Therapeutic Endoscopic UltrasoundTEUS RegistryNCT05051358
Therapeutic Endoscopic Ultrasound for Gastrointestinal Disorders: A Multicenter Registry Study
An observational study of Therapeutic Endoscopic Ultrasound and Advanced Endoscopy, run by Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University at 1 site in United States.
Trial summary
The purpose of this retrospective chart-review registry study is to evaluate the safety profile, efficacy profile and cost-effectiveness of the various therapeutic endoscopic ultrasound (EUS) procedures (for benign and malignant gastrointestinal disorders). 1. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Therapeutic Endoscopic Ultrasound, Advanced Endoscopy, Therapeutic Endoscopy
- What is being tested?
- Therapeutic Endoscopic Ultrasound
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2021to 10 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects undergoing Interventional Therapeutic Endoscopic Ultrasound Procedures for Gastrointestinal indications
Who may be able to join
- Subjects undergoing Interventional Therapeutic Endoscopic Ultrasound Procedures for Gastrointestinal indications
Who cannot join
- Subjects not undergoing Interventional Therapeutic Endoscopic Ultrasound Procedures for Gastrointestinal indications
Trial locations and contacts
1 site in 1 country.
United States1 site
Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University
New Brunswick, New Jersey, 08901
About this study
Official title: Therapeutic Endoscopic Ultrasound for Gastrointestinal Disorders: A Multicenter Registry
The purpose of this retrospective chart-review registry study is to evaluate the safety profile, efficacy profile and cost-effectiveness of the various therapeutic endoscopic ultrasound (EUS) procedures (for benign and malignant gastrointestinal disorders).
- To assess the clinical and technical success rates of EUS-Guided interventions
- To document the impact of therapeutic EUS procedures on the management of gastrointestinal disorders including malignancies through cost effective analyses.
- Compare endoscopic interventions to non-endoscopic interventions for the same clinical indications and evaluate safety and efficacy.
Read the detailed description
Our tertiary-care institution performs clinically-indicated therapeutic Endoscopic Ultrasound (TEUS) guided interventions, including biliary and pancreatic drainage, for both malignant and benign gastrointestinal indications in more than 2000 patients annually.
Procedures such as biliary and/or pancreatic sphincterotomy, stents placement (metallic or plastic) and removal for revision, cysts and pseudocysts drainage are conducted in patients suffering from pancreatico-biliary disorders, gastrointestinal disorders and esophageal disorders.
TEUS procedures are less invasive approach than surgery. Moreover, they can be available to patients who are ineligible for surgery or who have refused more aggressive surgical intervention.
They improve quality of life and extend survival duration.
Currently, there is limited multi-center data on therapeutic endoscopy clinical outcomes and standardized treatment algorithms in western populations. Due to continuing variations in therapeutic EUS procedures, as well as introduction of some TEUS procedure accessories; it is necessary to periodically evaluate the efficacy and safety of specific TEUS procedures and accessories for several indications to check for improved clinical outcomes.
Evaluation of these clinical details would help us compare them to conventional treatment modalities within our current facility and scope of practice; and consequently, help us identify safe and cost-effective treatment techniques, develop treatment algorithms and improve clinical management of patients at RWJMS and other tertiary-care centers.
- Conditions
- Therapeutic Endoscopic Ultrasound, Advanced Endoscopy, Therapeutic Endoscopy, Interventional Endoscopy, Interventional Endoscopic Ultrasound, Gastro-Intestinal Disorder
- Being tested
- Therapeutic Endoscopic Ultrasound
- Medical subject headings
- Digestive System Diseases, Gastrointestinal Diseases, Gastrointestinal Neoplasms, Digestive System Fistula, Pancreatic Diseases, Bile Duct Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Endoscopic UltrasoundProcedure or surgery
Therapeutic Endoscopic Ultrasound or Interventional Endoscopy for Gastrointestinal Indications
| Study group | Role | What they receive |
|---|---|---|
| Subjects undergoing Therapeutic Endoscopic Ultrasound | Procedures that will be captured include:
EUS- ERCP, Endoscopic Hepatology - EUS, EUS-Coils placement, EUS Glue injection, EUS-Fiducial placement, EUS-Neurolysis, EUS-Stent placement, EUS-alcohol injection, EUS-guided Ablation, EUS-guided anastomosis, EUS Guided ERCP for gallbladder, pancreatic duct or biliary duct drainage, EUS guided - Hemostasis, EUS guided- Therapy for cancer or premalignant lesion (Injection, neurolysis, fiducial, aspiration, RFA ), EUS - Fluid Collection, abscess or cavity drainage, EUS - Guided Ductal Drainage, EUS - Guided Anastomosis Receives: Procedure: Therapeutic Endoscopic Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Procedure
Technical and clinical success rates
Measured: Upto 2 years
Safety of procedure
Type, frequency and intensity of adverse events
Measured: Upto 2 years
Secondary outcomes (1)
Cost Effectiveness
Total cost associated with procedures
Measured: Upto 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start11 Feb 2021
- Primary completion10 Dec 2023 (estimated)
- Study completion10 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Therapeutic Endoscopic UltrasoundStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel Kahaleh, MD, Principal investigator, Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05051358
- Sponsor's protocol ID
- Pro2020002795
- Acronym
- TEUS Registry
- Status last verified
- May 2023
- First submitted
- 3 Sep 2021
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be made available to other out-of-site researchers
Publications
Karanfilian B, Tyberg A, Sarkar A, Shahid HM, Simon A, Reinoso K, Bapaye A, Gandhi A, Gadhikar HP, Dorwat S, Raina H, Ansari J, Nieto J, Qadir N, Porfilio MG, Arevalo-Mora M, Puga-Tejada M, Alcivar-Vasquez J, Robles-Medranda C, Ardengh JC, Bareket R, Liao K, Patel R, Pimpinelli S, Gaidhane M, Kahaleh M. Impact of COVID-19 Infection on Pancreato-Biliary Diseases Requiring Endoscopic Retrograde Cholangiopancreatography. Dig Dis Sci. 2024 Aug;69(8):3015-3018. doi: 10.1007/s10620-024-08454-1. Epub 2024 May 7.
