UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029228 |
|---|---|
| Receipt number | R000033367 |
| Scientific Title | Transanal or transperineal pelvic lateral lymph node dissection for lower rectal cancer and proctal cancer |
| Date of disclosure of the study information | 2017/09/22 |
| Last modified on | 2023/09/25 09:36:31 |
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Basic information
Public title
Transanal or transperineal pelvic lateral lymph node dissection for lower rectal cancer and proctal cancer
Acronym
Transanal or transperineal pelvic lateral lymph node dissection
Scientific Title
Transanal or transperineal pelvic lateral lymph node dissection for lower rectal cancer and proctal cancer
Scientific Title:Acronym
Transanal or transperineal pelvic lateral lymph node dissection
Region
| Japan |
Condition
Condition
Lower Rectal Cancer and Proctal Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We are going to perform trans anal or trans perineal pelvic lateral lymph node dissection (TapPLLD) for the lower rectal cancer and proctal cancer, which are adapted for trans anal total mesorectal excision (TaTME) and trans perineal total mesorectal excision (TpTME), with these particular pelvic lateral lymph node metastases to achieve the proper surgical field and further improvement in manipulation. We compare TapPLLD to conventional laparoscopic pelvic lateral lymph node dissection (LPLLD) regarding to the safety and the oncological usefulness.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Surgical bleeding and surgical time as the safety criteria, pelvic lateral lymph node harvest as the oncological criterion.
Key secondary outcomes
Post-surgical complications including dysuria, urinary tract infection, and pelvic abscess, and 3-year local recurrence rate at the pelvic lateral area post PLLD.
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
| Maneuver |
Interventions/Control_1
Transanal or transperineal pelvic lateral lymph node dissection
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1) The male patients with the lower rectal cancer and proctal cancer, which are adapted for TaTME and TpTME: which are located within about 6cm from the anal verge.
2) The male patients with the lower rectal cancer and proctal cancer, in which pelvic lateral lymph node metastases are suspected by pre-surgical examination (CT/MRI): these pelvic lateral lymph nodes are bigger than 7mm in diameter or are suspected of extra-lymph node invasion.
3) The patients who agreed the entry of this study of their own free will in writing by a principal or a substitute after they had comprehended it well by enough explanation.
Key exclusion criteria
1) The male patients with the middle or the lower rectal cancer, which are not adapted for TaTME and TpTME, which are located far from 6cm from the anal verge. Intra-corporeal transection of the rectum and intra-corporeal anastomosis are possible for rectal cancer.
2) The female patients: for whom the proper surgical field is easy to obtain. There are few cases which LPLLD is hard to achieve, because the female patients usually have the wide pelvis compared to the male.
3) When the proper surgical field or further improvement in manipulation cannot be obtained during TapPLLD, the approach method should be changed into LPLLD.
4) The patients who are inappropriate as the subjects of this study by the corresponding doctor are excluded.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Dai |
| Middle name | |
| Last name | Uematsu |
Organization
Saku Central Hospital Advanced Care Center
Division name
Digestive Surgery
Zip code
385-0051
Address
3400-28 Nakagomi, Saku, 385-0051 JAPAN
TEL
0267-62-8181
gorontadu1110@circus.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Miyuki |
| Middle name | |
| Last name | Niimi |
Organization
Saku Central Hospital Advanced Care Center
Division name
Clinical Research Center
Zip code
385-0051
Address
3400-28 Nakagomi, Saku, 385-0051 JAPAN
TEL
0267-62-8181
Homepage URL
ctroffice@sakuhp.or.jp
Sponsor or person
Institute
Saku Central Hospital Advanced Care Center
Institute
Department
Personal name
Funding Source
Organization
Saku Central Hospital Advanced Care Center
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
Saku Central Hospital Group Research Ethics Committee
Address
197 Usuda, Saku, 384-0301 JAPAN
Tel
0267-82-3131
irboffice@sakuhp.or.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
佐久総合病院 佐久医療センター
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 22 | 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
5
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Because follow-up time still hasn't been completed.
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
| 2017 | Year | 09 | Month | 13 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 21 | Day |
Last modified on
| 2023 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033367
