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The goal of this clinical trial is to compare the overall survival of thermal ablation combined with chemotherapy and chemotherapy alone in the patients with liver oligometastasis after pancreatic ductal adenocarcinoma (PDAC) surgery.
The main question it aims to answer is: whether thermal ablation combined with chemotherapy can effectively prolong the overall survival in the patients with liver oligometastasis after pancreatic ductal adenocarcinoma (PDAC) surgery.
The participants in the treatment group will receive systemic chemotherapy combined with liver thermal ablation, while the participants in the control group will receive chemotherapy alone. All participants will be followed up to evaluate the overall survival after treatment.
How to improve the overall survival in the patients with liver oligometastasis after pancreatic ductal adenocarcinoma (PDAC) surgery is still a huge challenge in clinic. Chemotherapy is still the first-line treatment for patients with liver oligometastasis after PDAC resection. On the basis of chemotherapy, the clinical benefits of removing hepatic oligometastasis by thermal ablation are still unclear. In this study, we will recruit patients with liver oligometastasis after PDAC surgery to explore the effect of thermal ablation combined with chemotherapy on the overall survival of patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thermal Ablation | Experimental | In the patients with liver oligometastasis after pancreatic ductal adenocarcinoma (PDAC) surgery, thermal ablation and chemotherapy are administered. |
|
| Chemotherapy | Active Comparator | In the patients with liver oligometastasis after pancreatic ductal adenocarcinoma (PDAC) surgery, chemotherapy is administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thermal Ablation | Procedure | Thermal hepatic ablation Combined with Chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Time from enrollment to death | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival time | Time from thermal ablation to recurrence of liver lesion | 2 years |
| Procedure related complications | Relevant complication after thermal ablation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| pintong huang, Doctor | Contact | 0571-87783932 | huangpintong@zju.edu.cn | |
| jianting yao, Doctor | Contact | 0571-87783932 | yaojianting@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| pintong huang, Doctor | the 2th affiliated hospital of zhejiang university school of medicine | Study Chair |
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| ID | Term |
|---|---|
| D020728 | Transurethral Resection of Prostate |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D011468 | Prostatectomy |
| D013521 | Urologic Surgical Procedures, Male |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
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| Chemotherapy | Drug | Chemotherapy |
|
| up to 12 months |
| Procedure related mortality | up to 12 months |
| Patient satisfaction | Satisfaction questionnaire designed by investigator group | 2 years |
| Medical cost | Hospital expenditure | 2 years |
| Serum concentration of serological examinationof liver function | Serum concentration of tunmor biomarkers | 2 years |
| D013514 | Surgical Procedures, Operative |
| D013812 | Therapeutics |