Routine Lymphadenectomy for Intrahepatic Cholangiocarcinoma

NCT03796819 | Completed DMC

• 1 other identifier: XJTU1AFCRC2017SJ-007
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

The role of routine lymphadenectomy (LND) in the surgical treatment of intrahepatic cholangiocarcinoma (ICC) remains controversial. The investigators' multi-institutional retrospective study have showed an increasing adoption of LND among patients undergoing curative resection for ICC during the last decade. The current prospective and randomized study based on a multi-institutional collaboration would investigate whether routine LND would benefit patients in short- and long-term survival remains.

Conditions

Intrahepatic Cholangiocarcinoma

Keywords

intrahepatic cholangiocarcinoma; surgery; lymphadenectomy; lymph node metastasis; prognosis

Outcome Measures

Primary Outcomes (2)

• 1-year recurrence rate

  compare the 1-year recurrence rate of patients undergoing lymphadenectomy and those not undergoing lymphadenectomy

  1 year after surgery (up to 1 year)

• 3-year recurrence rate

  compare the 3-year recurrence rate of patients undergoing lymphadenectomy and those not undergoing lymphadenectomy

  3 years after surgery (up to 3 years)

Secondary Outcomes (3)

• Postoperative morbidity

  From the date of surgery to stitches off (up to 1 month)

• 1-year overall survival

  1 year after surgery (up to 1 year)

• 3-year overall survival

  3 years after surgery (up to 3 years)

Study Arms (2)

lymphadenectomy

EXPERIMENTAL

This group of patients would undergo routine hepatoduodenal lymphadenectomy combined with ICC resection

Procedure: lymphadenectomy

No lymphadenectomy

NO INTERVENTION

This group of patients would not undergo hepatoduodenal lymphadenectomy when preoperative imaging and intraoperative exploration found no lymph node enlargement.

Interventions

lymphadenectomy PROCEDURE

Patients would undergo routine hepatoduodenal lymphadenectomy at the time of ICC resection

lymphadenectomy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with intrahepatic cholangiocarcinoma by imaging or biopsy
• The tumor is limited in the liver with no distant metastasis, and the primary disease is resectable
• Preoperative imaging (e.g. CT, MRI, PET-CT, etc.) and intraoperative exploration found no nodal swelling or enlargement

You may not qualify if:

• The primary disease is unresectable with or without distant metastasis
• The liver function or general condition of patients does not permit surgery
• Preoperative imaging (e.g. CT, MRI, PET-CT, etc.) and intraoperative exploration found obvious nodal swelling or enlargement, which indicates lymphadenectomy should be performed
• Patients aged below 18 or older than 65 would be excluded
• Pregnant women would not be enrolled

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• Ningxia Medical University: collaborator
• Nanchang University: collaborator
• Binzhou Medical University: collaborator
• Shaanxi Provincial People's Hospital: collaborator
• Shaanxi University of Chinese Medicine: collaborator
• The Third Affiliated Hospital of Beijing University: collaborator

Study Sites (1)

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

MeSH Terms

Conditions

Cholangiocarcinoma; Lymphatic Metastasis

Interventions

Lymph Node Excision

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Yi Lv, MD, PhD

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY CHAIR

• Xu-Feng Zhang, MD,PhD

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: patients would not be told about the lymphadenectomy
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: routine hepatoduodenal lymphadenectomy

Study Record Dates

• First Submitted: January 6, 2019
• First Posted: January 8, 2019
• Study Start: January 10, 2019
• Primary Completion: August 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 9, 2021

Record last verified: 2019-08

Locations

CN (1)