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A prospective, multi-center, randomized controlled study on the effectiveness and safety of regional lymph node dissection in radical resection of intrahepatic cholangiocarcinoma

A prospective, multi-center, randomized controlled study on the effectiveness and safety of regional lymph node dissection in radical resection of intrahepatic cholangiocarcinoma

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039575
Enrollment
Unknown
Registered
2020-11-01
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-02-08

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

Conditions

intrahepatic cholangiocarcinoma

Interventions

Intervention Group:Regional lymph node dissection
Control Group:None

Sponsors

The First Affiliated Hospital, Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients between 18 and 80 years of age; 2. Preoperative imaging and laboratory examinations are diagnosed as intrahepatic cholangiocarcinoma, and postoperative pathology is diagnosed as intrahepatic cholangiocarcinoma; 3. Patients with intrahepatic cholangiocarcinoma whose preoperative imaging evaluation is resectable and postoperative pathology confirmed R0 resection; 4. No lymph node metastasis other than regional lymph nodes is found in preoperative imaging and intraoperative evaluation; 5. Child-Pugh score is A or B; 6. The volume of residual liver is more than 30%; 7. ASA classification is 1-4 level; 8. Patients have autonomy, can understand and voluntarily sign written informed consent and can complete the follow-up plan; 9. Female patients of gestational age should be excluded from pregnancy; 10. The written informed consent should be signed before the screening stage of trial.

Exclusion criteria

Exclusion criteria: 1. The patient has obvious heart, lung, brain, or kidney insufficiency, who cannot tolerate surgery; 2. The patient has or is currently combined with other malignant tumors; 3. Female patients who are pregnant or breastfeeding; 4. The investigator judges that it is not suitable to participate in this research.

Design outcomes

Primary

MeasureTime frame
Postoperative 5-year overall survival;

Secondary

MeasureTime frame
Postoperative 3- and 5-year recurrence-free survival;Postoperative 3-year overall survival;Postoperative complications and 30-day mortality;Postoperative chemotherapy effect;

Countries

China

Contacts

Public ContactXiao-Yu Yin

The First Affiliated Hospital, Sun Yat-Sen University

yinxy@mail.sysu.edu.cn+86 18902233509

Outcome results

None listed

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