PubMed 38713274Tyberg A, Duarte-Chavez R, Shahid HM, Sarkar A, Simon A, Shah-Khan SM, Gaidhane M, Mohammad TF, Nosher J, Wise SS, Needham V, Kheng M, Lajin M, Sojitra B, Wey B, Dorwat S, Raina H, Ansari J, Gandhi A, Bapaye A, Shah-Khan SM, Krafft MR, Thakkar S, Singh S, Bane JR, Nasr JY, Lee DP, Kedia P, Arevalo-Mora M, Del Valle RS, Robles-Medranda C, Puga-Tejada M, Vanella G, Ardengh JC, Bilal M, Giuseppe D, Arcidiacono PG, Kahaleh M. Endoscopic Ultrasound-Guided Gallbladder Drainage Versus Percutaneous Drainage in Patients With Acute Cholecystitis Undergoing Elective Cholecystectomy. Clin Transl Gastroenterol. 2023 Jun 1;14(6):e00593. doi: 10.14309/ctg.0000000000000593.
PubMed 37141073Tyberg A, Sarkar A, Shahid HM, Shah-Khan SM, Gaidhane M, Simon A, Eisenberg IA, Lajin M, Karagyozov P, Liao K, Patel R, Zhao E, Martinez MG, Artifon EL, Lino AD, Vanella G, Arcidiacono PG, Kahaleh M. EUS-Guided Biliary Drainage Versus ERCP in Malignant Biliary Obstruction Before Hepatobiliary Surgery: An International Multicenter Comparative Study. J Clin Gastroenterol. 2023 Oct 1;57(9):962-966. doi: 10.1097/MCG.0000000000001795.
PubMed 36730114
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Endoscopic Ultrasound for Gastrointestinal Disorders: A Multicenter Registry
- ClinicalTrials.gov ID
- NCT05051358
- Acronym / sponsor ID
- TEUS Registry / Pro2020002795
- Conditions
- Therapeutic Endoscopic Ultrasound, Advanced Endoscopy, Therapeutic Endoscopy, Interventional Endoscopy, Interventional Endoscopic Ultrasound, Gastro-Intestinal Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers UniversityUniversity, hospital or other
- Study start
- 11 Feb 2021 (actual)
- Primary completion
- 10 Dec 2023 (estimated)
- Study completion
- 10 Dec 2023 (estimated)
- First posted
- 21 Sep 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.
The purpose of this retrospective chart-review registry study is to evaluate the safety profile, efficacy profile and cost-effectiveness of the various therapeutic endoscopic ultrasound (EUS) procedures (for benign and malignant gastrointestinal disorders).
- To assess the clinical and technical success rates of EUS-Guided interventions
- To document the impact of therapeutic EUS procedures on the management of gastrointestinal disorders including malignancies through cost effective analyses.
- Compare endoscopic interventions to non-endoscopic interventions for the same clinical indications and evaluate safety and efficacy.
Detailed description
Our tertiary-care institution performs clinically-indicated therapeutic Endoscopic Ultrasound (TEUS) guided interventions, including biliary and pancreatic drainage, for both malignant and benign gastrointestinal indications in more than 2000 patients annually.
Procedures such as biliary and/or pancreatic sphincterotomy, stents placement (metallic or plastic) and removal for revision, cysts and pseudocysts drainage are conducted in patients suffering from pancreatico-biliary disorders, gastrointestinal disorders and esophageal disorders.
TEUS procedures are less invasive approach than surgery. Moreover, they can be available to patients who are ineligible for surgery or who have refused more aggressive surgical intervention.
They improve quality of life and extend survival duration.
Currently, there is limited multi-center data on therapeutic endoscopy clinical outcomes and standardized treatment algorithms in western populations. Due to continuing variations in therapeutic EUS procedures, as well as introduction of some TEUS procedure accessories; it is necessary to periodically evaluate the efficacy and safety of specific TEUS procedures and accessories for several indications to check for improved clinical outcomes.
