EUS-guided Transmural Drainage of Walled-off Pancreatic Necrosis: Plastic vs Metallic Protesis.

Pancreas Necrosis Clinical Trial

— PROMETHEUS  

Official title:

Randomized Multicenter Study Comparing Plastic Stents and Self-expanding Metallic Stents Used in the Eus-guided Transmural Drainage of Walled-off Pancreatic Necrosis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03100578
• Other study ID #: PROMETHEUS
• Status: Completed
• Phase: N/A
• Start date: June 27, 2017
• Est. completion date: October 30, 2021

Study information

• Verified date: November 2021
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: October 30, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Necrosis
• Pancreas Necrosis
• Pancreatic Collection
• Pancreatitis, Acute Necrotizing

Intervention

Device:
• WOPN 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
• WOPN 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

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Arnau de Vilanova	Lleida	Barcelona
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Costa del Sol	Marbella	Málaga
Spain	Hospital San Juan de Dios	Pamplona	Navarra
Spain	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria
Spain	Hospital Universitario Río Hortega	Valladolid	Valldolid

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge	Carlos III Health Institute, Spanish Clinical Research Network - SCReN

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	TECHNICAL ASPECTS	Technical success: Correct release of the prosthesis (plastic or metallic) and drainage of the WOPN.	1st day
Other	TECHNICAL ASPECTS	Duration of the procedure: Minutes	1st day
Other	TECHNICAL ASPECTS	Level of difficulty: Easy, Medium, Hard, Very hard	1st day
Primary	RADIOLOGICAL SUCCESS	Radiological success at 4 weeks after the interventional procedure: reduction size of the wopn at least 50%.	4 weeks
Secondary	CLINICAL SUCCESS	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.	4 month
Secondary	TECHNICAL ASPECTS	Evaluate the technical success, duration of the procedure and level of difficulty.	1st day
Secondary	INCIDENCE OF TREATMENT-EMERGENT ADVERSE EVENTS [SAFETY AND TOLERABILITY]	Assess safety: complications (immediate, early and late)	1st day, 24h, 7 days, 4 weeks, 8 weeks, 4 month, 6 month, 8 month, 12 month
Secondary	RECURRENCES	Evaluate recurrences	4 weeks, 8 weeks, 4 month, 6 month, 8 month, 12 month
Secondary	COSTS ANALYSIS	Evaluate the costs between the two types of strategy	12 month