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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years after surgery
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years after surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease free survival (DFS)
Secondary outcome measures
3-year Overall survival (OS)
5-year Overall survival (OS)
Rate of Postoperative Complications (PC)
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.
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Who is running the clinical trial?
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityLead Sponsor
820 Previous Clinical Trials
1,782,157 Total Patients Enrolled
1 Trials studying Intrahepatic Cholangiocarcinoma
9 Patients Enrolled for Intrahepatic Cholangiocarcinoma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I understand the study, agree to participate, and can follow the study plan.My liver is working well enough, not the worst.I have had other types of cancer in the past.My scans or biopsy show no signs of cancer spread to lymph nodes.My liver is severely impaired.My liver cancer was confirmed and deemed removable by surgery.My liver can function properly even after a major surgery.I am between 18 and 80 years old.I have heart, lung, brain, or kidney issues that could interfere with my cancer treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Extend LymphAdenectomy
- Group 2: Regional LymphAdenectomy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I qualified to partake in this research?
"This clinical trial is recruiting 168 individuals with cholangiocarcinoma of varying ages, from 18 to 80. To qualify for the study, patients must have a Child-Turcotte-Pugh score between A and B grade; more than 30% residual liver volume; no visible lymph node metastasis in preoperative imaging or negative intraoperative biopsy results; and be able to tolerate radical hepatectomy."
Answered by AI
How many participants are participating in this experimental research?
"Affirmative, according to clinicaltrials.gov's records it appears that this research is actively recruiting patients. It was initially posted on January 1st 2020 and the most recent update took place November 7th 2022; a total of 168 individuals are needed from one site."
Answered by AI
Does this clinical research accommodate adults of twenty years and older?
"This trial has an upper age limit of 80 years old, and participants must be over 18 to qualify."
Answered by AI
Is this clinical study presently open to recruitment of participants?
"According to the clinicaltrials.gov database, this investigation is still seeking participants. This trial was initially posted on January 1st 2020 and most recently revised on November 7th 2022."
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