Extended Lymphadenectomy for Bile Duct Cancer

Recruiting in Palo Alto (17 mi)

+12 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Disqualifiers: Heart, lung, brain, kidney dysfunction, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

Intrahepatic cholangiocarcinoma (ICC) is one of the common malignant tumors. Lymph node metastasis is an important factor affecting the poor prognosis of intrahepatic cholangiocarcinoma. The eighth edition of the AJCC guidelines recommends at least 6 lymph nodes to be used for staging. The American Hepatobiliary and Pancreatic Association also recommends the removal of hilar lymph nodes as part of the radical surgery for intrahepatic cholangiocarcinoma. However, some scholars have found that patients with regional lymph nodes have similar survival rates. This contradictory result has prompted more scholars to conduct clinical research to explore the necessity and standardization of lymph node dissection in intrahepatic cholangiocarcinoma.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that Extended Lymphadenectomy for Bile Duct Cancer is an effective treatment?

The available research shows that Extended Lymphadenectomy can help achieve long-term survival in patients with extrahepatic bile duct cancer when combined with other surgical procedures. It is particularly effective for patients without cancer spread to the lymph nodes and when the surgery successfully removes all cancerous tissue. This treatment also helps in accurately determining the stage of the cancer, which is crucial for planning further treatment. However, the benefits are more pronounced in selected patients, and the overall impact on long-term survival varies.

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What safety data exists for extended lymphadenectomy in bile duct cancer?

The provided research focuses on neck dissection in head and neck cancers, not bile duct cancer. However, it highlights that extensive lymph node surgery can lead to complications such as lymphedema, nerve damage, and sensory issues. These findings suggest that similar risks might be considered for extended lymphadenectomy in bile duct cancer, but specific safety data for this treatment in bile duct cancer is not provided in the research.

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Is the treatment Extended Lymphadenectomy a promising treatment for bile duct cancer?

Extended Lymphadenectomy, which involves removing more lymph nodes during surgery, is being studied to see if it helps people with bile duct cancer. Some research suggests it might be beneficial, especially for certain types of bile duct cancer, but more studies are needed to fully understand its advantages.

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Eligibility Criteria

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.

Inclusion Criteria

Sign the written informed consent form prior to the test screening

I understand the study, agree to participate, and can follow the study plan.

My liver is working well enough, not the worst.

Exclusion Criteria

I have had other types of cancer in the past.

My liver is severely impaired.

The investigator determined that it was not suitable for the study.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo either regional or extended lymphadenectomy during resection of intrahepatic cholangiocarcinoma

1 day

1 visit (in-person)

Postoperative Recovery

Participants are monitored for postoperative complications and recovery

up to 2 months

Multiple visits (in-person)

Follow-up

Participants are monitored for disease-free survival and overall survival

5 years

Participant Groups

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.

Group I: Extend LymphAdenectomy Experimental Treatment 1 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 LymphAdenectomy Active Control 1 Intervention

Regional lymph node dissection for intrahepatic cholangiocarcinoma included station 12.

Extend LymphAdenectomy is already approved in United States, European Union, China for the following indications:

🇺🇸 Approved in United States as Extended Lymphadenectomy for:

• Intrahepatic cholangiocarcinoma staging and treatment

🇪🇺 Approved in European Union as Extended Lymphadenectomy for:

• Intrahepatic cholangiocarcinoma staging and treatment

🇨🇳 Approved in China as Extended Lymphadenectomy for:

• Intrahepatic cholangiocarcinoma staging and treatment

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

The Johns Hopkins Hospital Baltimore, MD

Who Is Running the Clinical Trial?

Second Affiliated Hospital, School of Medicine, Zhejiang University Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Prognostic factors after pancreatoduodenectomy with extended lymphadenectomy for distal bile duct cancer. [2022] Since 1995, we have been performing pancreatoduodenectomy with regional and para-aortic lymph node dissection for patients with distal bile duct cancer. Prognostic indicators after extended lymphadenectomy have not been fully understood.

2. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical prognostic significance of regional and extended lymphadenectomy for biliary cancer with para-aortic lymph node metastasis: A systematic review and meta-analysis. [2022] The aim of our study was to evaluate clinical prognostic significance of regional and extended lymphadenectomy for biliary cancer with para-aortic lymph node metastasis.

3. United States pubmed.ncbi.nlm.nih.gov

Rational Extent of Regional Lymphadenectomy and the Prognostic Impact of the Number of Positive Lymph Nodes for Perihilar Cholangiocarcinoma. [2023] The definition and classification of regional nodes are not standardized for perihilar cholangiocarcinoma. This study aimed to clarify the rational extent of regional lymphadenectomy and to elucidate the impact of number-based regional nodal classification on survival of patients with this disease.

4. United States pubmed.ncbi.nlm.nih.gov

Radical resection of biliary tract cancers and the role of extended lymphadenectomy. [2009] Extended hemihepatectomy and/or pancreatoduodenectomy plus extrahepatic bile duct resection and an extended lymphadenectomy of up to the group 2 lymph nodes can enable long-term survival in patients with extrahepatic bile duct (EBD) cancer with acceptable surgical risks. Surgeons should dissect and examine at least 10 or more nodes in curative intent surgeries for local disease control and accurate staging. Radical surgical procedures for EBD cancer, including a right lobectomy, left trisectoriectomy, hepatopancreatoduodenectomy, and combined vascular resection and reconstruction, are useful options for obtaining a negative margin, but the benefits of such procedures to long-term survival rates is limited to selected patients without nodal metastasis and with negative surgical margins.

