liver function;Incidence of lymphatic fistula;Degree of lymphatic fistula;Time to relapse free survival;Recurrence pattern;Overall survival;

Countries

China

Contacts

Public ContactWang Hongguang

Cancer Hospital of Chinese Academy of Medical Sciences

stewen_wang@sina.com+86 13717659265

Outcome results

None listed

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