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Phase II Clinical Trial for the Evaluation of the Efficacy of Transanal TME

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ClinicalTrials.gov Identifier: NCT02406118
Recruitment Status : Recruiting
First Posted : April 2, 2015
Last Update Posted : November 30, 2015
Sponsor:
Information provided by (Responsible Party):
Dae Kyung Sohn, National Cancer Center, Korea

Brief Summary:
The purpose of this study is evaluation of the safety and the efficacy of transanal total mesorectal excision.

Condition or disease Intervention/treatment Phase
Rectal Cancer Procedure: Transanal total mesorectal excision Phase 2

Detailed Description:
Subjects will have their rectal cancer removed using a technique combining surgery through the anus and standard laparoscopy. Transanal visualization will be using endoscopy. At the end of the procedure, the rectum will be removed though the anus or ileostomy formation site, the bowel will be re-connected to the anus, and a temporary diverting stoma will be created, which is standard of care following surgery for this type of cancer.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 49 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Clinical Trial for the Evaluation of the Efficacy of Transanal Total Mesorectal Excision
Study Start Date : March 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Transanal total mesorectal excision
Laparoscopy-assisted transanal total mesorectal excision
Procedure: Transanal total mesorectal excision
Subjects will have their rectal cancer removed using a technique combining surgery through the anus and standard laparoscopy. Transanal visualization will be using endoscopy. At the end of the procedure, the rectum will be removed though the anus or ileostomy formation site, the bowel will be re-connected to the anus, and a temporary diverting stoma will be created, which is standard of care following surgery for this type of cancer.
Other Name: Laparoscopy-assisted transanal TME




Primary Outcome Measures :
  1. TME quality & circumferential resection margin (CRM) [ Time Frame: the day of trananal TME ]

    The quality of the mesorectum was determined using pathology reports and scored using three grades:

    • Complete: intact mesorectum with only minor irregularities of a smooth mesorectal surface. No defect is deeper than 5 mm, and there is no coning toward the distal margin of the specimen. There is a smooth circumferential resection margin on slicing.
    • Nearly complete: moderate bulk to the mesorectum, but irregularity of the mesorectal surface. Moderate coning of the specimen is allowed. At no site is the muscularis propria visible, with the exception of the insertion of the levator muscles.
    • Incomplete: little bulk to mesorectum with defects down onto muscularis propria and/or very irregular circumferential resection margin.


Secondary Outcome Measures :
  1. 30-day postoperative complications [ Time Frame: 1 month after surgery ]
  2. Number of harvested Lymph Nodes [ Time Frame: the day of surgery ]

Other Outcome Measures:
  1. 2-year local recurrence free survival [ Time Frame: 2 years after surgery ]
  2. 5-year overall survival [ Time Frame: 5 years after surgery ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age: 20-80 years
  2. biopsy-proven adenocarcinoma of the rectum
  3. clinical staging (c or yc): T0-3, N0-2, M0
  4. Rectal cancer located 3-12 cm from the anal verge
  5. ECOG performance status: 2 or less
  6. BMI: less than 30

Exclusion Criteria:

  1. Synchronous colon cancer or other malignancy
  2. Obstructing rectal cancer
  3. Pregnant or breast-feeding
  4. Receiving any other study agents
  5. Fecal incontinence
  6. History of prior colorectal cancer or inflammatory bowel disease
  7. Tumor size: more than 7cm in long diameter
  8. CRM: mesorectal fascia involvement or less than 1 mm on MRI

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02406118


Locations
Korea, Republic of
National Cancer Center Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Contact: Dae Kyung Sohn    +82‐31‐920‐0000    gsgsbal@ncc.re.kr   
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Principal Investigator: Dae Kyung Sohn NCC,Korea

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dae Kyung Sohn, MD., PHD, Center for Colorectal Cancer, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT02406118     History of Changes
Other Study ID Numbers: NCC2015-0033
First Posted: April 2, 2015    Key Record Dates
Last Update Posted: November 30, 2015
Last Verified: November 2015

Keywords provided by Dae Kyung Sohn, National Cancer Center, Korea:
transanal TME quality
CRM