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Evaluation of the Safety and the Efficacy of Transanal TME in Difficult Cases

Primary Purpose

Rectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Transanal total mesorectal excision
Sponsored by
National Cancer Center, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring trananal TME, safety, efficacy, difficult cases

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

  • If any one of the following (1 or 2 or 3)

    1. BMI: 30 or more
    2. Tumor size: more than 7cm in long diameter
    3. CRM: mesorectal fascia involvement or less than 1 mm on MRI

Exclusion Criteria:

  • Synchronous colon cancer or other malignancy
  • Obstructing rectal cancer
  • Pregnant or breast-feeding
  • Receiving any other study agents
  • Fecal incontinence
  • History of prior colorectal cancer or inflammatory bowel disease

Sites / Locations

  • National Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transanal total mesorectal excision

Arm Description

Laparoscopy-assisted transanal total mesorectal excision

Outcomes

Primary Outcome Measures

TME quality & circumferential resection margin (CRM)
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

30-day postoperative complications
The Clavien-Dindo Classification of Surgical Complications. Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Grade III: : Requiring surgical, endoscopic or radiological intervention. Grade IV: Life-threatening complication (including CNS complications)‡ requiring IC/ICU-management. Grade V: Death of a patient
Number of harvested Lymph Nodes

Full Information

First Posted
April 5, 2015
Last Updated
September 2, 2021
Sponsor
National Cancer Center, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT02421432
Brief Title
Evaluation of the Safety and the Efficacy of Transanal TME in Difficult Cases
Official Title
A Pilot Study for the Evaluation of the Safety and the Efficacy of Transanal Total Mesorectal Excision in Difficult Cases of Laparoscopic Surgery for Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
January 1, 2018 (Actual)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is evaluation of the safety and the efficacy of transanal total mesorectal excision in difficult case. Difficult case is defined as below; - If any one of the following (1 or 2 or 3) BMI: 30 or more Tumor size: more than 7cm in long diameter CRM: mesorectal fascia involvement or less than 1 mm on MRI
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
trananal TME, safety, efficacy, difficult cases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transanal total mesorectal excision
Arm Type
Experimental
Arm Description
Laparoscopy-assisted transanal total mesorectal excision
Intervention Type
Procedure
Intervention Name(s)
Transanal total mesorectal excision
Intervention Description
Laparoscopy-assisted transanal total mesorectal excision
Primary Outcome Measure Information:
Title
TME quality & circumferential resection margin (CRM)
Description
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.
Time Frame
the day of surgery
Secondary Outcome Measure Information:
Title
30-day postoperative complications
Description
The Clavien-Dindo Classification of Surgical Complications. Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Grade III: : Requiring surgical, endoscopic or radiological intervention. Grade IV: Life-threatening complication (including CNS complications)‡ requiring IC/ICU-management. Grade V: Death of a patient
Time Frame
1 month after surgery
Title
Number of harvested Lymph Nodes
Time Frame
the day of surgery
Other Pre-specified Outcome Measures:
Title
2-year local recurrence free survival
Time Frame
2 years after surgery
Title
5-year overall survival
Time Frame
5 years after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age: 20-80 years biopsy-proven adenocarcinoma of the rectum clinical staging (c or yc): T0-3, N0-2, M0 Rectal cancer located 3-12 cm from the anal verge ECOG performance status: 2 or less If any one of the following (1 or 2 or 3) BMI: 30 or more Tumor size: more than 7cm in long diameter CRM: mesorectal fascia involvement or less than 1 mm on MRI Exclusion Criteria: Synchronous colon cancer or other malignancy Obstructing rectal cancer Pregnant or breast-feeding Receiving any other study agents Fecal incontinence History of prior colorectal cancer or inflammatory bowel disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dae Kyung Sohn, MD, PHD
Organizational Affiliation
Korea: National Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
410-769
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Evaluation of the Safety and the Efficacy of Transanal TME in Difficult Cases

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