UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011081 |
|---|---|
| Receipt number | R000012956 |
| Scientific Title | Surgical stress, cardiopulmonary and immunologic effect of hybrid natural orfice transluminal endoscopic surgery (NOTES) compared to laparoscopic surgery |
| Date of disclosure of the study information | 2013/07/01 |
| Last modified on | 2015/08/03 17:09:11 |
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Basic information
Public title
Surgical stress, cardiopulmonary and immunologic effect of hybrid natural orfice transluminal endoscopic surgery (NOTES) compared to laparoscopic surgery
Acronym
Hybrid NOTES, laparoscopic surgery and surgical stress
Scientific Title
Surgical stress, cardiopulmonary and immunologic effect of hybrid natural orfice transluminal endoscopic surgery (NOTES) compared to laparoscopic surgery
Scientific Title:Acronym
Hybrid NOTES, laparoscopic surgery and surgical stress
Region
| Japan |
Condition
Condition
Gastrointestinal Stromal Tumors of the Stomach.
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the surgical stress and cardiopulmonary and immunologic effects of hybrid NOTES compared with laparoscopic surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Immunologic parameters included white blood cell count, tumor necrosis factor-a, interleukin-1B, and interleukin-6 at before and immediately after the operation, post operative day 1, 3 and 5.Surgical stress parameters included blood sugar and cortisol.
Key secondary outcomes
Cardiopulmonary parameters included heart rate, blood pressure, saturation pulse oximetry, intratracheal pressure, and arterial blood gases.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Endoscopic and laparoscopic surgery for gastrointestinal stromal tumor in the stomach.
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
The patients who have gastric endogastic type of gastrointestinal stromal tumor.Those who signed informed consent.
Key exclusion criteria
The patient's exclusion criteria for the present study were as follows: 1) lesions that could not result in en bloc resection 2) severe organ failure; and 3) an inability to obtain informed consent.
Those who are judged unable to withstand surgery by the investigators with the preoperative assessment.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirohito Mori |
Organization
Kagawa University,Faculty of Medicine
Division name
Department of Gastroenterology and Neurology
Zip code
Address
1750-1, Miki-cho, Kita-gun, Kagawa Prefecture, 761-0793
TEL
+81-87-891-2156
hiro4884@med.kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirohito Mori |
Organization
Kagawa University,Faculty of Medicine
Division name
Department of Gastroenterology and Neurology
Zip code
Address
1750-1, Miki-cho, Kita-gun, Kagawa Prefecture, 761-0793
TEL
+81-87-891-2156
Homepage URL
sannai@med.kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University, Department of Gastroenterology and Neurology
Institute
Department
Personal name
Funding Source
Organization
Kagawa University, Department of Gastroenterology and Neurology
Organization
Division
Category of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | 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
| 2013 | Year | 06 | Month | 30 | Day |
Last modified on
| 2015 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012956
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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