UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036973 |
|---|---|
| Receipt number | R000041642 |
| Scientific Title | Prospective cohort study of duodenal laparoscopy-endoscopy cooperative surgery for non-ampullary duodenal tumor |
| Date of disclosure of the study information | 2019/06/05 |
| Last modified on | 2026/06/09 12:33:50 |
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Basic information
Public title
Prospective cohort study of duodenal laparoscopy-endoscopy cooperative surgery for non-ampullary duodenal tumor
Acronym
Prospective study of D-LECS
Scientific Title
Prospective cohort study of duodenal laparoscopy-endoscopy cooperative surgery for non-ampullary duodenal tumor
Scientific Title:Acronym
D-LECS study
Region
| Japan |
Condition
Condition
superficial non-ampullary duodenal tumor, non-ampullary duodenal submuocsal tumor
Classification by specialty
| Hepato-biliary-pancreatic medicine | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Assessment of duodenal laparoscopy-endoscopy cooperative surgery (LECS) for non-ampullary duodenal tumor
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Success rate of treatment
Key secondary outcomes
Adverse event, Treatment time, Hospital stay, Recurrence rate
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1-1. Superficial non-ampullary duodenal tumor (SNADET) larger than 2cm in size
1-2. SNADET that will not be able to closepost-ESD ulcer
1-3. Duodenal submucosal tumor (SMT) without ulcer larger than 1cm
2. Age older than 20 years
Key exclusion criteria
1. Duodenal tumor that can not be cured with local resection
2. Duodenal ampullary tumor
3. Contraindication for laparoscopic surgery
4. Contraindication for general anethesia, including severe heart and lung failure.
5. A paient without consent
6. Inappropriate case by physician's judgement
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiromi |
| Middle name | |
| Last name | Kataoka |
Organization
Nagoya City University Hospital
Division name
Department of Gastroenterology
Zip code
467-8601
Address
Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
TEL
052-853-8211
hkataoka@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Takaya |
| Middle name | |
| Last name | Shimura |
Organization
Nagoya City University Hospital
Division name
Department of Gastroenterology
Zip code
467-8601
Address
Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
TEL
052-853-8211
Homepage URL
tshimura@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Department of Gastroenterology,
Department of Surgery,
Nagoya City University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Clinical Research Management Center, Nagoya City University Hospital
Address
Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya 467-8602, Japan
Tel
052-851-5511
clinical_research@med.nagoya-cu.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
名古屋市立大学病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 06 | Month | 05 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S1590865825010746?via%3Dihub
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S1590865825010746?via%3Dihub
Number of participants that the trial has enrolled
20
Results
The median treatment time was 296 min for total D-LECS and 115 min for ESD. The clinical success rate was 100%, with 100% en bloc resection, 80% R0 resection, and no recurrence.
Results date posted
| 2026 | Year | 06 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 11 | Month | 01 | Day |
Baseline Characteristics
The median tumor size was 30 mm. The tumor locations were as follows: 7 cases in the proximal descending part, 9 cases in the distal descending part, and 4 cases in the transverse part. The breakdown of the postoperative pathological diagnoses for the 20 cases was as follows: VCL Category 3: 6 cases; VCL Category 4/5: 12 cases; NET: 1 case; and lipoma: 1 case.
Participant flow
This study is a single-center, prospective observational study. Between August 2019 and December 2023, 20 patients with superficial nonampullary duodenal tumors located in the descending and horizontal duodenum, in whom endoscopic suturing following ESD was anticipated to be difficult, were prospectively enrolled and underwent D-LECS.
Adverse events
ntraoperative perforations were observed in three cases; however, in all cases, complete closure was promptly achieved via laparoscopic seromuscular suturing following the planned ESD. No cases of postoperative perforation, postoperative bleeding, or postoperative pancreatitis were observed.
Outcome measures
The primary endpoint was clinical success rate, which was 100 %.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 04 | Month | 19 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 04 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 05 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2019 | Year | 06 | Month | 05 | Day |
Last modified on
| 2026 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041642
