Prospective Registry Of Therapeutic EndoscopiC ulTrasound

Chronic Pancreatitis Clinical Trial

— PROTECT  

Official title:

Prospective Registry Of Therapeutic EndoscopiC ulTrasound

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04813055
• Other study ID #: 178/INT/2020
• Status: Recruiting
• Start date: December 1, 2020
• Est. completion date: December 1, 2025

Study information

• Verified date: September 2023
• Source: IRCCS San Raffaele
• Contact: Giuseppe Vanella, MD
• Phone: +390226439574
• Email: vanella.giuseppe[@]hsr.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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:

• EUS-guided collection drainage

• EUS-guided biliary drainage

• EUS-guided gallbladder drainage

• EUS-guided gastro-enterostomy

• EUS-directed ERCP

• 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 510
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• subjects candidate to therapeutic EUS (T-EUS) procedures for any underlying disease

• 18 years old or older

• able to provide an informed consent to inclusion.

Exclusion Criteria:

• age < 18 years

• inability or unwillingness to sign the informed consent form (ICF)

• contra-indication for endoscopy or use of fluoroscopy

Related Conditions & MeSH terms

• Acute Cholecystitis
• Acute Pancreatic Fluid Collection
• Acute Pancreatitis With Infected Necrosis
• Biliary Obstruction
• Cholecystitis
• Cholecystitis, Acute
• Chronic Pancreatitis
• Gastric Outlet Obstruction
• Necrosis
• Pancreatitis
• Pancreatitis, Chronic
• Pyloric Stenosis

Intervention

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
• Percutaneous Procedures
Procedures involving a percutaneous access to a target region (fluid collection, gallbladder, biliary tree)
• 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)
• non-EUS-based endoscopic procedures
Other endoscopic procedures not involving EUS (enteral stenting, Enteroscopy-assisted ERCP)

Locations

Country	Name	City	State
Italy	IRCCS San Raffaele Scientific Institute	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Paolo Giorgio Arcidiacono, MD

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Technical success	Completion of the procedure through the correct positioning of the intended device in the target organ	1 day
Other	Recurrence	A new onset or a worsening of the condition which was palliated through the procedure, after an initial clinical success	12 months
Primary	Clinical Success	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.	30 days
Secondary	Adverse events	Any post-procedural complaint or complication requiring medical consultation or additional procedures, stratified according to American Society of Gastrointestinal Endoscopy Lexicon	12 months