Gastric Outlet ObstructionPROTECTNCT04813055
Prospective Registry Of Therapeutic EndoscopiC ulTrasound
An observational study of Gastric Outlet Obstruction and Biliary Obstruction, run by Paolo Giorgio Arcidiacono, MD at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Outlet Obstruction, Biliary Obstruction, Acute Pancreatic Fluid Collection
- What is being tested?
- Therapeutic EUS, Percutaneous Procedures and Surgical Interventions
- Type of treatment
- Surgery or procedure
- How many people
- 510 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2020to 31 Dec 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients referred for any condition treatable by therapeutic EUS procedures, benign or malignant, as first intention or after failure of other procedures.
Who may be able to join
- subjects candidate to therapeutic EUS (T-EUS) procedures for any underlying disease
- subject eligible to T-EUS procedures but undergoing other non-EUS based endoscopic procedures, percutaneous or surgical procedures
- 18 years old or older
- able to provide an informed consent to inclusion.
Who cannot join
- age < 18 years
- inability or unwillingness to sign the informed consent form (ICF)
- contra-indication for endoscopy or use of fluoroscopy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS San Raffaele Scientific Institute
Milan, 20132
Giuseppe Vanella, MD, +390226439574, vanella.giuseppe@hsr.it
About this study
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.
The study also includes standard alternatives to T-EUS procedures for outcomes comparison.
Read the 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:
- 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.
Patients eligible for the abovementioned clinical indications, but undergoing alternative procedures (e.g. other endoscopic procedures, surgical interventions or percutaneous interventions) will be enrolled in the registry as "controls" according to specific research questions.
The same variables will be collected, with the exception of technical variables related to the EUS-guided intervention.
- Conditions
- Gastric Outlet Obstruction, Biliary Obstruction, Acute Pancreatic Fluid Collection, Acute Pancreatitis With Infected Necrosis, Acute Cholecystitis, Chronic Pancreatitis
- Being tested
- Therapeutic EUS, Percutaneous Procedures, Surgical Interventions, non-EUS-based endoscopic procedures
- Keywords
- Endoscopic ultrasound, Therapeutic EUS, Interventional EUS, Biliary Drainage, Gastro-jejunostomy, Gallbladder Drainage, Endoscopy
- Medical subject headings
- Gastric Outlet Obstruction, Cholecystitis, Acute, Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic EUSProcedure or surgery
- 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 ProceduresProcedure or surgery
Procedures involving a percutaneous access to a target region (fluid collection, gallbladder, biliary tree)
Surgical InterventionsProcedure or surgery
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 proceduresProcedure or surgery
Other endoscopic procedures not involving EUS (ERCP with stenting; enteral stenting, Enteroscopy-assisted ERCP)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Therapeutic EUS | |
| Controls | Patients eligible for T-EUS procedures, but undergoing non-EUS based endoscopic procedures (e.g. ERCP or enteral stenting), surgical interventions or percutaneous interventions (e.g. Percutaneous Biliary Drainage) Receives: Procedure: Percutaneous Procedures; Procedure: Surgical Interventions; Procedure: non-EUS-based endoscopic procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success
- EUS-guided collection drainage: Resolution or reduction of > 50% of fluid collections
- EUS-guided biliary drainage [valid also for ERCP with stenting]: Reduction of >50% 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 [valid also for enteral stenting]: 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.
Measured: 30 days
Secondary outcomes (1)
Adverse events
Any post-procedural complaint or complication requiring medical consultation or additional procedures, stratified according to American Society of Gastrointestinal Endoscopy Lexicon
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start1 Dec 2020
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Gastric Outlet ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 510 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Paolo Giorgio Arcidiacono, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paolo Giorgio Arcidiacono, MD, IRCCS San Raffaele
- Investigators
- Paolo Giorgio Arcidiacono, MD, FASGE, Principal investigator, IRCCS San Raffaele Scientific Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04813055
- Sponsor's protocol ID
- PROTECT
- Acronym
- PROTECT
- Status last verified
- Apr 2026
- First submitted
- 21 Mar 2021
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 32950747Teoh 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.
PubMed 29463614Vanella G, Frigo F, Perelli F, Bara R, Maisonneuve P, Archibugi L, Tacelli M, Lauri G, Bellafante D, Bina N, Nunziata R, Biamonte P, Ponz De Leon Pisani R, Capurso G, Arcidiacono PG. The Learning Curve of Junior Endoscopists in EUS-Guided Gastroenterostomy With the Wireless Simplified Technique: A Prospective Study. United European Gastroenterol J. 2026 Mar;14(2):e70170. doi: 10.1002/ueg2.70170.
