Transanal Versus Laparoscopic Total Mesorectal Excision For Rectal Cancer (TLTME)

November 30, 2017 updated by: Shanghai Minimally Invasive Surgery Center

Transanal Versus Laparoscopic Total Mesorectal Excision for Mid And Low Rectal Cancer in China (TLTME): a Single-center Randomized Clinical Trial

Total mesorectal excision (TME) has been prevailingly accepted as a crucial surgical intervention within the latest oncological therapeutic regime for mid-low rectal cancer. However, surgical dissection under the restricted pelvic anatomical structure, added by obesity and many other general factors, remains challenging for classical open and laparoscopic patterns, particularly in male cases. The introduction of transanal total mesorectal excision (TaTME) offers an optimal pattern for the surgical resection of mid-low rectal cancer, circumventing the conventional anatomical limits while bringing forward considerable advantages by direct dissection. Noteworthy, the surgical techniques of TaTME is initially established, with the mortality/morbidity and the oncological safety unverified. The studies that focus on the comparison between TaTME and laparoscopic TME (LaTME) remain sparse. Therefore, the features of TaTME, both in short and long terms, await further consolidation by clinical trials. Herein, this single centered, interventional study protocol is established to collect initial clinical data on both the safety and efficacy of the TaTME in comparison with LaTME in East Chinese patients with mid-low rectal cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Background: Transanal total mesorectal excision (TaTME) is increasingly accepted as one of the alternative patterns for the resectable rectal cancer worldwide since its first appearance. For mid-low rectal cancer, TaTME features superior viewpoints and direct access to mobilize the primary lesion without the pelvic anatomic limits. Therefore, the matured TaTME technique could deliver satisfactory clinic outcomes in both surgical and oncological senses. However, the studies that designed to compare the feasibility and repeatability of TaTME with conventional laparoscopic total mesorectal excision (LaTME) remain sparse and limited.

Study Objective: Evaluation of short-term mortality and morbidity, long term overall survival and disease-free survival as well as quality of life in rectal cancer patients in East China.

Study Design: This study is a prospective, single-center, randomized clinical trial with a central monitored electronic data processing system. Corresponding randomization, data collection and comparative analysis will be conducted based on the research group discussion. According to the non-inferiority principle, the power is 80% and the α is 0.05 with 10% margin delta (δ). Total patients will be 258, with 129 in each group given 10% lost in follow-up.

Study Endpoints: The primary outcomes measures will be the Disease-free survival (3-years). The secondary outcomes measures will be overall survival (3-years), mesorectal completeness (the quality of the TME specimen, complete, near complete, incomplete), positive circumferential resection margin (CRM), number of retrieved lymph nodes, morbidity rate, mortality rate.

Study Type

Interventional

Enrollment (Anticipated)

258

Phase

  • Not Applicable

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:

  1. Rectal adenocarcinoma validated by pathologists, pathological estimated stage II-III;
  2. Mid and low rectal tumor sites, parameter less than 5cm, below the level of peritoneal reflection and verified by MRI, distance to anus less than 7 cm;
  3. Curative rectal cancer surgery;
  4. No evidence of distance metastasis lesions;
  5. T1-3, N0-2, with or without neoadjuvant therapeutic history;
  6. Applied to laparoscopic surgery;
  7. Absent of previous malignancy-treated history
  8. No gender restriction, age between 18 and 75, Body Mass Index less than 32;
  9. Approved by multiple disciplinary teamwork therapeutic group
  10. Consent by the patient and the family.

Exclusion Criteria:

  1. Mile's surgery is additionally required;
  2. Tumor invasion is validated on adjacent organs, such as prostate;
  3. Recurrent rectal cancer, require secondary surgical interventions;
  4. Previous history of malignant diseases or inflammatory bowel diseases within recent five years;
  5. Emergent surgery accompanied by bowel obstruction or intestinal perforation;
  6. Previous history of colorectal surgery, unnatural anatomical structure;
  7. Contraindication to general anesthesia (class IV or V in American Society of Anesthesiologists (ASA), or Eastern Cooperative Oncology Group (ECOG) score >=2)
  8. Pregnant or breast-feeding patients;
  9. Mental disorder validated by psychiatrists.
  10. Uncontrolled infectious diseases;
  11. Participants within other related clinical trials that may influence the conclusion of this trial;

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: transanal total mesorectal excision
Transanally, the rectum is mobilized through the mesorectal plane according to the TME principles, assisted by the transanal surgical platform (Transanally curable surgical resection).
Procedure: Transanally curable surgical resection
Transanally, the rectal cancer will be mobilized with oncological principle of total mesorectal excision
ACTIVE_COMPARATOR: laparoscopic total mesorectal excision
By standard laparoscopic techniques, the rectal cancer will be resected by the conventional laparoscopic TME (LaTME).
Procedure: Laparoscopic total mesorectal excision
Conventionally by laparoscopic surgery, the rectal cancer will be mobilized with oncological principle of total mesorectal excision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival (DFS)
Time Frame: 3-years
3-year DFS
3-years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 3-years
3-years OS
3-years
mesorectal completeness
Time Frame: 3-years
(the quality of the TME specimen, complete, near complete, incomplete)
3-years
positive circumferential resection margin
Time Frame: 3-years
the rate of positive circumferential resection margin (CRM)
3-years
number of retrieved lymph nodes
Time Frame: 3-years
retrieved lymph nodes
3-years
morbidity rate
Time Frame: 3-years
morbidity rate(number of intr-and post-operative encountered cases)
3-years
mortality rate
Time Frame: 3-years
(number of intr-and post-operative encountered complications)
3-years

Collaborators and Investigators

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

Sponsor

Shanghai Minimally Invasive Surgery Center

Investigators

  • Study Director: Minhua Zheng, M.D., PhD., MISC, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University

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 (ANTICIPATED)

January 1, 2018

Primary Completion (ANTICIPATED)

January 1, 2021

Study Completion (ANTICIPATED)

January 1, 2022

Study Registration Dates

First Submitted

November 26, 2017

First Submitted That Met QC Criteria

November 30, 2017

First Posted (ACTUAL)

December 2, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 2, 2017

Last Update Submitted That Met QC Criteria

November 30, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MISC-TaTME

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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