PROTECT: Prospective Registry Of Therapeutic EndoscopiC ulTrasound
Study Details
Study Description
Brief Summary
This registry aims to analyze long-term outcomes of therapeutic EUS (T-EUS) procedures, as well as to describe clinical and technical variables potentially predicting clinical success or adverse events, for a better selection of ideal candidates.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
This is an observational, prospective, single centre study. This registry aims to evaluate long-term clinical success of EUS-guided therapeutic interventions (T-EUS), as well as adverse events, and clinical and technical variables asociated with clinical success and adverse events.
For the purpose of this registry, the following procedures will be considered to be T-EUS procedures:
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EUS-guided collection drainage
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EUS-guided biliary drainage
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EUS-guided gallbladder drainage
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EUS-guided gastro-enterostomy
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EUS-directed ERCP
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EUS-guided pancreatic duct drainage
Each patient will be assigned to a procedure following standard clinical practice, in most instances following a routinely multidisciplinary discussion.
All patients eligible for the abovementioned clinical indications, but finally undergoing alternative procedures (e.g. surgical interventions, percutaneous interventions or other endoscopic procedures) will be proposed to be enrolled in the registry as "controls". The same variables will be collected, with the exception of technical variables related to the EUS-guided intervention.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Therapeutic EUS Procedures involving Linear Echoendoscopes to create a communication between the gastrointestinal tract and a target organ (biliary tree, pancreatic duct, fluid collection, gallbladder, downstream gastrointestinal tract) through plastic or metal stents. |
Procedure: Therapeutic EUS
EUS-guided collection drainage (transgastric or transduodenal, performed by Lumen Apposing Metal Stents or double pigtail stents) and eventual endoscopic necrosectomy
EUS-guided biliary drainage (either of the extrahepatic or intrahepatic biliary tree / transduodenal or transgastric / either as access for subsequent rendez-vous or transpapillary stenting OR for transparietal stenting by metal or plastic stents).
EUS-guided gallbladder drainage via Lumen Apposing Metal Stents and eventual subsequent EUS-based cholecystolithotomy
EUS-guided gastro-jejunostomy through Lumen Apposing Metal Stents
EUS-directed ERCP in post-surgical anatomy (by gastro-gastrostomy or entero-enterostomy performed through Lumen Apposing Metal Stents)
EUS-guided pancreatic duct drainage
|
| Controls Patients eligible for T-EUS procedures, but undergoing alternative surgical interventions, percutaneous interventions (e.g. Percutaneous Biliary Drainage) or non-EUS based endoscopic procedures (e.g. enteral stenting) |
Procedure: Percutaneous Procedures
Procedures involving a percutaneous access to a target region (fluid collection, gallbladder, biliary tree)
Procedure: Surgical Interventions
Surgical interventions to obtain a drainage (e.g. surgical necrosectomy, pancreatico-gastrostomy) or the bypass of a stricture (hepatico-jejunostomy or gastro-jejunostomy)
Procedure: non-EUS-based endoscopic procedures
Other endoscopic procedures not involving EUS (enteral stenting, Enteroscopy-assisted ERCP)
|
Outcome Measures
Primary Outcome Measures
- Clinical Success [30 days]
EUS-guided collection drainage: Resolution or reduction of > 50% of fluid collections EUS-guided biliary drainage: Reduction of >25% of bilirubin OR management of choledocholithiasis OR resolution of cholangitis EUS-guided gallbladder drainage: Improvement of clinical symptoms or relief of inflammatory signs/symptoms related to cholecystitis EUS-guided gastro-jejunostomy: Resumption of oral intake (Gastric Outlet Obstruction Scoring System >/= 2 id est at least semisolid food) EUS-directed ERCP: Possibility to perform ERCP EUS-guided pancreatic duct drainage: Relief of abdominal pain and reduction of analgesic drug requirement during follow-up OR reduction in the rate of recurrent pancreatitis.
Secondary Outcome Measures
- Adverse events [12 months]
Any post-procedural complaint or complication requiring medical consultation or additional procedures, stratified according to American Society of Gastrointestinal Endoscopy Lexicon
Other Outcome Measures
- Technical success [1 day]
Completion of the procedure through the correct positioning of the intended device in the target organ
- Recurrence [12 months]
A new onset or a worsening of the condition which was palliated through the procedure, after an initial clinical success
Eligibility Criteria
Criteria
Inclusion Criteria:
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subjects candidate to therapeutic EUS (T-EUS) procedures for any underlying disease
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18 years old or older
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able to provide an informed consent to inclusion.
Exclusion Criteria:
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age < 18 years
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inability or unwillingness to sign the informed consent form (ICF)
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contra-indication for endoscopy or use of fluoroscopy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | IRCCS San Raffaele Scientific Institute | Milan | Italy | 20132 |
Sponsors and Collaborators
- Paolo Giorgio Arcidiacono, MD
Investigators
- Principal Investigator: Paolo Giorgio Arcidiacono, MD, FASGE, IRCCS San Raffaele Scientific Institute
Study Documents (Full-Text)
None provided.More Information
Publications
- DeWitt JM, Arain M, Chang KJ, Sharaiha R, Komanduri S, Muthusamy VR, Hwang JH; AGA Center for GI Innovation and Technology. Interventional Endoscopic Ultrasound: Current Status and Future Directions. Clin Gastroenterol Hepatol. 2021 Jan;19(1):24-40. doi: 10.1016/j.cgh.2020.09.029. Epub 2020 Sep 18.
- Teoh AYB, Dhir V, Kida M, Yasuda I, Jin ZD, Seo DW, Almadi M, Ang TL, Hara K, Hilmi I, Itoi T, Lakhtakia S, Matsuda K, Pausawasdi N, Puri R, Tang RS, Wang HP, Yang AM, Hawes R, Varadarajulu S, Yasuda K, Ho LKY. Consensus guidelines on the optimal management in interventional EUS procedures: results from the Asian EUS group RAND/UCLA expert panel. Gut. 2018 Jul;67(7):1209-1228. doi: 10.1136/gutjnl-2017-314341. Epub 2018 Feb 20.
- 178/INT/2020