Unresectable Malignant Distal Biliary Obstruction
Conditions
Interventions
Fully-Covered Self Expandable Metallic stent group:Placement of Fully-Covered Self Expandable Metallic stent
Uncovered Self Expandable Metallic stent group:Placement of Uncovered Self Expandable Metallic stent
Sponsors
General Hospital of Northern Theater Command
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-80 years old; 2. Preoperative clear presence of obstructive jaundice with total bilirubin >3mg/dL, requiring clinical treatment; 3. Distal malignant biliary obstruction confirmed by pathology, imaging, biochemical tests or multidisciplinary joint consultation, and there is no possibility of surgical resection; or although there is a possibility of surgery, the patient and/or family members refused to undergo surgical treatment, and asked for palliative jaundice reduction treatment, which was fully informed and signed; 4. Be physically able to tolerate ERCP surgery as assessed by anesthesiologists and related clinicians; 5. Voluntarily participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Benign biliary tract stenosis; 2. Those with prior cholecystectomy; 3. Patients with pre-existing acute biliary infections (cholangitis, cholecystitis) or patients requiring emergency ERCP treatment; 4. Previous ERCP stenting; 5. Patients with previous partial gastrectomy and upper gastrointestinal tract reconstruction surgery, who are difficult to perform routine ERCP; 6. Those who have undergone preoperative PTBD, PTBD or other means of biliary drainage; 7. Known definite coagulation disorders (abnormal coagulation function, platelets <50*109/L, hemophilia, etc.); 8. Those who do not wish to be enrolled in this trial or cannot be followed up; 9. Special populations: pregnant women, lactating women, patients with mental disorders, etc; 10. Those who have been treated with other anti-tumor therapies such as chemotherapy, radiotherapy, targeted therapy, etc. before surgery; 11. Those who are unable to define the nature of bile duct occupancy, and the nature of occupancy cannot be defined even after more than half a year of dynamic follow-up after treatment; 12. Those who are considered by the investigator to be unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of postoperative cholecystitis ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Survival Time;Operation success rate;Clinical Success rate;Postoperative pancreatitis ;Postoperative Bleeding;Perforation;Stent Migration;Stent Occlusion;Endoscopic Re-intervention Rate; | — |
Countries
China
Contacts
Public ContactZhuo Yang
General Hospital of Northern Theater Command
Outcome results
None listed