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Duodenal Gel-immersion Endoscopic submucosal dissection for Large superficial non-ampullary duodenal epithelial lesions (D-GEL study)

Duodenal Gel-immersion Endoscopic submucosal dissection for Large superficial non-ampullary duodenal epithelial lesions (D-GEL study) - Duodenal Gel-immersion Endoscopic submucosal dissection for Large superficial non-ampullary duodenal epithelial lesions (D-GEL study)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000061003
Enrollment
160
Registered
2026-05-01
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Superficial non-ampullary duodenal epithelial tumor

Interventions

None listed

Sponsors

Kyoto Prefectural University of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients have a lesion diagnosed as SNADET by endoscopic examination, including suspected cases, regardless of whether a biopsy has been performed, and are scheduled to undergo ESD. 2. The lesion is 20 mm or larger in size based on the preoperative endoscopic diagnosis. 3. Saline- or Gel-immersion observation has been performed during the preoperative endoscopic examination, and the lesion has been judged to be appropriate for treatment under gel immersion. 4. The patient is aged 20 years or older and younger than 90 years at the time of enrollment. 5. The patient has received a full explanation regarding participation in the study, and written informed consent has been obtained from the patient.

Exclusion criteria

Exclusion criteria: 1. Lesions larger than 50 mm. 2. Lesions in which the resection area involves the pyloric ring or the major papilla. 3. Patients with a history of gastric or duodenal surgery. 4. Cases in which follow-up until 14 days after ESD is not feasible. 5. Cases considered inappropriate for study participation by the investigator.

Design outcomes

Primary

MeasureTime frame
Intraoperative perforation rate

Countries

Japan

Contacts

Public ContactOsamu Dohi

University hospital of Kyoto Prefectural University of Medicine Department of Gastroenterology and Hepatology

osamu-d@koto.kpu-m.ac.jp075-251-5519

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026