UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021117
Receipt number R000024365
Scientific Title Long-term oncological feasibility of laparoscopic D1 plus lymphadenectomy for rectal cancer with clinically negative lymph nodes and its preoperative CT evaluation
Date of disclosure of the study information 2016/02/20
Last modified on 2016/02/20 22:21:45

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Long-term oncological feasibility of laparoscopic D1 plus lymphadenectomy for rectal cancer with clinically negative lymph nodes and its preoperative CT evaluation

Acronym

laparoscopic D1 plus lymphadenectomy for rectal cancer

Scientific Title

Long-term oncological feasibility of laparoscopic D1 plus lymphadenectomy for rectal cancer with clinically negative lymph nodes and its preoperative CT evaluation

Scientific Title:Acronym

laparoscopic D1 plus lymphadenectomy for rectal cancer

Region

Japan


Condition

Condition

Rectal cancer without lymph node metastasis on preoperative computed tomography scans

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate optimal lymphadenectomy for the rectal cancer without lymphadenopathy on preoperative CT scans

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Disease specific survival rate and recurrence free survival rate were compared for at least three-year follow-up.

Key secondary outcomes

Feasibility of defining more than 10 mm of the minor axis of the lymph nodes as positive


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

A laparoscopic low or high anterior resection with a D2 lymphadenectomy was performed. The inferior mesenteric artery was exposed at the root of the left colic artery branching and clipped and dissected preserving the left colic artery. The iliac or obturator lymph nodes were not dissected.

Interventions/Control_2

A laparoscopic low or high anterior resection with D1 plus lymphadenectomy was performed.
The inferior mesenteric artery was dissected by using a surgical stapler with implantable staples or exposed and clipped at the site between the root of left colic artery and superior rectal artery. We tried to cut and dissect as close to the root of the left colic artery as possible from the information of preoperative CT scans and intraoperative findings, when we used surgical stapler with implantable staples. The iliac or obturator lymph nodes were not dissected.

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

44 years-old <=

Age-upper limit

88 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients who were diagnosed with rectal cancer without lymph node metastasis by colonoscopies and CT scans

Key exclusion criteria

Patients diagnosed with lymph node metastasis, who were treated by chemotherapy and/or radiation therapy preoperatively were excluded. One patient who died of pneumonia within 30 days after surgery was also excluded.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takeshi Yanagita

Organization

Kameda medical center

Division name

Department of gastroenterological surgery

Zip code


Address

929 Higashi-cho Kamogawa city Chiba prefecture, Japan

TEL

81-4-7099-1111

Email

tkshyngtx@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Takeshi Yanagita

Organization

Kameda medical center

Division name

Department of gastroenterological surgery

Zip code


Address

929 Higashi-cho Kamogawa city Chiba prefecture, Japan

TEL

81-4-7099-1111

Homepage URL


Email

tkshyngtx@gmail.com


Sponsor or person

Institute

Takeshi Yanagita

Institute

Department

Personal name



Funding Source

Organization

Kameda medical center

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


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

Kameda medical center (Chiba)


Other administrative information

Date of disclosure of the study information

2016 Year 02 Month 20 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Completed

Date of protocol fixation

2005 Year 09 Month 01 Day

Date of IRB


Anticipated trial start date

2005 Year 09 Month 13 Day

Last follow-up date

2016 Year 02 Month 01 Day

Date of closure to data entry

2016 Year 02 Month 21 Day

Date trial data considered complete

2016 Year 02 Month 21 Day

Date analysis concluded

2016 Year 02 Month 21 Day


Other

Other related information



Management information

Registered date

2016 Year 02 Month 20 Day

Last modified on

2016 Year 02 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024365


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name