Clinical trial NCT01112046: Endoscopic Submucosal Dissection Versus Laparoscopic Resection for Early Colorectal Neoplasms
Official title: Endoscopic Submucosal Dissection Versus Laparoscopic Resection for Early Colorectal Neoplasms: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Colorectal Neoplasms
Keywords: Early colorectal neoplasms
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: United Christian Hospital
name: Queen Elizabeth Hospital, Hong Kong
First posted: 2010-04-28
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Short-term morbidity
timeFrame: Up to 1 month
Secondary outcomes:
measure: Systemic cytokine and C-reactive protein levels
timeFrame: Up to 5 days
measure: Post-ESD/surgery recovery
timeFrame: Up to 1 month
measure: Quality of life
timeFrame: Up to 1 year
measure: Direct and indirect medical costs
timeFrame: Up to 1 year
measure: Local recurrence
timeFrame: Within 5 years after ESD/surgery
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Prince of Wales Hospital, The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Simon SM Ng, MD
role: PRINCIPAL_INVESTIGATOR
References: