NCT01112046

Brief Summary

This is a prospective randomized trial that aimed to compare the short-term clinical outcomes and systemic inflammatory/cytokine responses of endoscopic submucosal dissection versus laparoscopic resection for early colorectal neoplasms that are not amenable to en bloc endoscopic resection with conventional techniques.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
124

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2010

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 28, 2010

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

February 11, 2014

Status Verified

February 1, 2014

Enrollment Period

5 years

First QC Date

April 26, 2010

Last Update Submit

February 10, 2014

Conditions

Colorectal Neoplasms

Keywords

Early colorectal neoplasms

Outcome Measures

Primary Outcomes (1)

  • Short-term morbidity

    Up to 1 month

Secondary Outcomes (5)

  • Systemic cytokine and C-reactive protein levels

    Up to 5 days

  • Post-ESD/surgery recovery

    Up to 1 month

  • Quality of life

    Up to 1 year

  • Direct and indirect medical costs

    Up to 1 year

  • Local recurrence

    Within 5 years after ESD/surgery

Study Arms (2)

Endoscopic submucosal dissection

EXPERIMENTAL
Procedure: Endoscopic submucosal dissection

Laparoscopic resection

ACTIVE COMPARATOR
Procedure: Laparoscopic resection

Interventions

Endoscopic submucosal dissectionPROCEDURE

Endoscopic treatment (performed under conscious sedation) using specific endoscopic knives

Also known as: ESD
Endoscopic submucosal dissection
Laparoscopic resectionPROCEDURE

Surgical treatment performed under general anesthesia

Laparoscopic resection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with early colorectal neoplasms \>/= 2 cm in size in the colon or upper rectum (\>/= 15 cm above the anal verge) that are deemed not feasible for en bloc resection with conventional polypectomy or EMR as judged by 2 experienced endoscopists,
  • Age of patients \>18 years,
  • Patients with 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 or Kudo's pit pattern Type V),
  • Endosonographic evidence of deep invasion,
  • Unfavorable histopathologic features on biopsy (including mucinous cancer, poor differentiation, and gross submucosal invasion),
  • Patients with other synchronous colorectal neoplasms in addition to the index neoplasm that are not amenable to complete endoscopic removal, neoplasms occupying more than half circumference of the colonic wall,
  • Patients with recurrence from previous endoscopic mucosal resection or ESD,
  • Patients with known metastatic disease,
  • Patients with previous history of abdominal surgery, and patients with non-correctable coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Simon SM Ng, MD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon SM Ng, MD

CONTACT

(852) 2632 1495simonng@surgery.cuhk.edu.hk

Sophie SF Hon, MD

CONTACT

(852) 2632 1495honsf@surgery.cuhk.edu.hk

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 26, 2010

First Posted

April 28, 2010

Study Start

April 1, 2010

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

February 11, 2014

Record last verified: 2014-02

Locations

CN(1)