Health Condition 1: K831- Obstruction of bile duct
Conditions
Interventions
Intervention1: EUS GUIDED BILIARY DRAINAGE: DRAINAGE BY PLACING METAL STENT BY EUS GUIDED TECHNIQUE.
Patient with periampullary neoplasm and pancreatic head cancer causing biliary obstruction will und
Sponsors
All India Institute of Medical Sciences Rishikesh
Eligibility
Inclusion criteria
Inclusion criteria: Radiological diagnosis (with or without pathological confirmation) of malignancy and presence of a malignant subhilar (at least 2cm distal to hilum) biliary obstruction and dilation of the upstream bile duct that is unresectable or the patient is inoperable due to high surgical risk as decided by the treating surgeon
Exclusion criteria
Exclusion criteria: 1-Age less than 18 years 2-Hilar biliary obstruction 3-Grade 3 cholangitis 4-Poor performance status 5-Pregnancy 6-Post biliary sphincterotomy status 7-Prior duodenal self-expanding metal stent 8-Liver metastasis of more than 30 % of liver volume 9-Gastric outlet obstruction 10-Prior ERCP and EUS with a stent in situ 11-Moderate to severe ascites on imaging
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the technical success of ERCP and EUS guided biliary drainage for primary drainage of unresectable subhilar malignant biliary obstruction. Technical success is defined as placement of metal stent and visual confirmation of flow of bile immediately after placing stent.Timepoint: baseline (preprocedure)and immediately after placement of stent | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-Procedure time-time (in mins) from the puncture of the bile duct to stent placement in the EUS-BD group, & from the time of biliary cannulation to stent placement in the ERCP group. 2-Clinical success- improvement in T-Bilirubin to less than 50% of the highest pretreatment values within 14 days after stent placement or less than 25% of the highest pretreatment values within 4 weeks and/or resolution of cholangitis if present preprocedure. 3-Duration of hospital stay- from placement of stent till discharge/death. 4-Procedure related adverse events- Adverse events attributable to a procedure within 14 days of the procedure. 5-Stent dysfunction rate- reappearance of cholangitis after resolution or increase in bilirubin by 50% from lowest level. 6- Stent patency - mean time in days from index procedure to stent dysfunction or migration 7- Reintervention rate- need for additional intervention within 1 month of the index procedure Timepoint: baseline, post procedure day 3,7,14,28 | — |
Countries
India
Contacts
Public ContactItish Patnaik
AIIMS RISHIKESH
Outcome results
None listed