Prospective observational study to verify the safety of endoscopic radiofrequency ablation for the recurrence of endoscopic submucosal dissection (ESD) duodenal tumors including papilla (ESDIP: ESD including papilla)

Prospective observational study to verify the safety of endoscopic radiofrequency ablation for the recurrence of endoscopic submucosal dissection (ESD) duodenal tumors including papilla (ESDIP: ESD including papilla) - Prospective observational study to verify the safety of endoscopic radiofrequency ablation for the recurrence of endoscopic submucosal dissection (ESD) duodenal tumors including papilla (ESDIP: ESD including papilla)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000057348

Enrollment

Registered

2025-03-19

Start date

2025-02-14

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

duodenam tumor

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients planning to undergo endoscopic radiofrequency ablation for duodenum recurrence after ESDIP. 2. Preoperative diagnosis of less than 20mm duodenum tumor invasion to bile duct 3. Patients aged between 20 and 85 years at the time of consent 4. Patients who give written consent to participate in this study

Exclusion criteria

Exclusion criteria: 1.multiple cholangio tumor 2.surgical tolerant patients with invasive duodenum cancer 3. A case that the attending physician determines that patient is not suitable for this study 4. A case that patient refuses to participate in this study after enrollment.

Design outcomes

Primary

Measure	Time frame
the complication rate more than IIIb of Clavien-Dindo classification	—

Secondary

Measure	Time frame
incidence of intra-operative adverse events, incidence of post-operative adverse events.	—

Countries

Japan

Contacts

Public ContactShintaro Kawasaki

Keio University School of Medicine Center for Diagnostic and Therapeutic Endoscopy

s.kawasaki@keio.jp03-3353-1211

Outcome results