UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034318 |
|---|---|
| Receipt number | R000039123 |
| Scientific Title | Non-inferiority study of GM142 compared to Seprafilm in patients with primary rectal cancer scheduled for temporary loop ileostomy during laparoscopic surgery -Multicenter, randomized, single blind, parallel-group comparison study- |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2022/04/07 13:31:35 |
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Basic information
Public title
Non-inferiority study of GM142 compared to Seprafilm in patients with primary rectal cancer scheduled for temporary loop ileostomy during laparoscopic surgery
-Multicenter, randomized, single blind, parallel-group comparison study-
Acronym
A clinical trial of GM142 in patients with intestinal surgery
Scientific Title
Non-inferiority study of GM142 compared to Seprafilm in patients with primary rectal cancer scheduled for temporary loop ileostomy during laparoscopic surgery
-Multicenter, randomized, single blind, parallel-group comparison study-
Scientific Title:Acronym
A clinical trial of GM142 in patients with intestinal surgery
Region
| Japan |
Condition
Condition
Rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to verify non-inferiority of GM142 compared to Seprafilm on the prevention of adhesion formation in patients with primary rectal cancer scheduled for temporary loop ileostomy during laparoscopic surgery by using GM142 or Seprafilm, and to compare the safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The evaluation of presence/absence of adhesion
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
GM142(Adhesion Barrier)
Interventions/Control_2
Seprafilm
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. Patients with initial and primary rectal cancer
2. Patients with cStage 0 to cStage III
3. Patients who are scheduled to undergo laparoscopic rectal resection in which a temporary ileostomy is performed.
4. Patients who are scheduled to undergo the closure of ileostomy 8 to 48 weeks after initial surgery.
5. Patients aged 20 years or older at the time of obtaining an informed consent
6. Patients who are fully informed about this study prior to the participation, understand the content, and give a written informed consent of their own free will
Key exclusion criteria
Patients who have the following symptoms, surgery, or problems, etc.:
(Preoperative criteria)
1. Scheduled to undergo laparotomy for rectal resection.
2. Having a history of surgery in peritoneal cavity, except operation for appendicitis.
3. cStage IV
4. Scheduled to remove specimens from the site other than the midline incision.
5. Scheduled to undergo ileostomy at umbilical region.
6. ECOG performance status of 3 or greater
7. Peritonitis
8. Subject to emergency operation
9. Gelatin hypersensitivity
10. A history of severe drug allergy
11. Severe diabetes or anomaly of saccharometabolism
12. Significant obesity (BMI of 35 or higher)
13. Requiring chronic treatment with corticosteroids.
14. Scheduled to undergo chemotherapy within 2 weeks after initial surgery.
15. Scheduled to undergo surgery requiring hospital stay during the period from rectal resection to ileostomy closure.
16. Administered unapproved medications or medical devices within 12 weeks prior to obtaining the informed consent.
17. Pregnant or lactating, or wanting to become pregnant during clinical trials.
18. Undergoing dialysis due to hepatic cirrhosis, active hepatitis, or chronic renal failure.
19. Positive for any infection inappropriate for inclusion in the study based on the judgment of the principal investigator or sub-investigators.
20. Gastrointestinal perforations
21. Cancer with no schedule for radical surgery.
22. Psychiatric disease or symptom for which the enrollment in the study is judged unsuitable.
23. Considered less than one year of life expectancy.
24. Any other patients regarded unsuitable by the principal investigator or sub-investigators.
(Perioperative/Discontinuance criteria)
25. Having undergone laparotomy for rectal resection.
26. Having not undergone ileostomy.
27. Having removed specimens from the site other than the midline incision.
28. Having undergone ileostomy at umbilical region.
29. Having not applied either GM142 or Seprafilm.
Target sample size
132
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Kinugasa |
Organization
Tokyo Medical and Dental University
Division name
Graduate School of Medical and Dental Sciences, Systemic Organ Regulation, Gastrointestinal Surgery
Zip code
113-8510
Address
1-5-45 Yushima,Bunkyo-ku,Tokyo
TEL
03-5803-5252
kinugasa.srg1@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Muneaki |
| Middle name | |
| Last name | Ezu |
Organization
GUNZE LIMITED
Division name
Medical Division
Zip code
103-0027
Address
2-10-4 Nihonbashi,Chuo-ku,Tokyo
TEL
03-3276-8685
Homepage URL
GM142-all@gunze.co.jp
Sponsor or person
Institute
GUNZE LIMITED
Institute
Department
Personal name
Funding Source
Organization
GUNZE LIMITED
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University Medical Center
Address
6-100 Arai Kitamoto Saitama
Tel
048-593-7390
kmc-ctc@insti.kitasato-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
| 2018 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/full/10.1002/ags3.12544
Number of participants that the trial has enrolled
146
Results
https://onlinelibrary.wiley.com/doi/full/10.1002/ags3.12544
Results date posted
| 2022 | Year | 04 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
https://onlinelibrary.wiley.com/doi/full/10.1002/ags3.12544
Participant flow
https://onlinelibrary.wiley.com/doi/full/10.1002/ags3.12544
Adverse events
https://onlinelibrary.wiley.com/doi/full/10.1002/ags3.12544
Outcome measures
https://onlinelibrary.wiley.com/doi/full/10.1002/ags3.12544
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 28 | Day |
Last modified on
| 2022 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039123
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