PubMed 41820242Vanella G, Frigo F, Leone R, Rossi G, Zaccari P, Stasio RC, Archibugi L, Petrone MC, Tacelli M, Palumbo D, Guazzarotti G, Bronswijk M, van Wanrooij RLJ, Guarneri G, Tamburrino D, Preatoni P, Ratti F, Catena M, Van der Merwe S, Falconi M, Capurso G, De Cobelli F, Arcidiacono PG. EUS-guided drainage of Post-Surgical versus Post-Pancreatitis collections (the RESPELL study): A prospective comparison of clinical presentations and therapeutic outcomes. Dig Liver Dis. 2026 Apr;58(4):493-502. doi: 10.1016/j.dld.2026.01.010. Epub 2026 Jan 22.
PubMed 41577578Vanella G, Frigo F, Perelli F, Bara R, Leone R, Stasio RC, Maisonneuve P, Partelli S, Aleotti F, Orsi G, Macchini M, Balzano G, Reni M, Falconi M, Capurso G, Arcidiacono PG. Long-term outcomes of endoscopic ultrasound-guided gastroenterostomy: a prospective cohort study tracking symptom recurrence, reintervention timelines, and stent modifications over time. Gastrointest Endosc. 2026 Aug;104(2):242-252.e5. doi: 10.1016/j.gie.2026.01.007. Epub 2026 Jan 16.
PubMed 41548724Vanella G, Leone R, Frigo F, Bronswijk M, van Wanrooij RLJ, Tamburrino D, Orsi G, Belfiori G, Macchini M, Reni M, Aldrighetti L, Falconi M, Capurso G, van der Merwe S, Arcidiacono PG. Endoscopic ultrasound-guided choledochoduodenostomy versus hepaticogastrostomy combined with gastroenterostomy in malignant double obstruction (CABRIOLET_Pro): A prospective comparative study. DEN Open. 2024 Oct 6;5(1):e70024. doi: 10.1002/deo2.70024. eCollection 2025 Apr.
PubMed 39377069
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registry Of Therapeutic EndoscopiC ulTrasound
- ClinicalTrials.gov ID
- NCT04813055
- Acronym / sponsor ID
- PROTECT / PROTECT
- Conditions
- Gastric Outlet Obstruction, Biliary Obstruction, Acute Pancreatic Fluid Collection, Acute Pancreatitis With Infected Necrosis, Acute Cholecystitis, Chronic Pancreatitis
- Keywords
- Endoscopic ultrasound, Therapeutic EUS, Interventional EUS, Biliary Drainage, Gastro-jejunostomy, Gallbladder Drainage, Endoscopy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 510 participants (estimated)
- Lead sponsor
- Paolo Giorgio Arcidiacono, MDUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
The study also includes standard alternatives to T-EUS procedures for outcomes comparison.
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:
- 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.
Patients eligible for the abovementioned clinical indications, but undergoing alternative procedures (e.g. other endoscopic procedures, surgical interventions or percutaneous interventions) will be enrolled in the registry as "controls" according to specific research questions.
The same variables will be collected, with the exception of technical variables related to the EUS-guided intervention.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic EUS | – | Procedure: Therapeutic EUSProcedures 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. |
| Controls | – | Procedure: Percutaneous Procedures, Procedure: Surgical Interventions, Procedure: non-EUS-based endoscopic proceduresPatients eligible for T-EUS procedures, but undergoing non-EUS based endoscopic procedures (e.g. ERCP or enteral stenting), surgical interventions or percutaneous interventions (e.g. Percutaneous Biliary Drainage) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients referred for any condition treatable by therapeutic EUS procedures, benign or malignant, as first intention or after failure of other procedures.
Key inclusion criteria (4 listed)
- subjects candidate to therapeutic EUS (T-EUS) procedures for any underlying disease
- subject eligible to T-EUS procedures but undergoing other non-EUS based endoscopic procedures, percutaneous or surgical procedures
- 18 years old or older
- able to provide an informed consent to inclusion.
