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Extended Lymphadenectomy for Bile Duct Cancer

N/A
Recruiting
Research Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Liver function Child-Turcotte-Pugh score A-B grade
No obvious lymph node metastasis in preoperative imaging; or negative intraoperative lymph node biopsy
Must not have
The patient has a history of other malignant tumors
Liver function Child-Turcotte-Pugh score C
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years after surgery
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying the standardization of lymph node dissection in ICC.

Who is the study for?
This trial is for adults aged 18-80 with intrahepatic cholangiocarcinoma (ICC), a type of bile duct cancer. Candidates must have resectable tumors without obvious lymph node metastasis, adequate liver function (Child-Turcotte-Pugh score A-B), and be able to tolerate surgery. They should understand the study and consent to follow-up plans. Those with severe organ dysfunction or other cancers are excluded.
What is being tested?
The trial investigates whether extending lymph node removal during ICC tumor resection improves patient outcomes compared to regional lymphadenectomy alone. It aims to clarify if more extensive surgery affects survival rates, given contradictory findings in previous studies.
What are the potential side effects?
Potential side effects may include complications from extended surgical procedures such as increased risk of infection, bleeding, longer recovery times, and possibly impacts on liver function due to the more invasive nature of extended lymphadenectomy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My liver is working well enough, not the worst.
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My scans or biopsy show no signs of cancer spread to lymph nodes.
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My liver cancer was confirmed and deemed removable by surgery.
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My liver can function properly even after a major surgery.
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I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had other types of cancer in the past.
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My liver is severely impaired.
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I have heart, lung, brain, or kidney issues that could interfere with my cancer treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Disease free survival (DFS)
Secondary study objectives
3-year Overall survival (OS)
5-year Overall survival (OS)
Rate of Postoperative Complications (PC)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Extend LymphAdenectomyExperimental Treatment1 Intervention
Expanded lymph node dissection for right liver tumors included stations 12, 8, and 13, and stations 12, 1, 3, 7, and 8 for left liver tumors
Group II: Regional LymphAdenectomyActive Control1 Intervention
Regional lymph node dissection for intrahepatic cholangiocarcinoma included station 12.

Find a Location

Who is running the clinical trial?

Second Affiliated Hospital, School of Medicine, Zhejiang UniversityLead Sponsor
932 Previous Clinical Trials
1,924,017 Total Patients Enrolled
2 Trials studying Liver Cancer
1,658 Patients Enrolled for Liver Cancer

Media Library

Extend LymphAdenectomy Clinical Trial Eligibility Overview. Trial Name: NCT04078230 — N/A
Liver Cancer Research Study Groups: Extend LymphAdenectomy, Regional LymphAdenectomy
Liver Cancer Clinical Trial 2023: Extend LymphAdenectomy Highlights & Side Effects. Trial Name: NCT04078230 — N/A
Extend LymphAdenectomy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04078230 — N/A
~64 spots leftby Dec 2027
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