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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000019410
Receipt No. R000022447
Scientific Title Evaluation of safety and efficacy of laparoscopic and endoscopic cooperative surgery (LECS) for duodenal tumor
Date of disclosure of the study information 2015/11/20
Last modified on 2016/03/02

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Basic information
Public title Evaluation of safety and efficacy of laparoscopic and endoscopic cooperative surgery (LECS) for duodenal tumor
Acronym Evaluation of safety and efficacy of LECS for duodenal tumor
Scientific Title Evaluation of safety and efficacy of laparoscopic and endoscopic cooperative surgery (LECS) for duodenal tumor
Scientific Title:Acronym Evaluation of safety and efficacy of LECS for duodenal tumor
Region
Japan

Condition
Condition duodenal adenoma, eraly duodenal cancer, duodenal GIST, duodenal carcinoid
Classification by specialty
Medicine in general Gastroenterology Surgery in general
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of safety in laparoscopic and endoscopic cooperative surgery (LECS) for duodenal tumor
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Evaluation of postoperative complication rates in LECS, in comparison with previous reported complication rates following simple endoscopic resection in duodenal tumor
Key secondary outcomes Evaluation of pancereatoduodenectomy (PD) rates due to postoperative complications following LECS, in comparison with previous reported PD rates due to complications following simple endoscopic resection in duodenal tumor

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 Inclusion criteria
1. Preoperative diagnosis is confirmed as a duodenal adenoma, early duodenal cancer, duodenal GIST and duodenal carcinoid.
2. Tumors located from bulbs to lower portion of duodenum
3. Age of more than 20 years old at
4. Performance status 0, 1 and 2
5. Fulfill all below criterion
Hb =>9 g/dl
Plt=>100,000/mm3
AST or ALT <=100 lU/l
Serum creatinine<=2.0 mg/dl
PT-INR% =>80%
6. Patients who could be followed during 56 days
7. Patients who agree the content of this study

Key exclusion criteria Exclusion criteria
1. Patients who could not agree the content of this study.
2. Residual tumor following endoscopic resection
3. Totally of sub circumferential tumor
4. Tumors located in Ampulla of Vater
5. Tumors which the surface is near the pancreas
6. Post radiation therapy
7. Severe abdominal adhesion
8. Patients who are pregnant
9. Patients who have a psychiatric disorder
10. Patients who have active infectious or fungal disease
11. Severe hypertension
12. Severe respiratory disease
13. Patients that researchers admit inadequate for candidates
Target sample size 20

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Eigo Otsuji
Organization Kyoto Prefectural University of Medicine
Division name Division of Digestive Surgery, Department of Surgery
Zip code
Address Kyoto Prefectural University of Medicine, 465 Kawaramachi-hirokoji, Kamigyo-ku, Kyoto, 602-8566, Japan
TEL (+81)75-251-5527
Email otsuji@koto.kpu-m.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Shuhei Komatsu
Organization Kyoto Prefectural University of Medicine
Division name Division of Digestive Surgery, Department of Surgery
Zip code
Address Kyoto Prefectural University of Medicine, 465 Kawaramachi-hirokoji, Kamigyo-ku, Kyoto, 602-8566, Jap
TEL (+81)75-251-5527
Homepage URL
Email skomatsu@koto.kpu-m.ac.jp

Sponsor
Institute Division of Digestive Surgery, Department of Surgery, Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Digestive Surgery Donation 1
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
Email

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
2015 Year 11 Month 20 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 Enrolling by invitation
Date of protocol fixation
2015 Year 11 Month 10 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information As a recruiting method of patients, we will recruit all patients who meet our study criteria since November 20, 2015.

Management information
Registered date
2015 Year 10 Month 19 Day
Last modified on
2016 Year 03 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022447

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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