Key exclusion criteria (3 listed)
- age < 18 years
- inability or unwillingness to sign the informed consent form (ICF)
- contra-indication for endoscopy or use of fluoroscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic EUS1. EUS-guided collection drainage (transgastric or transduodenal, performed by Lumen Apposing Metal Stents or double pigtail stents) and eventual endoscopic necrosectomy 2. 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). 3. EUS-guided gallbladder drainage via Lumen Apposing Metal Stents and eventual subsequent EUS-based cholecystolithotomy 4. EUS-guided gastro-jejunostomy through Lumen Apposing Metal Stents 5. EUS-directed ERCP in post-surgical anatomy (by gastro-gastrostomy or entero-enterostomy performed through Lumen Apposing Metal Stents) 6. EUS-guided pancreatic duct drainage | Procedure or surgery | Therapeutic EUS |
| Percutaneous ProceduresProcedures involving a percutaneous access to a target region (fluid collection, gallbladder, biliary tree) | Procedure or surgery | Controls |
| Surgical InterventionsSurgical interventions to obtain a drainage (e.g. surgical necrosectomy, pancreatico-gastrostomy) or the bypass of a stricture (hepatico-jejunostomy or gastro-jejunostomy) | Procedure or surgery | Controls |
| non-EUS-based endoscopic proceduresOther endoscopic procedures not involving EUS (ERCP with stenting; enteral stenting, Enteroscopy-assisted ERCP) | Procedure or surgery | Controls |
Primary outcome
Clinical Success
Time frame: 30 days
* EUS-guided collection drainage: Resolution or reduction of > 50% of fluid collections * EUS-guided biliary drainage [valid also for ERCP with stenting]: Reduction of >50% 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 [valid also for enteral stenting]: 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.
1 secondary outcome
Adverse events
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Background: PubMed 32950747DeWitt 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.
- Background: PubMed 29463614Teoh 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.
- Derived from this study: PubMed 41820242Vanella G, Frigo F, Perelli F, Bara R, Maisonneuve P, Archibugi L, Tacelli M, Lauri G, Bellafante D, Bina N, Nunziata R, Biamonte P, Ponz De Leon Pisani R, Capurso G, Arcidiacono PG. The Learning Curve of Junior Endoscopists in EUS-Guided Gastroenterostomy With the Wireless Simplified Technique: A Prospective Study. United European Gastroenterol J. 2026 Mar;14(2):e70170. doi: 10.1002/ueg2.70170.
- Derived from this study: PubMed 41577578Vanella G, Frigo F, Leone R, Rossi G, Zaccari P, Stasio RC, Archibugi L, Petrone MC, Tacelli M, Palumbo D, Guazzarotti G, Bronswijk M, van Wanrooij RLJ, Guarneri G, Tamburrino D, Preatoni P, Ratti F, Catena M, Van der Merwe S, Falconi M, Capurso G, De Cobelli F, Arcidiacono PG. EUS-guided drainage of Post-Surgical versus Post-Pancreatitis collections (the RESPELL study): A prospective comparison of clinical presentations and therapeutic outcomes. Dig Liver Dis. 2026 Apr;58(4):493-502. doi: 10.1016/j.dld.2026.01.010. Epub 2026 Jan 22.
- Derived from this study: PubMed 41548724Vanella G, Frigo F, Perelli F, Bara R, Leone R, Stasio RC, Maisonneuve P, Partelli S, Aleotti F, Orsi G, Macchini M, Balzano G, Reni M, Falconi M, Capurso G, Arcidiacono PG. Long-term outcomes of endoscopic ultrasound-guided gastroenterostomy: a prospective cohort study tracking symptom recurrence, reintervention timelines, and stent modifications over time. Gastrointest Endosc. 2026 Aug;104(2):242-252.e5. doi: 10.1016/j.gie.2026.01.007. Epub 2026 Jan 16.
- Derived from this study: PubMed 39377069Vanella G, Leone R, Frigo F, Bronswijk M, van Wanrooij RLJ, Tamburrino D, Orsi G, Belfiori G, Macchini M, Reni M, Aldrighetti L, Falconi M, Capurso G, van der Merwe S, Arcidiacono PG. Endoscopic ultrasound-guided choledochoduodenostomy versus hepaticogastrostomy combined with gastroenterostomy in malignant double obstruction (CABRIOLET_Pro): A prospective comparative study. DEN Open. 2024 Oct 6;5(1):e70024. doi: 10.1002/deo2.70024. eCollection 2025 Apr.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paolo Giorgio Arcidiacono, MD, FASGE principal investigator
IRCCS San Raffaele Scientific Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Outlet Obstruction and Biliary Obstruction, run by Paolo Giorgio Arcidiacono, MD at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Vanella, MD (+390226439574, vanella.giuseppe@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Success (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04813055, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.