UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021200 |
|---|---|
| Receipt number | R000024449 |
| Scientific Title | Phase II trial of feasibility of efficacy and safety of laparoscopy endoscopy hybrid surgery for low malignant tumor of duodenum |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2019/02/25 14:10:58 |
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Basic information
Public title
Phase II trial of feasibility of efficacy and safety of laparoscopy endoscopy hybrid surgery for low malignant tumor of duodenum
Acronym
Phase II trial of feasibility of efficacy and safety of laparoscopy endoscopy hybrid surgery for low malignant tumor of duodenum
Scientific Title
Phase II trial of feasibility of efficacy and safety of laparoscopy endoscopy hybrid surgery for low malignant tumor of duodenum
Scientific Title:Acronym
Phase II trial of feasibility of efficacy and safety of laparoscopy endoscopy hybrid surgery for low malignant tumor of duodenum
Region
| Japan |
Condition
Condition
Duodenal adenoma, duodenal mucosal cancer, duodenal NET, duodenal SMT
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of in laparoscopy endoscopy hybrid surgery for low malignant tumor of duodenum
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Postoperative one-week complication rates in laparoscopy endoscopy hybrid surgery
Key secondary outcomes
Surgical process (operative time, intraoperative bleeding, the number of ports, the use of the saturation, cost, the rates of laparotomy transition), postoperative course (oral intake, length of stay, inflammatory findings, the rates of late complications, stenosis).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Hybrid endoscopic and laparoscopic partial duodenectomy for low malignant tumor of duodenum.
Closing the site of duodenectomy by laparoscopic hand-sewn saturation.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Duodenal adenoma, duodenal mucosal cancer (adenocarcinoma), duodenal NET (less than 20 mm, longer axis), duodenal SMT (less than 50 mm, longer axis)
2)Intraluminal developmental form of SMT
3)Performance status o and 1
4)Plt => 100,000/mm3
Creatinine <= 2.0 mg/dl
AST <= 200 IU/L
ALT <= 200 IU/L
T-bil <= 2.0 mg/dl
Hb => 8.0 g/dl
5)Patients who gave written informed consent before entry in this study
Key exclusion criteria
1)Ischemic heart disease
2)Liver cirrhosis, active hepatitis
3)Interstitial pneumonia
4)Haemodialysis
5)Both malignant disorder
6)Severe abdominal adhesion
7)Doctor's decision not to register to this regimen
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiyasu Ojima |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
Address
Kimiidera 811-1, Wakayama, Japan
TEL
073-441-0613
tojima@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiyasu Ojima |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
Address
Kimiidera 811-1, Wakayama, Japan
TEL
073-441-0613
Homepage URL
tojima@wakayama-med.ac.jp
Sponsor or person
Institute
Second Department of Surgery, Wakayama Medical University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Second Department of Surgery, Wakayama Medical University, School of Medicine
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
Address
Tel
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
和歌山県立医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/29352442
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
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 25 | Day |
Last modified on
| 2019 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024449
