ESD Versus TAMIS for Early Rectal Neoplasms

NCT03217773 | Unknown DMC

• 1 other identifier: CREC Ref. No.: 2016.680-T
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rectal Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• En bloc resection rate

  Up to 1 month

• R0 resection rate

  Up to 1 month

• Time to resume normal diet

  Up to 1 month

• Time to walk independently

  Up to 1 month

• Length of hospital stay

  Up to 1 month

Study Arms (2)

ESD

EXPERIMENTAL

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

TAMIS

ACTIVE COMPARATOR

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

Interventions

ESD PROCEDURE

Refer to arm description

ESD

TAMIS PROCEDURE

Refer to arm description

TAMIS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Transanal Endoscopic Surgery

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Natural Orifice Endoscopic Surgery; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Proctoscopy; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Simon SM Ng, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon SM Ng, MD

CONTACT

3505 1495; simonng@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: July 14, 2017
• Study Start: July 1, 2017
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: September 17, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)