Pancreas Necrosis, Pancreatic Collection
Conditions
Keywords
PANCREAS, ENDOSCOPIC INTERVENTION, PLASTIC STENT, SELF EXPANDING METALLIC STENT, ENDOSCOPIC TRANSMURAL DRAINAGE, WALLED OFF PANCREATIC NECROSIS
Brief summary
Randomized multicenter study comparing plastic stents and self-expanding metallic stents in the eus-guided transmural drainage of walled-off pancreatic necrosis. Spanish centers partners of the spanish society of digestive endoscopy.
Interventions
DEVICEWOPN TRANSMURAL DRAINAGE: PLASTIC STENT
Endoscopic ultrasound-guided transmural drainage of walled-off pancreatic necrosis: The pancreatic collection will be located with the linear echoendoscope, and we will proceed to choose an optimal area to perform the puncture guided by EUS; with the absence of intervening vessels. This collection will be punctured with a 19 G needle or with an electrocautery device directly. Guidance will be advanced through the needle and the ostomy will proceed according to the routine of the experienced endoscopist. Placement of a plastic double pigtail, 5-10 cm in length, diameters 7-8,5-10 Fr. Minimum one 10 Fr prosthesis. Arm associated: PLASTIC STENT
DEVICEWOPN TRANSMURAL DRAINAGE: METALLIC STENT
Endoscopic ultrasound-guided transmural drainage of walled-off pancreatic necrosis: The pancreatic collection will be located with the linear echoendoscope, and we will proceed to choose an optimal area to perform the puncture guided by EUS; with the absence of intervening vessels. This collection will be punctured with a 19 G needle or with an electrocautery device directly. Guidance will be advanced through the needle and the ostomy will proceed according to the routine of the experienced endoscopist. Placement of a metal self-expanding fully covered luminal apposition stent: 10, 15 or 20 mm diameter. Arm associated: SELF EXPANDABLE METALLIC STENT
Sponsors
Carlos III Health Institute
Spanish Clinical Research Network - SCReN
Hospital Universitari de Bellvitge
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age greater than or equal to 18 years * Patient with indication (ASGE, Jacobson BC, GIE2005;) of pancreatic collection drainage type WALLED-OFF PANCREATIC NECROSIS \* as a local complication of previous acute pancreatitis. * Patient trained to understand and / or sign informed consent * Patient who understands the type of study and will comply with all follow-up of complementary tests during its duration
Exclusion criteria
* Pregnancy or breastfeeding * Severe coagulation disorder: INR\> 1.5 not correctable with plasma and / or platelet administration \<50,000 / mm3 * Asymptomatic patients, with no clinical indication of drainage, except for those with vascular involvement due to compression (eg stenosis, splenic vessels with collateral circulation, and risk of bleeding) * Non-identification of solid content during the Endoscopic Ultrasound of the procedure * No informed consent * In the case of patients with mental retardation, without the ability to understand the nature and possible consequences of the study, except for the existence of a legal representative * Patients unable to maintain posterior follow-up (lack of adherence) * Situations that do not allow the practice of a high digestive endoscopy (eg, stenosis)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RADIOLOGICAL SUCCESS | 4 weeks | Radiological success at 4 weeks after the interventional procedure: reduction size of the wopn at least 50%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CLINICAL SUCCESS | 4 month | Evaluate the long-term clinical success (4 months) (metallic vs. plastic) determined by the total resolution or \<3cm of the WOPN, releated with clinical improvement. |
| TECHNICAL ASPECTS | 1st day | Evaluate the technical success, duration of the procedure and level of difficulty. |
| RECURRENCES | 4 weeks, 8 weeks, 4 month, 6 month, 8 month, 12 month | Evaluate recurrences |
| COSTS ANALYSIS | 12 month | Evaluate the costs between the two types of strategy |
| INCIDENCE OF TREATMENT-EMERGENT ADVERSE EVENTS [SAFETY AND TOLERABILITY] | 1st day, 24h, 7 days, 4 weeks, 8 weeks, 4 month, 6 month, 8 month, 12 month | Assess safety: complications (immediate, early and late) |
Other
| Measure | Time frame | Description |
|---|---|---|
| TECHNICAL ASPECTS | 1st day | Technical success: Correct release of the prosthesis (plastic or metallic) and drainage of the WOPN. |
Countries
Spain
Outcome results
None listed