Endoscopic Submucosal Dissection Versus Laparoscopic Resection for Early Colorectal Neoplasms

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Chinese University of Hong Kong
Sponsor:
Collaborators:
United Christian Hospital
Queen Elizabeth Hospital, Hong Kong
Information provided by (Responsible Party):
Simon S. M. Ng, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01112046
First received: April 26, 2010
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Colorectal Neoplasms
Procedure: Endoscopic submucosal dissection
Procedure: Laparoscopic resection
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endoscopic Submucosal Dissection Versus Laparoscopic Resection for Early Colorectal Neoplasms: A Prospective Randomized Trial

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Short-term morbidity [ Time Frame: Up to 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Systemic cytokine and C-reactive protein levels [ Time Frame: Up to 5 days ] [ Designated as safety issue: No ]
    Measured at 2 hours, 8 hours, 24 hours, 48 hours, and 5 days after ESD/surgery

  • Post-ESD/surgery recovery [ Time Frame: Up to 1 month ] [ Designated as safety issue: No ]
    Time to resume normal diet, time to walk independently, and duration of hospital stay

  • Quality of life [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    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

  • Direct and indirect medical costs [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
  • Local recurrence [ Time Frame: Within 5 years after ESD/surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 124
Study Start Date: April 2010
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endoscopic submucosal dissection Procedure: Endoscopic submucosal dissection
Endoscopic treatment (performed under conscious sedation) using specific endoscopic knives
Other Name: ESD
Active Comparator: Laparoscopic resection Procedure: Laparoscopic resection
Surgical treatment performed under general anesthesia

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01112046

Contacts
Contact: Simon SM Ng, MD (852) 2632 1495 simonng@surgery.cuhk.edu.hk
Contact: Sophie SF Hon, MD (852) 2632 1495 honsf@surgery.cuhk.edu.hk

Locations
China
Prince of Wales Hospital, The Chinese University of Hong Kong Recruiting
Hong Kong, China
Contact: Simon SM Ng, MD    (852) 2632 1495    simonng@surgery.cuhk.edu.hk   
Principal Investigator: Simon SM Ng, MD         
Sub-Investigator: Philip WY Chiu, MD         
Sub-Investigator: Sophie SF Hon, MD         
Sponsors and Collaborators
Chinese University of Hong Kong
United Christian Hospital
Queen Elizabeth Hospital, Hong Kong
Investigators
Principal Investigator: Simon SM Ng, MD Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: Simon S. M. Ng, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01112046     History of Changes
Other Study ID Numbers: CRE-2009.625
Study First Received: April 26, 2010
Last Updated: February 10, 2014
Health Authority: Hong Kong: Joint The Chinese University of Hong Kong - New Territories East Cluster Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
Early colorectal neoplasms

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 16, 2014