Endoscopic Submucosal Dissection Versus Laparoscopic Resection for Early Colorectal Neoplasms

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01112046
• Other study ID #: CRE-2009.625
• Status: Recruiting
• Phase: Phase 3
• First received: April 26, 2010
• Last updated: February 10, 2014
• Start date: April 2010
• Est. completion date: April 2015

Study information

• Verified date: February 2014
• Source: Chinese University of Hong Kong
• Contact: Simon SM Ng, MD
• Phone: (852) 2632 1495
• Email: simonng[@]surgery.cuhk.edu.hk
• Is FDA regulated: No
• Health authority: Hong Kong: Joint The Chinese University of Hong Kong - New Territories East Cluster Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Neoplasms

Intervention

Procedure:
• Endoscopic submucosal dissection
Endoscopic treatment (performed under conscious sedation) using specific endoscopic knives
• Laparoscopic resection
Surgical treatment performed under general anesthesia

Locations

Country	Name	City	State
China	Prince of Wales Hospital, The Chinese University of Hong Kong	Hong Kong

Sponsors (3)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Queen Elizabeth Hospital, Hong Kong, United Christian Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short-term morbidity		Up to 1 month	Yes
Secondary	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	No
Secondary	Post-ESD/surgery recovery	Time to resume normal diet, time to walk independently, and duration of hospital stay	Up to 1 month	No
Secondary	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	No
Secondary	Direct and indirect medical costs		Up to 1 year	No
Secondary	Local recurrence		Within 5 years after ESD/surgery	No