AzTrials
AzTrials

Rectal NeoplasmsNCT03217773

ESD Versus TAMIS for Early Rectal Neoplasms

A study testing ESD and TAMIS in people with Rectal Neoplasms, run by Chinese University of Hong Kong at 1 site in Hong Kong.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Trial summary

This is a prospective randomized controlled trial that aimed to compare the short-term clinical outcomes, functional outcomes, costs, and recurrence rates between endoscopic submucosal dissection (ESD) and transanal minimally invasive surgery (TAMIS) for early rectal neoplasms. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rectal Neoplasms
What is being tested?
ESD and TAMIS
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
1 siteHong Kong
Study dates
1 Jul 2017to Jul 2020
Phase
Interventional
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 nonpedunculated early rectal neoplasms >/= 2 cm in size in the rectum (>/= 3 cm and </= 18 cm from the anal verge) that are deemed not feasible for en bloc resection with conventional polypectomy or EMR as judged by two experienced endoscopist
  • Age of patients >18 years;
  • 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, Kudo's pit pattern Type V, or Sano's capillary pattern Type IIIB)
  • Evidence of deep invasion on endorectal ultrasonography
  • Unfavorable histopathologic features on biopsy (mucinous cancer, poor differentiation, or gross submucosal invasion)
  • Patients with other synchronous colorectal neoplasms in addition to the index neoplasm that are indicated for surgical resection
  • Patients with recurrence from previous Endoscopic Mucosal Resection or ESD
  • Patients with known metastatic disease
  • Patients with non-correctable coagulopathy

Trial locations and contacts

1 site in 1 country.

Simon SM Ng, MD contact

3505 1495

simonng@surgery.cuhk.edu.hk

Hong Kong1 site, 1 recruiting

  • Prince of Wales Hospital

    Hong Kong

    Simon SM Ng, MD, 3505 1495, simonng@surgery.cuhk.edu.hk

    Recruiting

Other trials in Hong Kong

About this study

Official title: Endoscopic Submucosal Dissection (ESD) Versus Transanal Minimally Invasive Surgery (TAMIS) for Early Rectal Neoplasms: a Prospective Randomized Controlled Trial

This is a prospective randomized controlled trial that aimed to compare the short-term clinical outcomes, functional outcomes, costs, and recurrence rates between endoscopic submucosal dissection (ESD) and transanal minimally invasive surgery (TAMIS) for early rectal neoplasms.

Read the detailed description

Background: Transanal minimally invasive surgery (TAMIS) is an effective surgical alternative to transanal excision for treating early rectal neoplasms not amenable to en bloc resection by conventional colonoscopic techniques. Endoscopic submucosal dissection (ESD) is a revolutionary endoscopic procedure that enables en bloc resection of large rectal neoplasms with low morbidity. To date, no randomized controlled trial can be found in the literature comparing the two modalities.

Objectives: To compare the short-term clinical outcomes, functional outcomes, costs, and recurrence rates between ESD and TAMIS for early rectal neoplasms.

Design: Prospective randomized controlled trial.

Subjects: One hundred and fourteen consecutive patients diagnosed with early rectal neoplasms (>/=2 cm in size and without evidence of deep submucosal invasion) that are not amenable to en bloc resection by conventional colonoscopic techniques will be recruited.

Interventions: Patients will be randomly allocated to receive either ESD or TAMIS.

Outcome measures: Primary outcome: 30-day morbidity/mortality defined by the Clavien-Dindo classification. Secondary outcomes: hospital stay, functional outcomes and quality of life, overall costs, R0 resection rate, and recurrence rate.

Conclusions: Results of the present study can provide evidence-based clarification of the efficacy and safety of ESD in treating early rectal neoplasms. The Investigators hypothesize that ESD is associated with lower morbidity, shorter hospital stay, and similar R0 resection rate when compared with TAMIS. A faster recovery and earlier discharge after ESD may reduce financial burden to the hospital/healthcare system. The results of this proposed project may have a significant impact on the future treatment strategy for early rectal neoplasms.

Being tested
ESD, TAMIS
Medical subject headings
Rectal Neoplasms

What participants receive

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

  • ESDProcedure or surgery

    Refer to arm description

  • TAMISProcedure or surgery

    Refer to arm description

Study groups in NCT03217773
Study groupRoleWhat they receive
ESDExperimentalESD is an endoscopic procedure that enables en bloc resection of large tumors in the gastrointestinal tract, irrespective of the size of the lesion. ESD uses an electrosurgical cutting device to purposely dissect the deeper layers of the submucosa to remove neoplastic mucosal lesions in a single piece.
Receives: Procedure: ESD
TAMISActive comparatorTAMIS is a minimally invasive means of removing large rectal neoplastic lesions not accessible by conventional transanal excision. It is performed using the GelPOINT path transanal access platform and laparoscopic instruments.
Receives: Procedure: TAMIS

What is being measured

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

  1. Short-term morbidity

    Short-term morbidity/mortality within 30 days after the procedure (including intraprocedural morbidity/mortality), defined by the Clavien-Dindo classification of surgical complications

    Measured: Up to 1 month

Secondary outcomes (10)

  1. En bloc resection rate

    Resection with a single piece

    Measured: Up to 1 month

  2. R0 resection rate

    Complete resection of the neoplasm with clear lateral and deep margins at histology

    Measured: Up to 1 month

  3. Time to resume normal diet

    Measured: Up to 1 month

  4. Time to walk independently

    Measured: Up to 1 month

  5. Length of hospital stay

    Measured: Up to 1 month

  6. Anal continence

    Measured by the Wexner's score

    Measured: Up to 1 year

  7. Fecal incontinence quality of life (FIQL)

    Measured by the FIQL questionnaire

    Measured: Up to 1 year

  8. Quality of life measured by the Short Form-36 (SF-36) Health Survey questionnaire

    SF-36 Health Survey is a 36-item, patient-reported survey of patient health. It consists of eight scaled scores, which are the weighted sums of the questions in their section. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

    Measured: Up to 1 year

  9. Direct medical costs

    Measured: Up to 1 year

  10. Local recurrence

    Measured: Up to 3 years

Timeline

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

  1. First posted14 Jul 2017
  2. Study start1 Jul 2017
  3. Primary completionJul 2020 (estimated)
  4. