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Randomized controlled trial on the feasibility and safety of "Underwater endoscopic mucosal resection with injection" versus "conventional endoscopic mucosal resection" for superficial nonampullary duodenal epithelial tumors

Randomized controlled trial on the feasibility and safety of "Underwater endoscopic mucosal resection with injection" versus "conventional endoscopic mucosal resection" for superficial nonampullary duodenal epithelial tumors - UEMRI vs CEMR study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000041265
Enrollment
208
Registered
2020-08-01
Start date
2021-01-12
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Superficial nonampullary duodenal epithelial tumor

Interventions

Underwater EMR with injection (UEMRI) group
after dotted marking, a small amount of saline is injected to submucosal layer. The lumen is deflated and filled with saline. The floating lesion is grasped and resected with a electrosurgical snare.
after dotted marking, saline is injected submucosal layer. The lesion is grasped and resected with a electrosurgical snare. After confirming that there are no bleeding, perforation and residual lesion

Sponsors

Nagasaki University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Superficial nonampullary duodenal epithelial tumors with a size between 5 mm to 20 mm. 2) Adenoma or intramucosal cancer

Exclusion criteria

Exclusion criteria: 1) Lesions near the papillae 2) Suspect of submucosal invasive cancer 3) Residual lesions after endoscopic resection 4) Patients related with FAP or Lynch syndrome 5) Patients with hematological abnormality 6) Patients with severe organ failure 7) Patients who have been judged as inappropriate for this study

Design outcomes

Primary

MeasureTime frame
R0 resection rate

Secondary

MeasureTime frame
En bloc resection rate Remnant/recurrence rate at 6 months later after procedure Procedure time Total procedure time Adverse events rate

Countries

Japan

Contacts

Public ContactKeiichi Hashiguchi

Nagasaki Unicersity Hospital Department of Endoscopy

khashiguchi@nagasaki-u.ac.jp095-819-7489

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026