# EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction (CARPEDIEM Trial)

> **NCT06653192** · NA · SUSPENDED · sponsor: **Hospital Universitari de Bellvitge** · enrollment: 120 (estimated)

## Conditions studied

- Malignant Biliary Obstruction
- Pancreatic Cancer
- Biliary Tract Neoplasms

## Interventions

- **PROCEDURE:** Endoscopic biliary drainage
- **DEVICE:** Self-expandable metallic stent (SEMS)
- **DEVICE:** Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS)

## Key facts

- **NCT ID:** NCT06653192
- **Lead sponsor:** Hospital Universitari de Bellvitge
- **Sponsor class:** OTHER
- **Phase:** NA
- **Study type:** INTERVENTIONAL
- **Status:** SUSPENDED
- **Start date:** 2025-05-06
- **Primary completion:** 2027-06-06
- **Final completion:** 2028-05-06
- **Target enrollment:** 120 (ESTIMATED)
- **Why stopped:** Class I Recall (Feb 2026): Boston Scientific issued a global recall for specific lots of AXIOS 6x8mm and 8x8mm due to reports of deployment and expansion failure during the procedure.
- **Last updated:** 2026-05-06

## Collaborators

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## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06653192

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06653192, "EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction (CARPEDIEM Trial)". Retrieved via AI Analytics 2026-06-13 from https://api.ai-analytics.org/clinical/NCT06653192. Licensed CC0.

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