5. United States pubmed.ncbi.nlm.nih.gov

Prognostic value of lymphadenectomy for long-term outcomes in node-negative intrahepatic cholangiocarcinoma: A multicenter study. [2020] Lymphadenectomy ensures accurate staging for patients with intrahepatic cholangiocarcinoma, especially for those without preoperatively suspected positive lymph nodes (clinically node-negative); however, its prognostic value has been poorly documented. The aim of this study was to evaluate the prognostic value of lymphadenectomy on long-term outcomes in patients undergoing surgery for clinically node-negative intrahepatic cholangiocarcinoma.

6. Ireland pubmed.ncbi.nlm.nih.gov

Up-front neck dissection followed by definitive (chemo)-radiotherapy in head and neck squamous cell carcinoma: Rationale, complications, toxicity rates, and oncological outcomes - A systematic review. [2019] Lymph node metastases of head and neck cancer are considered one of the most negative prognostic factors. While outcomes and feasibility of chemo-radiotherapy ((C)RT) with or without adjuvant planned neck dissection (ND) in organ-preservation treatment strategy have been addressed, the role of ND before (C)RT, called up-front neck dissection (UFND), is not clearly established. This review provides a critical appraisal of UFND.

7. Germany pubmed.ncbi.nlm.nih.gov

Traditional risk factors and nodal yield-still relevant with high-quality risk-adapted adjuvant treatment for locally advanced head and neck cancer? [2023] Patients with locally advanced head and neck cancer (LAHNC) often undergo multimodal therapy including radical resection of the primary tumor and neck dissection (ND) followed by risk-adapted adjuvant radio(chemo)therapy (R(C)T). Quality parameters influencing local control and survival of these patients have been postulated: resection status (R status), extranodal extension (ENE), interval to adjuvant treatment ≤6 weeks, R(C)T given when indicated, and nodal yield (NY) ≥18 lymph nodes per neck. For other solid tumors the trend is towards less extensive lymph node surgery to avoid toxicity such as lymphedema, damage to peripheral nerves, dysesthesia, or paresthesia. The present study aims to investigate whether the number of nodes removed during neck dissection for LAHNC is still predictive for outcome when patients receive risk-adapted adjuvant treatment according to current guidelines.

8. United States pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety of Selective Neck Dissection in Lymph Node-Positive Squamous Cell Carcinoma of the Head and Neck. [2018] The aim of this study was to investigate the effectiveness and safety of selective neck dissection in patients with lymph node-positive head and neck squamous cell carcinoma to determine regional control and survival rates. Eighty patients with lymph node-positive head and neck squamous cell carcinoma who underwent selective dissection were included in the study. Regional control, survival rates, and factors affecting survival were analyzed. Regional control was 90%, disease-specific survival was 93.4%, and the overall survival rate was 87.25%. T stage, N stage, age, and extracapsular spread were included in hazard regression models. None of the factors were statistically significant. Selective neck dissection is an effective and oncologically safe treatment option in selected cases. T stage, N stage, and extracapsular spread had no significant impact on disease-specific survival.

9. United States pubmed.ncbi.nlm.nih.gov

Neck dissection: nomenclature, classification, and technique. [2011] Lymph node status is the single most important prognostic factor in head and neck cancer because lymph node involvement decreases overall survival by 50%. Appropriate management of the regional lymphatics, therefore, plays a central role in the treatment of the head and neck cancer patients. Performing an appropriate neck dissection results in minimal morbidity to the patient, provides invaluable data to accurately stage the patient, and guides the need for further therapy. The purposes of this article are to present the history and evolution of neck dissections, including an update on the current state of nomenclature and current neck dissection classification, describe the technique of the most common neck dissection applicable to oral cavity cancers, and discuss some of the complications associated with neck dissection. Finally, a brief review of sentinel lymph node biopsy will be presented.

10. England pubmed.ncbi.nlm.nih.gov

Role and extent of neck dissection for persistent nodal disease following chemo-radiotherapy for locally advanced head and neck cancer: how much is enough? [2009] Neck dissection (ND) is routinely performed for persistent nodal disease after definitive chemo-radiotherapy (CRT) for locally advanced head and neck cancer. This study analyzes the role and extent of ND necessary after CRT based on pathologic outcome.

11. United States pubmed.ncbi.nlm.nih.gov

Adequate lymph node assessment for extrahepatic bile duct adenocarcinoma. [2010] To examine the importance of adequate lymph node sampling in staging of extrahepatic bile duct cancer (EHBDCA).

12. United States pubmed.ncbi.nlm.nih.gov

Lymph node metastasis from hilar cholangiocarcinoma: audit of 110 patients who underwent regional and paraaortic node dissection. [2023] To assess the status of the regional and paraaortic lymph nodes in hilar cholangiocarcinoma and to clarify the efficacy of systematic extended lymphadenectomy.

13. England pubmed.ncbi.nlm.nih.gov

Regional lymphadenectomy vs. extended lymphadenectomy for hilar cholangiocarcinoma (Relay-HC trial): study protocol for a prospective, multicenter, randomized controlled trial. [2020] The prognostic benefits and safety of extended lymphadenectomy for hilar cholangiocarcinoma remain uncertain. The available evidence is still insufficient concerning its retrospective aspect. The aim of this study is to explore the clinical effect and safety of extended lymphadenectomy compared to regional lymphadenectomy in patients with hilar cholangiocarcinoma.