UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026726 |
|---|---|
| Receipt number | R000030683 |
| Scientific Title | Feasibility study of the LECS(Laparoscopy and Endoscopy Cooperative Surgery) to the non-ampullary duodenal tumor. |
| Date of disclosure of the study information | 2017/06/01 |
| Last modified on | 2021/09/29 20:53:06 |
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Basic information
Public title
Feasibility study of the LECS(Laparoscopy and Endoscopy Cooperative Surgery) to the non-ampullary duodenal tumor.
Acronym
LECS to the non-amupullary duodenal tumor
Scientific Title
Feasibility study of the LECS(Laparoscopy and Endoscopy Cooperative Surgery) to the non-ampullary duodenal tumor.
Scientific Title:Acronym
LECS to the non-amupullary duodenal tumor
Region
| Japan |
Condition
Condition
non-ampullary duodenal tumor
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We assume LECS to the non-amupurally tumor is safe and effective procedure. This study aimed the verification of this.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Phase I
Assessment
Primary outcomes
Complication rate(post operative bleeding,dysraphia,abscess,digestive tract disoder,re-operation rate)
Key secondary outcomes
Operation time, hospitalization, pathological assessment of resected lesion
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
LECS to the non-ampullary tumor
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
non-amupullary adenoma or mucosal cancer, Neuroendocrine tumor, GIST
1.Satisfy the either of the following conditions Adenoma or adenoarcinoma
2.Tumor size 20-35mm
3.Impossible to perform endoscopic resection due to the ulceration scar
4.If cancer, limited to mucosal cancer
GIST or NET
1.Adaptation to perform partial resection
Key exclusion criteria
1.Advanced cancer
2.need systematic therapy of infeciton
3.need systematic therapy of anti-cancer drug.
4.need systematic thrapy of steroid
5.pregnancy or lacting
6.no more than 3 year prognosis
7.the physician judges to be inappropriate
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Okada |
Organization
Okayama University hospital
Division name
Department of gastroenterology
Zip code
700-8558
Address
2-5-1, shikata-cho, kita-ku, okayama
TEL
086-235-7219
hiro@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiromitsu |
| Middle name | |
| Last name | Kanzaki |
Organization
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name
Gastroenterology and Hepatology
Zip code
700-8558
Address
2-5-1, shikata-cho, kita-ku, okayama
TEL
086-235-7219
Homepage URL
kanzaki@qc4.so-net.ne.jp
Sponsor or person
Institute
Okayama University hospital, department of gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Okayama University hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1, shikata-cho, kita-ku, okayama
Tel
086-235-6938
mae6605@adm.okayama-u.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
| 2017 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
in the process of publication
Publication of results
Unpublished
Result
URL related to results and publications
in the process of publication
Number of participants that the trial has enrolled
7
Results
The operative time was 269 (164-420) min, the blood loss was 0 (0-75) ml, and there were two cases of microperforation during the endoscopic procedure, but there was no problem in continuing the treatment. 6 cases were resected en bloc, and one case was resected in sections. Postoperative complications (C-D over 2) were observed in two patients, one with paralytic ileus and one with delayed gastric emptying, and postoperative hospital stay was 12.5 (9-22) days.
Results date posted
| 2021 | Year | 04 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Tumor localization was bulbs in 1 case, descending in 4 cases, and horizontal in 2 cases. The median tumor diameter was 30 mm (12-35), with 2 cases of elevated type, 3 cases of superficial elevated type, and 2 cases of superficial depressed type. All cases were biopsied preoperatively and were adenomas.
Participant flow
Seven cases were informed and all cases participated.
Adverse events
Postoperative complications (C-D over 2) were observed in two patients, one with paralytic ileus and one with delayed gastric emptying
Outcome measures
Safe and effective in all cases
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2021 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 27 | Day |
Last modified on
| 2021 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030683
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