Endoscopic Submucosal Dissection Versus Laparoscopic Resection for Early Colorectal Neoplasms

Endoscopic Submucosal Dissection Versus Laparoscopic Resection for Early Colorectal Neoplasms: A Prospective Randomized Trial

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Neoplasms
• Intervention / Treatment: Procedure: Endoscopic submucosal dissection; Procedure: Laparoscopic resection

Detailed Description

Colonoscopy plays an increasingly important role in the diagnosis and treatment of colorectal pathologies. The recent progress in endoscopic technologies and interest in colorectal cancer screening have enabled the diagnosis of a larger number of early colorectal neoplasms, including benign polyps and early cancers. Colonoscopic polypectomy remains the cornerstone of therapy for the majority of colorectal polyps and helps prevent colorectal cancer. However, if colorectal neoplasms are too large or cannot be removed "en bloc" endoscopically, operative procedures are required to reduce risks of incomplete removal and local recurrence. Laparoscopic resection represents a minimally invasive alternative for treating colorectal neoplasms that are not amenable to en bloc endoscopic resection. However, laparoscopic surgery has to be done under general anesthesia, is associated with operative morbidity, and is expensive.

Endoscopic submucosal dissection (ESD) is a revolutionary endoscopic procedure that enables en bloc resection of large gastrointestinal tumors, irrespective of the size of the lesion. ESD, which was pioneered in Japan for the treatment of early gastric neoplasms, has now been successfully applied to the colon and rectum. ESD has been shown by recent studies to be a safe and effective resection technique for large early colorectal neoplasms. However, no report can be found in the literature comparing ESD and laparoscopic resection for early colorectal neoplasms that are not amenable to en bloc endoscopic resection with conventional techniques. Furthermore, it remains unclear whether ESD is less invasive than laparoscopic surgery in terms of systemic inflammatory and cytokine responses, and all these may have implications for cancer recurrence.

We propose to conduct a prospective randomized trial to compare the short-term clinical outcomes and systemic inflammatory/cytokine responses of ESD versus laparoscopic resection for early colorectal neoplasms that are not amenable to en bloc endoscopic resection with conventional techniques. The overall costs of the two therapeutic approaches will also be compared. Findings of this proposed project may provide evidence-based clarification of the efficacy and safety of ESD in treating early colorectal neoplasms. We hypothesize that ESD is associated with lower morbidity, earlier recovery, shorter hospital stay, and lower costs when compared with laparoscopic resection. A faster recovery and earlier discharge after ESD may reduce financial burden to the hospital and health care system. The results of this proposed project may have a significant impact on the future treatment strategy for early colorectal neoplasms, and may provide new insights into the systemic inflammatory responses of ESD.

• Study Type: Interventional
• Enrollment (Anticipated): 124
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Hong Kong, China
    • Recruiting
    • Prince of Wales Hospital, The Chinese University of Hong Kong
    • Sub-Investigator: Sophie SF Hon, MD

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 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Endoscopic submucosal dissection	Procedure: Endoscopic submucosal dissection; Endoscopic treatment (performed under conscious sedation) using specific endoscopic knives; Other Names: ESD
ACTIVE_COMPARATOR: Laparoscopic resection	Procedure: Laparoscopic resection; Surgical treatment performed under general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Short-term morbidity	Up to 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systemic cytokine and C-reactive protein levels	Measured at 2 hours, 8 hours, 24 hours, 48 hours, and 5 days after ESD/surgery	Up to 5 days
Post-ESD/surgery recovery	Time to resume normal diet, time to walk independently, and duration of hospital stay	Up to 1 month
Quality of life	Measured by Short Form-36 (SF-36) and European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaires at 3, 6, 9, and 12 months after ESD/surgery	Up to 1 year
Direct and indirect medical costs		Up to 1 year
Local recurrence		Within 5 years after ESD/surgery

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Collaborators: Queen Elizabeth Hospital, Hong Kong; United Christian Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (ANTICIPATED): April 1, 2015
• Study Completion (ANTICIPATED): April 1, 2015

Study Registration Dates

• First Submitted: April 26, 2010
• First Submitted That Met QC Criteria: April 27, 2010
• First Posted (ESTIMATE): April 28, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): February 11, 2014
• Last Update Submitted That Met QC Criteria: February 10, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Early colorectal neoplasms
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplasms; Colorectal Neoplasms
• Other Study ID Numbers: CRE-2009.625