Evaluation of these clinical details would help us compare them to conventional treatment modalities within our current facility and scope of practice; and consequently, help us identify safe and cost-effective treatment techniques, develop treatment algorithms and improve clinical management of patients at RWJMS and other tertiary-care centers.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects undergoing Therapeutic Endoscopic Ultrasound | – | Procedure: Therapeutic Endoscopic UltrasoundProcedures that will be captured include: EUS- ERCP, Endoscopic Hepatology - EUS, EUS-Coils placement, EUS Glue injection, EUS-Fiducial placement, EUS-Neurolysis, EUS-Stent placement, EUS-alcohol injection, EUS-guided Ablation, EUS-guided anastomosis, EUS Guided ERCP for gallbladder, pancreatic duct or biliary duct drainage, EUS guided - Hemostasis, EUS guided- Therapy for cancer or premalignant lesion (Injection, neurolysis, fiducial, aspiration, RFA ), EUS - Fluid Collection, abscess or cavity drainage, EUS - Guided Ductal Drainage, EUS - Guided Anastomosis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects undergoing Interventional Therapeutic Endoscopic Ultrasound Procedures for Gastrointestinal indications
Key inclusion criteria (1 listed)
- Subjects undergoing Interventional Therapeutic Endoscopic Ultrasound Procedures for Gastrointestinal indications
Key exclusion criteria (1 listed)
- Subjects not undergoing Interventional Therapeutic Endoscopic Ultrasound Procedures for Gastrointestinal indications
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 Endoscopic UltrasoundTherapeutic Endoscopic Ultrasound or Interventional Endoscopy for Gastrointestinal Indications | Procedure or surgery | Subjects undergoing Therapeutic Endoscopic Ultrasound |
Primary outcome
Efficacy of Procedure
Time frame: Upto 2 years
Technical and clinical success rates
Safety of procedure
Time frame: Upto 2 years
Type, frequency and intensity of adverse events
1 secondary outcome
Cost Effectiveness
Time frame: Upto 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- Derived from this study: PubMed 38713274Karanfilian B, Tyberg A, Sarkar A, Shahid HM, Simon A, Reinoso K, Bapaye A, Gandhi A, Gadhikar HP, Dorwat S, Raina H, Ansari J, Nieto J, Qadir N, Porfilio MG, Arevalo-Mora M, Puga-Tejada M, Alcivar-Vasquez J, Robles-Medranda C, Ardengh JC, Bareket R, Liao K, Patel R, Pimpinelli S, Gaidhane M, Kahaleh M. Impact of COVID-19 Infection on Pancreato-Biliary Diseases Requiring Endoscopic Retrograde Cholangiopancreatography. Dig Dis Sci. 2024 Aug;69(8):3015-3018. doi: 10.1007/s10620-024-08454-1. Epub 2024 May 7.
- Derived from this study: PubMed 37141073Tyberg A, Duarte-Chavez R, Shahid HM, Sarkar A, Simon A, Shah-Khan SM, Gaidhane M, Mohammad TF, Nosher J, Wise SS, Needham V, Kheng M, Lajin M, Sojitra B, Wey B, Dorwat S, Raina H, Ansari J, Gandhi A, Bapaye A, Shah-Khan SM, Krafft MR, Thakkar S, Singh S, Bane JR, Nasr JY, Lee DP, Kedia P, Arevalo-Mora M, Del Valle RS, Robles-Medranda C, Puga-Tejada M, Vanella G, Ardengh JC, Bilal M, Giuseppe D, Arcidiacono PG, Kahaleh M. Endoscopic Ultrasound-Guided Gallbladder Drainage Versus Percutaneous Drainage in Patients With Acute Cholecystitis Undergoing Elective Cholecystectomy. Clin Transl Gastroenterol. 2023 Jun 1;14(6):e00593. doi: 10.14309/ctg.0000000000000593.
- Derived from this study: PubMed 36730114Tyberg A, Sarkar A, Shahid HM, Shah-Khan SM, Gaidhane M, Simon A, Eisenberg IA, Lajin M, Karagyozov P, Liao K, Patel R, Zhao E, Martinez MG, Artifon EL, Lino AD, Vanella G, Arcidiacono PG, Kahaleh M. EUS-Guided Biliary Drainage Versus ERCP in Malignant Biliary Obstruction Before Hepatobiliary Surgery: An International Multicenter Comparative Study. J Clin Gastroenterol. 2023 Oct 1;57(9):962-966. doi: 10.1097/MCG.0000000000001795.
- Individual participant dataSharing planned: No. Data will not be made available to other out-of-site researchers
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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. This study is not recruiting at the moment.
Michel Kahaleh, MD principal investigator
Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University
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 Therapeutic Endoscopic Ultrasound and Advanced Endoscopy, run by Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University at 1 site in United States.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 May 2023. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Procedure (time frame: Upto 2 years). The study lists 2 primary outcomes in all. 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 NCT05051358, which also lists 3 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 26 May 2023.