ENDOSCOPIC ULTRASONOGRAPHY
Conditions
Brief summary
Endoscopic ultrasound guided drainage of WON with metal stent is the mainstay of WON management. But there are few complications related to BFMS , like bleeding due to vessel erosion, stent clogging , stent migration . This study is to assess, whether placing an anchoring DPS through the BFMS will decrease adverse events or not. There are only 2 retrospective studies till date ,comparing LAMS with coaxial stent vs LAMS alone. one study showed no significant decrease in adverse events , one study showed decrease in adverse events when DPS with LAMS . But there has been no prospective RCT to assess the utility of DPS to date
Detailed description
Inclusion Criteria: - 1. Symptomatic Walled-off pancreatic necrosis (WON) 2. Eligible for EUS guided BFMS placement 3. Signed informed consent . 4. Age \>18 Years Exclusion Criteria: - 1. Types of pancreatic collections other than WON . 2. Drainage with stents other than BFMS 3. Previous attempts at drainage of WON 4. Coagulopathy (INR\>1.5) or thrombocytopenia(plc \<50000/cmm)- not correctable. 5. Pregnancy 6. Not willing to give informed consent
Interventions
PROCEDUREEndoscopic ultrasound guided drainage of walled off pancreatic necrosis
It is Therapeutic procedure to treat walled off pancreatic necrosis.
Sponsors
Asian Institute of Gastroenterology, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Symptomatic Walled-off pancreatic necrosis (WON) 2. Eligible for EUS guided BFMS placement 3. Signed informed consent . 4. Age \>18 Years
Exclusion criteria
1. Types of pancreatic collections other than WON . 2. Drainage with stents other than BFMS 3. Previous attempts at drainage of WON 4. Coagulopathy (INR\>1.5) or thrombocytopenia(plc \<50000/cmm)- not correctable. 5. Pregnancy 6. Not willing to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse evens rates associated with both the groups ( stent clogging and stent migration, bleeding). | 4 weeks | To monitor the adverse events like bleeding, stent clogging and stent migration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| re-intervention rates | 4 weeks | Number of sessions of Direct Endoscopic necrosectomy and De clogging of stent |
| Technical success rate | 4 weeks | Deployment of Stent |
| Clinical success rate | 4 weeks | Resolution of symptoms Resolution of size of walled of necrosis |
Countries
India
Outcome results
None listed