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A prospective randomized controlled clinical study of lymph node dissection in patients with intrahepatic mass-forming cholangiocarcinoma

A prospective randomized controlled clinical study of lymph node dissection in patients with intrahepatic mass-forming cholangiocarcinoma

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036103
Enrollment
Unknown
Registered
2020-08-21
Start date
2020-09-10
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

intrahepatic mass-forming cholangiocarcinoma

Interventions

NLND:Hepatectomy
LND:Hepatectomy combined with regional lymph node dissection

Sponsors

Eastern Hepatobiliary Surgery Hospital Second, Military Medical University, Shanghai, China
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Pathologically diagnosis intrahepatic cholangiocarcinoma; above grade 2; without hilar invasion; stageT1-T2 assessed by AJCC 8th; No invasion of portal vein and main hepatic artery and free of extrahepatic metastasis; 2) Newly diagnosed patients without jaundice; 3) 18-85 years old, both sexes; 4) R0 resection; 5) Preoperative enhanced upper abdominal CT/MRI or PET-CT showed retroperitoneal lymph node negative or intraoperative diagnostic of suspected positive lymph nodes showed negative; 6) Normal functions of heart, liver and kidney; normal results of peripheral blood examination and electrocardiogram; without unhealed wound; Peripheral blood: WBC >= 3.0x10^9/L, PLT >= 80x10^9/L, Hb >= 90g/L; Renal function: Cr <= 2.0 x UNL (upper limit of normal); Liver function: Child A/B; ECOG PS: 0-2. 7) Sign ICF; good compliance, able to cooperate with experimental observation.

Exclusion criteria

Exclusion criteria: 1) With a history of other malignant tumors; 2) Have received chemotherapy, radiotherapy, immunotherapy or other treatments; 3) Liver dysfunction (upper gastrointestinal bleeding, hepatic encephalopathy) or Child C; 4) Positive retroperitoneal lymph node; 5) R1 or R2 resection; 6) Severe atherosclerosis; 7) The investigator believes that the patient should not participate in this trial.

Design outcomes

Primary

MeasureTime frame
OS;

Secondary

MeasureTime frame
DFS;Safety;Proportion of regional lymph node metastasis;

Countries

China

Contacts

Public ContactYongjie Zhang

Eastern Hepatobiliary Surgery Hospital Second, Military Medical University

63834066@qq.com+86 13601627240

Outcome results

None listed

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