Clinical trial · Observational
T-EUS for Gastrointestinal Disorders: A Multicenter Registry
Therapeutic Endoscopic Ultrasound (T-EUS) Guided Procedures in the Management of Gastrointestinal Disorders: A Multicenter Registry.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this registry is to record information and evaluate the impact of Endoscopic Ultrasound (EUS) Guided Endoscopic retrograde cholangiopancreatography (ERCP) on the management of pancreatico-biliary disorders. The registry will evaluate efficacy, safety and technical success of the Endoscopic Ultrasound (EUS)Guided Endoscopic retrograde cholangiopancreatography (ERCP) procedures. The safety and efficacy of various EUS-Guided ERCP procedures have been assessed in a series of studies. This multi-center registry has been initiated: * To document the impact of EUS-Guided ERCP procedures on the management of pancreatico-biliary disorders including malignancies. * To assess the clinical and technical success rates of EUS-Guided ERCPs for diagnostic or therapeutic procedures. Design is retrospective and prospective registry study. Procedures that will be captured include: 1. EUS-Coils placement 2. EUS Glue injection 3. EUS-Fiducial placement 4. EUS-Neurolysis 5. EUS-Stent placement 6. EUS-alcohol injection 7. EUS-fluid collection, abscess or cavity drainage 8. EUS guided ductal drainage 9. EUS-guided Ablation 10. EUS-guided anastomosis 11. EUS Guided ERCP for gallbladder, pancreatic duct or biliary duct drainage
Conditions
Conditions (14)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Altered Anatomy | — | UNRESOLVED | — |
| Ampullary Cancer | Ampulla of Vater Carcinoma | ALIAS | 0.90 |
| Bile Duct Cancer | Malignant Bile Duct Neoplasm | CURATED_BROADER | 0.80 |
| Biliary Obstruction | — | UNRESOLVED | — |
| Biliary Sphincter Stenosis | — | UNRESOLVED | — |
| Biliary Stricture | — | UNRESOLVED | — |
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Chronic Pancreatitis | — | UNRESOLVED | — |
| Distal Duct Stricture |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EUS guided ERCP | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- EUS guided ERCP procedure group
- description
- Subjects who will undergo Endoscopic Ultrasound (EUS) guided Endoscopic retrograde cholangiopancreatography (ERCP) procedures for their pancreatico-biliary conditions.
- interventionNames
- Procedure: EUS guided ERCP
Primary outcomes (1)
- measure
- Safety
- timeFrame
- 3 years
- description
- Documentation of Safety- Number of Participants with Adverse Events; Type, frequency and intensity of adverse events
Secondary outcomes (2)
- measure
- Efficacy
- timeFrame
- 3 years
- description
- Documentation of efficacy: Technical and clinical success rates. * Technical Success rate will be derived from reported success or failure of technical feasibility and conduction of a specific EUS Guided ERCP procedure for a pancreatico-biliary condition. * Clinical success rate will be derived from reported of clinical success hallmarks such as biliary or pancreatic drainage, reduction in total bilirubin, formation of a fistula, immediate and eventual alleviation of symptoms or complaints within a specific period of time, etc. for that particular pancreatico-biliary disorder.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Any patient who has undergone EUS-guided ERCP (Endoscopic Retrograde Cholangiopancreatography)for diagnosis or treatment of a pancreatico-biliary disorder. * Above 18 years of age. Exclusion Criteria: * Any subject who has not undergone Endoscopic Ultrasound (EUS) guided Endoscopic retrograde cholangiopancreatography (ERCP). * Below 18 years of age.
References
Publications (7)
- DERIVEDTyberg A, Kats D, Choi A, Gaidhane M, Nieto J, Kahaleh M. Endoscopic Ultrasound Guided Gastroenterostomy: What Is the Learning Curve? J Clin Gastroenterol. 2021 Sep 1;55(8):691-693. doi: 10.1097/MCG.0000000000001400. PMID 32740096
- DERIVEDKumta NA, Tyberg A, Bhagat VH, Siddiqui AA, Kowalski TE, Loren DE, Desai AP, Sarkisian AM, Brown EG, Karia K, Gaidhane M, Kedia P, Tarnasky PR, Patel U, Adler D, Taylor LJ, Petrone M, Arcidiacono P, Yachimski PS, Weine D, Sundararajan S, Deprez PH, Mouradides C, Ho S, Javed S, Easler JJ, Raijman I, Vazquez-Sequeiros E, Sawhney M, Berzin TM, Kahaleh M. EUS-guided drainage of pancreatic fluid collections using lumen apposing metal stents: An international, multicenter experience. Dig Liver Dis. 2019 Nov;51(11):1557-1561. doi: 10.1016/j.dld.2019.05.033. Epub 2019 Jul 2. PMID 31272934
- DERIVEDSiddiqui A, Kunda R, Tyberg A, Arain MA, Noor A, Mumtaz T, Iqbal U, Loren DE, Kowalski TE, Adler DG, Saumoy M, Gaidhane M, Mallery S, Christiansen EM, Nieto J, Kahaleh M. Three-way comparative study of endoscopic ultrasound-guided transmural gallbladder drainage using lumen-apposing metal stents versus endoscopic transpapillary drainage versus percutaneous cholecystostomy for gallbladder drainage in high-risk surgical patients with acute cholecystitis: clinical outcomes and success in an International, Multicenter Study. Surg Endosc. 2019 Apr;33(4):1260-1270. doi: 10.1007/s00464-018-6406-7. Epub 2018 Sep 12. PMID 30209610
- DERIVEDTyberg A, Sharaiha RZ, Kedia P, Kumta N, Gaidhane M, Artifon E, Giovannini M, Kahaleh M. EUS-guided pancreatic drainage for pancreatic strictures after failed ERCP: a multicenter international collaborative study. Gastrointest Endosc. 2017 Jan;85(1):164-169. doi: 10.1016/j.gie.2016.07.030. Epub 2016 Jul 25. PMID 27460387
- DERIVEDKahaleh M, Perez-Miranda M, Artifon EL, Sharaiha RZ, Kedia P, Penas I, De la Serna C, Kumta NA, Marson F, Gaidhane M, Boumitri C, Parra V, Rondon Clavo CM, Giovannini M. International collaborative study on EUS-guided gallbladder drainage: Are we ready for prime time? Dig Liver Dis. 2016 Sep;48(9):1054-7. doi: 10.1016/j.dld.2016.05.021. Epub 2016 Jun 3.