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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029228
Receipt No. 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 2019/03/26

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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
Email 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
Email ctroffice@sakuhp.or.jp

Sponsor
Institute Saku Central Hospital Advanced Care Center
Institute
Department

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
Email ctroffice@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
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
2017 Year 09 Month 13 Day
Date of IRB
2017 Year 11 Month 07 Day
Anticipated trial start date
2017 Year 11 Month 07 Day
Last follow-up date
2023 Year 09 Month 11 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
2019 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033367

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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