Low malignant biliary obstruction
Conditions
Interventions
Control group:Preoperative drainage using a covered self-expansible metal stent
Experimental group:Preoperative drainage using double plastic stents
Sponsors
Department of Gastroenterology, Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
15 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients may choose to enter the study when they meet all of the following criteria: (1) Patients with pathological results showing periampullary tumors, assessed as resectable or junctionally resectable; (2) Patients with pathological diagnosis of low-level malignant biliary obstruction and need to reduce yellowing of ERCP before surgery.
Exclusion criteria
Exclusion criteria: Patients cannot be selected for clinical study when they have any of the following: (1) Patients with pathological diagnosis of unresectable malignant tumors; (2) hilar bile duct stenosis; (3) Combined with acute cholecystitis or obstructive pancreatitis; (4) Upper gastrointestinal surgery; (5) Presence of ERCP contraindications; (6) There are reasons why other researchers believe that it is not appropriate to participate in clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of stent failure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Stent patent time;The decrease of serum bilirubin of patients within 2 weeks after stent placement;Operation time required for the first-time stent placement and stent replacement by ERCP;Success rate of the first-time stent placement and stent replacement by ERCP;The total times of stent replacement within 1 year after the first stent placement in this research;Incidence of ERCP-related adverse events;The interval between stent placement and the resection surgery ;Success rate of resection surgery, time required for the resection surgery, volume of bleeding during the resection surgery, the incidence of surgery-related adverse events, incidence of postoperative adverse events, postoperative hospitalization stay, postoperative survival time;Medical expense for stent placement;The total medical expense;The total hospitalization stay; | — |
Countries
China
Contacts
Public ContactWang Qiang
Department of Gastroenterology, Peking Union Medical College Hospital
Outcome results
None listed