Deceased donor Liver Transplantation for Cholangiocarcinoma

Phase-Based Estimates
1
Effectiveness
2
Safety
University Health Network, Toronto, Canada
Cholangiocarcinoma+1 More
Deceased donor Liver Transplantation - Procedure
Eligibility
18+
All Sexes
Eligible conditions
Cholangiocarcinoma

Study Summary

This study is evaluating whether liver transplant is a good treatment for very early intrahepatic cholangiocarcinoma.

See full description

Eligible Conditions

  • Cholangiocarcinoma
  • Intrahepatic Cholangiocarcinoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Deceased donor Liver Transplantation will improve 1 primary outcome and 1 secondary outcome in patients with Cholangiocarcinoma. Measurement will happen over the course of 5 years.

5 years
5 year patient survival
disease recurrence after liver transplantation

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Compared to trials

Trial Design

2 Treatment Groups

Control
Liver transplantation

This trial requires 30 total participants across 2 different treatment groups

This trial involves 2 different treatments. Deceased Donor Liver Transplantation is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Liver transplantation
Procedure
The intervention will consist of liver transplantation
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 5 years for reporting.

Closest Location

University Health Network - Toronto, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The patient has no cancer-related symptoms. show original
The patient is not eligible for a liver resection because of their poor liver function and portal hypertension. show original
For women of childbearing potential, a negative serum pregnancy test means that they are not pregnant. show original
requires closer follow-up A biopsy has shown that there is cancer in the tissue (iCCa), and it is very early stage (single ≤2 cm) show original
There were no signs of vascular or biliary problems in the preoperative images. show original
No one with a score of 0 or 1 is eligible for a liver transplant. show original
Liver cirrhosis (any etiology)
Biopsy proven "very early" intrahepatic cholangiocarcinoma (iCCA)
The subject is willing and able to provide written informed consent. show original
Preoperative imaging showed no extra-hepatic disease. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get cholangiocarcinoma a year in the United States?

Add answer

In total more than 21,000 cholangiocarcinomas are diagnosed in the United States each year. The prevalence of cholangiocarcinoma appears to be increasing in the United States and probably in other industrialized countries since data acquisition on [liver cancer](https://www.withpower.com/clinical-trials/liver-cancer) began in the middle of the 20th century. The most common age of diagnosis is 70 yr; less common age groups for cholangiocarcinomas were in the early and middle decades of adulthood. Cholangiocarcinoma is the tenth most common cancer diagnosed in the United States in 2015, and it constitutes the 5th most common cause of cancer-related death in the US in 2015.

Unverified Answer

What are the signs of cholangiocarcinoma?

Add answer

CEA in excess of 3 times the upper threshold is a stronger indicator for cholangiocarcinoma than GGT. Other tests are not useful yet in confirming a diagnosis of cholangiocarcinoma.

Unverified Answer

What are common treatments for cholangiocarcinoma?

Add answer

A combination of surgery, portal vein embolization and neoadjuvant chemotherapy are frequently prescribed; they can alleviate, delay or even avoid surgical resection. For bile duct cancer, in the absence of metastases, resection is the only curative treatment, in which adjuvant chemotherapy is very rarely prescribed.

Unverified Answer

What is cholangiocarcinoma?

Add answer

If diagnosed, the median survival period in patients who have cholangiocarcinoma after surgical resection is 26 months after the initial diagnosis. Cholangiocarcinoma is a rare cancer, and its incidence continues to increase in all countries. cholangiocarcinoma.

Unverified Answer

What causes cholangiocarcinoma?

Add answer

Cholangiocarcinoma most commonly occurs in the setting of long-standing inflammatory hepatic disease. Hepatic fibrosis, bile duct obstruction, and biliary cysts are known predisposing factors. This article emphasizes that cholangiocarcinoma should be considered in the differential diagnosis in patients with inflammation, including biliary stent implantation, if this is not contraindicated by tumor burden or symptoms. The pathophysiology of cholangiocarcinoma is not well understood but is an evolving field that is a major area of research.

Unverified Answer

Can cholangiocarcinoma be cured?

Add answer

The surgical treatment of the primary tumor remains the main determinant of DSS in CCA with resection still demonstrating the single greatest prognostic effect in CCA, whereas in other cholangiocarcinomas resection has only a limited and most often no prognostic impact.

Unverified Answer

Have there been other clinical trials involving deceased donor liver transplantation?

Add answer

Although the majority of clinical trials published in the past half century that utilize LDLT have reported positive results, they have been limited by few patients numbers and short follow-up duration. Thus, further LDLT clinical trials should be undertaken to evaluate long-term outcome in LDLT recipients.

Unverified Answer

What are the chances of developing cholangiocarcinoma?

Add answer

Cholangiocarcinoma is a rare disease with high mortality. The disease is more common in men than women. The average age at the time of diagnosis is 61 years. The 5-year survival rate is 50%. A study by the Korean Working Group for Cirrhosis showed that cholangiocarcinoma was more likely to develop in patients who had a viral infection for a long time and were an alcoholic. There may be a link between cholangiocarcinoma and viral cholangitis. Patients with more than 10 years of liver cirrhosis must be closely monitored for the progression of the disease.

Unverified Answer

What does deceased donor liver transplantation usually treat?

Add answer

This is the largest study to be done on deceased donor liver transplantation. A significant proportion of recipients with advanced chronic liver diseases can be successfully transplanted using this technique.

Unverified Answer

What is the latest research for cholangiocarcinoma?

Add answer

Cholangiocarcinoma (CC) is a fatal, yet rapidly developing malignant neoplasm of hepatic biliary ducts (the common bilaterality of primary CCs and metastatic or metastatic/localized CCA occur frequently in both the human population). CCs are common tumours arising in the perihilar region of the common bile duct (CBD) and account for approximately 5-10% of all cancers in the liver.

Unverified Answer

Is deceased donor liver transplantation safe for people?

Add answer

The current study suggests that deceased donor liver [transplant](https://www.withpower.com/clinical-trials/transplant)ation performed in liver transplant centers is safe and shows a high survival rate in selected patients. Age over 65 years, male gender, and high model for end stage liver disease score are independent risk factors for mortality at least in the 90 days after transplantation.

Unverified Answer

What is deceased donor liver transplantation?

Add answer

Our preliminary results show that DDLT is safe, provided that the recipient and donor's health issues do not preclude transplant surgery. In addition, DDLT is an effective therapy for cholangiocarcinoma that can significantly improve the prognosis of recipients. However, the development of strategies to prevent cholangiocarcinoma will be a priority to further verify this therapy as a new standard for cholangiocarcinoma.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Cholangiocarcinoma by sharing your contact details with the study coordinator.