An interventional study of Neoadjuvant PDT + radical surgery and Radical surgery in Cholangiocarcinoma Resectable, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-04-01.
Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Not applicable, Interventional, and Treatment
For patients with locally advanced cholangiocarcinoma with resectable margins, patients who meet the selection criteria are randomly divided into two groups A and B. Group A: neoadjuvant PDT therapy combined with radical surgery; Group B: radical surgery. This study aims to explore the clinical effectiveness and safety of neoadjuvant photodynamic therapy for cholangiocarcinoma, as well as its role in destroying local tumors and enhancing systemic inflammation.
The average 5-year survival rate of patients with cholangiocarcinoma is about 5-10%. Only 30%-40% of patients have the opportunity to obtain radical surgery. Surgical resection is limited by the extent of tumor spread along the bile duct branches and segments, and the degree of involvement of the portal vein and (or) hepatic artery branches. Complete resection with negative margins (R0) is the only possible radical treatment. Only 60%-78% of radical surgery for cholangiocarcinoma are considered to achieve true R0 resection, and the tumor-free margin is often very short. Even after R0 resection, the recurrence rate is as high as 50%-76%. Photodynamic therapy is a tumor specific ablation method with small side effects and repeated treatments will not produce drug resistance. It provides a new prospect for the treatment of cholangiocarcinoma. For the current patients with locally advanced cholangiocarcinoma, neoadjuvant photodynamic therapy is used to make them resectable. Demotion and subsequent resection may potentially improve their results. Similarly, patients with resectable margins can benefit from tumor downgrading by increasing their chances of undergoing R0 resection. In order to increase the negative rate of resection margins, and to ensure sufficient tumor-free margins of the bile duct stumps, the research is still blank. For patients with locally advanced cholangiocarcinoma with resectable margins, patients who meet the selection criteria are randomly divided into two groups A and B. Group A: neoadjuvant PDT therapy combined with radical surgery; Group B: radical surgery. This study aims to explore the clinical effectiveness and safety of neoadjuvant photodynamic therapy, as well as its role in destroying local tumors and enhancing systemic inflammation.This study plans to enroll 50 patients. It is planned to complete the enrollment operation within 2 years, and the follow-up observation will be continued for 5 years after the operation. All patients are expected to complete neoadjuvant PDT treatment and radical surgery within 2 years, survival period (5 years survival rate), R0 resection rate and local recurrence rate are the main observation indicators, and the bilirubin level, the number of intraoperative freezing, the length of the tumor-free margin of the tumor tissue, and the incidence of complications (biliary leakage, cholangitis, phototoxicity) are the secondary observation indicators.
930 studies on the registry are indexed under Cholangiocarcinoma; 292 are open to participants now.
This study's planned enrollment of 50 is close to the median of 50 across 698 interventional studies indexed under Cholangiocarcinoma.
Browse Cholangiocarcinoma studies →First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 314 studies on the registry; 87 are open to participants now.
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Exclusion Criteria:
Child-Pugh C with hepatic encephalopathy Anyone with heart, lung, kidney dysfunction or other organ dysfunction, and cannot tolerate surgery.Hepatic ducts stone disease, who was diagnosed as Acute Cholangitis of Severe Type, especially complicated with bacteremia or septic shock. End stage disease, complicated with biliary cirrhosis or portal hypertension.Patients with long- term obstructive jaundice, dehydration, electrolyte disturbance or coagulation defects; Patients have the tendency or history of bleeding.
Photodynamic therapy for neoadjuvant treatment of cholangiocarcinoma
Procedure: Neoadjuvant PDT + radical surgery
Patients with cholangiocarcinoma undergo radical surgical resection
Procedure: Radical surgery
Patients with cholangiocarcinoma will undergo radical surgery after photodynamic therapy
Patients with cholangiocarcinoma will only receive radical surgery
R0 resection rate
Compare the incidence of positive margins of bile duct after surgical resection of cholangiocarcinoma between the two groups
Time frame: During operation
Local recurrence rate
Compare the local recurrence rate of cholangiocarcinoma between the two groups
Time frame: 1-year post operation
Survival time
Compare the 5-year survival time of the two groups
Time frame: 5-year post operation
Bilirubin level
Compare the Bilirubin level of the two groups
Time frame: 1,3,6,12-month post operation
Complication rate
Compare the incidence of bile leakage, cholangitis, phototoxicity and other complications between the two groups
Time frame: 1, 2,3,4,5,6,7,8-week Post operation
Tumor-free margin length
Compare the length of the tumor-free margin of the two groups of cholangiocarcinoma tissues
Time frame: During operation
Plan to share: No
This study is not yet recruiting, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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