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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Colorectal Neoplasms

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Short-term morbidity

Outcome Time Frame:

Up to 1 month

Safety Issue:

Yes

Principal Investigator

Simon SM Ng, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chinese University of Hong Kong

Authority:

Hong Kong: Joint The Chinese University of Hong Kong - New Territories East Cluster Clinical Research Ethics Committee

Study ID:

CRE-2009.625

NCT ID:

NCT01112046

Start Date:

April 2010

Completion Date:

April 2013

Related Keywords:

  • Colorectal Neoplasms
  • Early colorectal neoplasms
  • Neoplasms
  • Colorectal Neoplasms

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