The Feasibility and Safety of Instruments in Transanal Total Mesorectal Excision (TaTME) for Rectal Cancer (FSI-TaTME)

October 21, 2016 updated by: Weiguo Hu, Ruijin Hospital
Colorectal cancer is one of the leading deadly diseases in the world. Due to the TME (total mesorectal excision) for the last decades, the survival and relapse rate of rectal cancer patients have been considerably improved. However, anatomical limitations in pelvic space hinder the further optimization of surgical treatment Thus, the natural orifice transluminal endoscopic surgery (NOTES) emerges as an alternative surgical strategy. Of note, transanal total mesorectal excision (TaTME) , a new invention based on TME principle, NOTES conception and single port technique, has been prevailing both in West and East nations, with or without the abdominal laparoscopic assistance. Up to date, there are various kinds of instruments and patterns to complete TaTME with comparable clinical outcomes. However, flaws in each instrument remains according to the feedbacks. This study is therefore designed to clinically evaluate the feasibility and safety of the new instruments specifically for TaTME (CS-Compact, GelPoint pathway).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Rectal cancer comprises the most in colorectal cancer around the world, among which surgery remains the optimal therapeutic intervention. The TME (Total Mesorectal Excision), proposed by Bill Heald, provides novel insights for the eradication of possible disseminated cancer cells and therefore reduces the recurrence and mortality rates. However, either laparoscopic or open TME surgery is limited by the pelvic space and further improvement. For the last decade, the emerging of the natural orifice transluminal endoscopic surgery (NOTES) offers an alternative pattern for rectal cancer surgery, among which, the TaTME (transanal total mesorectal excision) represents the most optimized surgery techniques. Derived from TME, NOTES and modified laparoscopic instruments, TaTME facilitates the dissection process of rectal cancer from caudal to cranial, from indirect to direct vision. TaTME allows for accurate confirmation of resected margin with proper transecting level, better dissection of mesorectum and protection of sphincter, a qualified end-to-end anastomosis and reduced need of endolinear stapler and possible leakage afterwards. However, various kinds of instruments and surgical procedures have been proposed to complete TaTME, all of which have been validated by preclinical and clinical trials in small size. Of note, this study is initiated to apply a suit of instruments specifically designed for TaTME ( GelPoint pathway CS-Compact) and clinically evaluate the feasibility and safety of the new instruments without comparison to other prevailing ones. The CS-Compact and GelPoint pathway has been confirmed both safe and feasible to operate in preclinical trials and clinical trials in western. This study strictly examines the corresponding issues in Chinese rectal cancer patients. The surgeons in our institute have successfully completed the training programs of TaTME in preclinical trials, in animal models and cadavers. Clinical skills and knowledge to safe operations are qualified.

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • rectal cancer patients, confirmed by the endoscopic biopsy;
  • curative rectal cancer in clinical stage with resectable lesion, the cTNM stage <T3 stage, with comparable tumor size in low or medial rectum.
  • patients' general information, 18ys<age<75ys, no restriction in genders, BMI< or =30kg/m2, no presentation of severe chronic diseases (i.e. COPD), WHO classification <2 (Zubrod-ECOG-WHO)
  • patients or representatives have agreed and signed the informed consent documents.

Exclusion Criteria:

  • have received neo-adjuvant chemotherapy or radiotherapy before operations;
  • previous surgery in pelvis
  • uncontrollable diseases such as diseases in cardiopulmonary function, chronic bronchitis, severe hepatitis/diabetes/malnutrition/renal function.
  • suffer from other malignant diseases, i.e. gastric cancer, liver cancer.
  • pregnant, lactation stage.
  • metal disorders.
  • lacking qualified compliance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: TaTME with CS-Compact (GelPoint Path)
Based on newly-designed devices tailored for transanal TME, CS-Compact, GelPoint and Octoport are employed for the clinical applications.
Device: TaTME with CS-Compact (GelPoint pathway)
Standard TaTME with circular stapler (Short and straight, CS Compact), designed for extra-corporeal and endo-anal anastomosis procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with post-operative complications
Time Frame: postoperative 30days (hospital-stay time course)
Number of participants with post-operative complications (e.g. numbers of postoperative bleeding, leakage, infections)
postoperative 30days (hospital-stay time course)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year disease free survival rate
Time Frame: postoperative 3years
3-year disease free survival rate （the period after curative treatment without any detection of disease ）, the detailed information of 3y-DFS will be obtained by period follow-up of patients by calls and outpatient checking.
postoperative 3years
3-year overall survival rate
Time Frame: postoperative 3years
3-year overall survival rate （the survival period after curative treatment ）, the detailed information of 3y-OS will be obtained by period follow-up of patients by calls and outpatient checking.
postoperative 3years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Collaborators

Shanghai Jiao Tong University School of Medicine

Investigators

  • Study Director: Wei-Guo HU, Ph.D., M.D., Ruijin Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

October 20, 2016

First Submitted That Met QC Criteria

October 21, 2016

First Posted (ESTIMATE)

October 25, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

October 25, 2016

Last Update Submitted That Met QC Criteria

October 21, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FT-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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