UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061003 |
|---|---|
| Receipt number | R000069808 |
| Scientific Title | Duodenal Gel-immersion Endoscopic submucosal dissection for Large superficial non-ampullary duodenal epithelial lesions (D-GEL study) |
| Date of disclosure of the study information | 2026/05/01 |
| Last modified on | 2026/03/21 16:12:17 |
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Basic information
Public title
Duodenal Gel-immersion Endoscopic submucosal dissection for Large superficial non-ampullary duodenal epithelial lesions (D-GEL study)
Acronym
Duodenal Gel-immersion Endoscopic submucosal dissection for Large superficial non-ampullary duodenal epithelial lesions (D-GEL study)
Scientific Title
Duodenal Gel-immersion Endoscopic submucosal dissection for Large superficial non-ampullary duodenal epithelial lesions (D-GEL study)
Scientific Title:Acronym
Duodenal Gel-immersion Endoscopic submucosal dissection for Large superficial non-ampullary duodenal epithelial lesions (D-GEL study)
Region
| Japan |
Condition
Condition
Superficial non-ampullary duodenal epithelial tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To identify the safety and efficacy of gel immersion ESD for SNADET
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intraoperative perforation rate
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key 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.
Key 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.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Dohi |
Organization
University hospital of Kyoto Prefectural University of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
602-8566
Address
465, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
TEL
075-251-5519
osamu-d@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Osamu |
| Middle name | |
| Last name | Dohi |
Organization
University hospital of Kyoto Prefectural University of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
602-8566
Address
465, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
TEL
075-251-5519
Homepage URL
osamu-d@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Selfish
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee of Kyoto Prefectural University of Medicine
Address
465, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
Tel
075-251-5337
rinri@koto.kpu-m.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study is to prospectively evaluate the efficacy and safety of gel-immersion endoscopic submucosal dissection (GI-ESD) for large superficial non-ampullary duodenal epithelial tumors (SNADETs) and to clarify the clinical feasibility of this technique. Patients will be prospectively enrolled. After complete deflation of the duodenal lumen, GI-ESD will be performed iusing endoscopic gel (Viscoclear) to achieve en bloc resection of the lesion. Based on the collected data, the en bloc resection rate, adverse events, R0 resection rate, procedure time, intraoperative perforation rate, and delayed bleeding rate will be assessed to determine the efficacy and safety of gel-immersion ESD.
Management information
Registered date
| 2026 | Year | 03 | Month | 21 | Day |
Last modified on
| 2026 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069808
