ESD Versus TAMIS for Early Rectal Neoplasms

Endoscopic Submucosal Dissection (ESD) Versus Transanal Minimally Invasive Surgery (TAMIS) for Early Rectal Neoplasms: a Prospective Randomized Controlled Trial

This is a prospective randomized controlled trial that aimed to compare the short-term clinical outcomes, functional outcomes, costs, and recurrence rates between endoscopic submucosal dissection (ESD) and transanal minimally invasive surgery (TAMIS) for early rectal neoplasms.

Study Overview

• Status: Unknown
• Conditions: Rectal Neoplasms
• Intervention / Treatment: Procedure: ESD; Procedure: TAMIS

Detailed Description

Background: Transanal minimally invasive surgery (TAMIS) is an effective surgical alternative to transanal excision for treating early rectal neoplasms not amenable to en bloc resection by conventional colonoscopic techniques. Endoscopic submucosal dissection (ESD) is a revolutionary endoscopic procedure that enables en bloc resection of large rectal neoplasms with low morbidity. To date, no randomized controlled trial can be found in the literature comparing the two modalities.

Objectives: To compare the short-term clinical outcomes, functional outcomes, costs, and recurrence rates between ESD and TAMIS for early rectal neoplasms.

Design: Prospective randomized controlled trial.

Subjects: One hundred and fourteen consecutive patients diagnosed with early rectal neoplasms (>/=2 cm in size and without evidence of deep submucosal invasion) that are not amenable to en bloc resection by conventional colonoscopic techniques will be recruited.

Interventions: Patients will be randomly allocated to receive either ESD or TAMIS.

Outcome measures: Primary outcome: 30-day morbidity/mortality defined by the Clavien-Dindo classification. Secondary outcomes: hospital stay, functional outcomes and quality of life, overall costs, R0 resection rate, and recurrence rate.

Conclusions: Results of the present study can provide evidence-based clarification of the efficacy and safety of ESD in treating early rectal neoplasms. The Investigators hypothesize that ESD is associated with lower morbidity, shorter hospital stay, and similar R0 resection rate when compared with TAMIS. A faster recovery and earlier discharge after ESD may reduce financial burden to the hospital/healthcare system. The results of this proposed project may have a significant impact on the future treatment strategy for early rectal neoplasms.

• Study Type: Interventional
• Enrollment (Anticipated): 114
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Simon SM Ng, MD; Phone Number: 3505 1495; Email: simonng@surgery.cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Prince of Wales Hospital
    • Contact: Simon SM Ng, MD; Phone Number: 3505 1495; Email: simonng@surgery.cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients diagnosed with nonpedunculated early rectal neoplasms >/= 2 cm in size in the rectum (>/= 3 cm and </= 18 cm from the anal verge) that are deemed not feasible for en bloc resection with conventional polypectomy or EMR as judged by two experienced endoscopist
• Age of patients >18 years;
• American Society of Anesthesiologists (ASA) grading I-III
• Informed consent available

Exclusion Criteria:

• Presence of endoscopic signs of massive submucosal invasion (including excavated/depressed morphology, Kudo's pit pattern Type V, or Sano's capillary pattern Type IIIB)
• Evidence of deep invasion on endorectal ultrasonography
• Unfavorable histopathologic features on biopsy (mucinous cancer, poor differentiation, or gross submucosal invasion)
• Patients with other synchronous colorectal neoplasms in addition to the index neoplasm that are indicated for surgical resection
• Patients with recurrence from previous Endoscopic Mucosal Resection or ESD
• Patients with known metastatic disease
• Patients with non-correctable coagulopathy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ESD; ESD is an endoscopic procedure that enables en bloc resection of large tumors in the gastrointestinal tract, irrespective of the size of the lesion. ESD uses an electrosurgical cutting device to purposely dissect the deeper layers of the submucosa to remove neoplastic mucosal lesions in a single piece.	Procedure: ESD; Refer to arm description
Active Comparator: TAMIS; TAMIS is a minimally invasive means of removing large rectal neoplastic lesions not accessible by conventional transanal excision. It is performed using the GelPOINT path transanal access platform and laparoscopic instruments.	Procedure: TAMIS; Refer to arm description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short-term morbidity	Short-term morbidity/mortality within 30 days after the procedure (including intraprocedural morbidity/mortality), defined by the Clavien-Dindo classification of surgical complications	Up to 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to walk independently		Up to 1 month
Length of hospital stay		Up to 1 month
En bloc resection rate	Resection with a single piece	Up to 1 month
R0 resection rate	Complete resection of the neoplasm with clear lateral and deep margins at histology	Up to 1 month
Time to resume normal diet		Up to 1 month
Anal continence	Measured by the Wexner's score	Up to 1 year
Fecal incontinence quality of life (FIQL)	Measured by the FIQL questionnaire	Up to 1 year
Quality of life measured by the Short Form-36 (SF-36) Health Survey questionnaire	SF-36 Health Survey is a 36-item, patient-reported survey of patient health. It consists of eight scaled scores, which are the weighted sums of the questions in their section. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	Up to 1 year
Direct medical costs		Up to 1 year
Local recurrence		Up to 3 years

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: July 12, 2017
• First Submitted That Met QC Criteria: July 12, 2017
• First Posted (Actual): July 14, 2017

Study Record Updates

• Last Update Posted (Actual): September 17, 2019
• Last Update Submitted That Met QC Criteria: September 15, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: CREC Ref. No.: 2016.680-T

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No