Last reviewed · How we verify
NCT04595058: BAMPI
LAMS Choledochoduodenostomies: With or Without Coaxial Plastic Stent
NA trial testing Double pigtail plastic stent through lumen-apposing metal stent in Biliary Obstruction in 123 participants. Completed in 17 October 2023.
17 October 2022
Quick facts
| Lead sponsor | Hospital Universitari de Bellvitge |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 123 |
| Start date | 17 November 2020 |
| Primary completion | 17 October 2022 |
| Estimated completion | 17 October 2023 |
| Sites | 2 locations across Spain |
Drugs / interventions tested
- Double pigtail plastic stent through lumen-apposing metal stent
- Lumen-apposing metal stent without double pigtail plastic stent
Conditions studied
- Biliary Obstruction — all drugs for Biliary Obstruction →
- Pancreatic Cancer — all drugs for Pancreatic Cancer →
- Biliary Tract Neoplasms — all drugs for Biliary Tract Neoplasms →
Sponsor
Hospital Universitari de Bellvitge
Who can join
18 and older, any sex, with Biliary Obstruction or Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of the study is to evaluate technical, clinical and safety outcomes of lumen-apposing metal stent (LAMS) with and without a coaxial double-pigtail plastic stent (DPS) in EUS-guided choledochoduodenostomies (CDS) for the management of biliary obstruction.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
Multicenter study of lumen-apposing metal stents with or without pigtail in endoscopic ultrasound-guided biliary drainage for malignant obstruction-BAMPI TRIAL: an open-label, randomized controlled trial protocol.
Garcia-Sumalla A, Loras C, Sanchiz V, Sanz RP, et al · · 2022 · cited 26× · PMID 35216619 · DOI 10.1186/s13063-022-06106-1 -
Lumen-Apposing Stents With or Without Pigtail in Endosonography-Guided Biliary Drainage for Malignant Distal Biliary Obstruction.
Sumalla-Garcia A, Aparicio-Tormo JR, Pedraza-Sanz R, Sanchiz-Soler V, et al · · 2026 · cited 2× · PMID 40701486 · DOI 10.1016/j.cgh.2025.05.025 -
Advances in Endoscopic Management of Distal Biliary Stricture: Integrating Clinical Evidence into Patient-Specific Decision-Making.
Yamada R, Miwata T, Nakamura Y, Nose K, et al · · 2025 · cited 1× · PMID 40867273 · DOI 10.3390/cancers17162644 -
Specialized coaxial hepaticogastrostomy stent and lumen-apposing stent for salvage of dysfunctional EUS-guided cholecochoduodenostomy.
Garcia-Sumalla A, Quintana-Carbo S, Gornals JB. · · 2023 · cited 1× · PMID 37040882 · DOI 10.1055/a-2055-1200 -
UEG Week 2023 Moderated Posters
· 2023 -
Conversion of a dysfunctional choledochoduodenostomy to transpapillary drainage via a trans-lumen-apposing metal stent choledochoduodenoscopy.
Gornals JB, Garcia-Sumalla A, Puigcerver-Mas M. · · 2023 · PMID 37719953 · DOI 10.1016/j.vgie.2023.05.016 -
Multicenter Study of Lumen-apposing Metal Stents With or Without Pigtail in Endoscopic Ultrasound-guided Biliary Drainage for Malignant Obstruction- Bampi Trial: an Open-label, Randomized Controlled Trial Protocol.
Garcia-Sumalla A, Loras C, Sanchiz V, Pedraza-Sanz R, et al · · 2022 · DOI 10.21203/rs.3.rs-1286894/v1
Verify or expand the search:
- PubMed search for NCT04595058
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Biliary Obstruction
Currently open trials in the same condition.
- NCT06620328 — Safety and Efficacy of Mechanical Versus Electrocautery Dilator for EUS-guided Biliary Drainage (MED-BD) · NA · recruiting
- NCT07407491 — Comparative Efficacy Of Intraductal Antibiotic During ERCP In Acute Cholangitis · Phase 2 · recruiting
- NCT06287112 — Prevention of Acute Cholecystitis With ETGBD · NA · recruiting
- NCT04857424 — Quality of Life Assessment Between Internal Endoscopic Versus Percutaneous Drainage in Biliary Obstruction · active not recruiting
- NCT04813055 — Prospective Registry Of Therapeutic EndoscopiC ulTrasound · recruiting
Other Hospital Universitari de Bellvitge trials
Trials by the same sponsor.
- NCT07522931 — Morphometric Study of the Female Pelvic and Lower Abdominal Retroperitoneum in Cadavers · recruiting
- NCT07155590 — Subphenotype- and Complication-guided Adjunctive Fosfomycin Therapy for Staphylococcus Aureus Bacteraemia · active not recruiting
- NCT06653192 — EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction (CARPEDIEM Trial) · NA · recruiting
- NCT07178483 — Evaluation of Physical Capacity and Energy Requirements in Patients With Hypoxemic Acute Respiratory Failure · active not recruiting
- NCT06955221 — Effect of Alcohol Sclerotherapy on Pelvic Pain and Quality of Life in Women With Ovarian Endometriosis · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04595058 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospital Universitari de Bellvitge
- Last refreshed: 18 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04595058.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing