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Colorectal NeoplasmsPhase 3NCT01112046

Endoscopic Submucosal Dissection Versus Laparoscopic Resection for Early Colorectal Neoplasms

A Phase 3 study testing Endoscopic submucosal dissection and Laparoscopic resection in people with Colorectal Neoplasms, run by Chinese University of Hong Kong at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Neoplasms
What is being tested?
Endoscopic submucosal dissection and Laparoscopic resection
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
1 siteChina
Study dates
Apr 2010to Apr 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting
  • Prince of Wales Hospital, The Chinese University of Hong Kong

    Hong Kong

    Simon SM Ng, MD, (852) 2632 1495, simonng@surgery.cuhk.edu.hk

    Simon SM Ng, MD

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Endoscopic submucosal dissection, Laparoscopic resection
Keywords
Early colorectal neoplasms
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endoscopic submucosal dissectionProcedure or surgery

    Also called ESD

    Endoscopic treatment (performed under conscious sedation) using specific endoscopic knives

  • Laparoscopic resectionProcedure or surgery

    Surgical treatment performed under general anesthesia

Study groups in NCT01112046
Study groupRoleWhat they receive
Endoscopic submucosal dissectionExperimentalNot described
Receives: Procedure: Endoscopic submucosal dissection
Laparoscopic resectionActive comparatorNot described
Receives: Procedure: Laparoscopic resection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Short-term morbidity

    Measured: Up to 1 month

Secondary outcomes (5)
  1. Systemic cytokine and C-reactive protein levels

    Measured at 2 hours, 8 hours, 24 hours, 48 hours, and 5 days after ESD/surgery

    Measured: Up to 5 days

  2. Post-ESD/surgery recovery

    Time to resume normal diet, time to walk independently, and duration of hospital stay

    Measured: Up to 1 month

  3. 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

    Measured: Up to 1 year

  4. Direct and indirect medical costs

    Measured: Up to 1 year

  5. Local recurrence

    Measured: Within 5 years after ESD/surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionApr 2015 (estimated)
  4. Study completionApr 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
124 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01112046
Sponsor's protocol ID
CRE-2009.625
Status last verified
Feb 2014
First submitted
26 Apr 2010
Last updated
11 Feb 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Endoscopic submucosal dissection and Laparoscopic resection in people with Colorectal Neoplasms, run by Chinese University of Hong Kong at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Simon SM Ng, MD ((852) 2632 1495, simonng@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Short-term morbidity (time frame: Up to 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2014.

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