Advanced biliary tract tumor
Conditions
Interventions
experimental group:Three-dimensional imaging segmentation system +ERCP/PTCD
control group:conventional dual-source CT+ERCP/PTCD treatment
Sponsors
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: A. Age: 18-80 years old, Asian; B. Stable vital signs, ECOG score 0-1; C. Patients diagnosed by histopathology or cytology are not suitable for radical surgery (R0), non-radical surgery (R1), advanced palliative surgery, or recurrent metastatic biliary malignancy; D. Feasible abdominal dual-source CT and three-dimensional imaging examination; E. According to the evaluation criteria of RECIST version 1.1, there should be at least one measurable and evaluable objective lesion (the longest diameter of the target lesion detected by spiral CT >= 10mm; If there is only lymph node metastasis, the minimum diameter shall be >= 15mm); F. Expected survival >= 12 weeks; G. Volunteered for this study, signed informed consent form, such as the subjects could not read or sign, is under the condition of the subjects were informed consent signed by the legal agent informed consent, the inability to express consent of the subjects, his legal representative is to provide the above introduction and explanation, and signed by the legal agent informed consent;Good compliance; H. Willingness of patients of childbearing age and their spouses to use contraception.
Exclusion criteria
Exclusion criteria: A. Before this study, I had received the following treatments: a. Previous history of digestive tract reconstruction surgery; b. Previous ERCP/PTCD treatment; c. Participating in other therapeutic/intervention clinical trials; B. Brain metastasis or pia metastasis; C. A history of malignancy other than biliary tract malignancy (except cervical carcinoma in situ or basal cell carcinoma of the skin that has been cured and other malignancies that have been cured for 5 years); D. With other serious medical conditions, including but not limited to: a. Uncontrolled congestive heart failure (NYHA grade III or IV), unstable angina, poorly controlled arrhythmia, uncontrolled moderate or higher hypertension (SBP>160mmHg or DBP>100mmHg); b. Active infection; c. Uncontrolled diabetes; d. IV infection; e. Patients with interstitial pneumonia or low oxygen saturation; f. Chronic steroid use is required for active autoimmune diseases; g. Patients who have received allografts; h. Mental illness affecting informed consent and/or programme compliance; i. In patients with severe cirrhosis, thrombotic dysfunction (INR>1.3) and peripheral blood platelet count decreased significantly < 50x10^9/L. H. There are serious diseases that other researchers consider inappropriate to participate in this study; I. Known allergy to the drug involved in the study; J. Other contraindications to ERCP/PTCD.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraoperative improvement;PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Operation time;Intraoperative bleeding;Average length of stay;X-ray exposure time;Short-termed complications ;OS; | — |
Countries
China
Contacts
Public ContactShu Yijun
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed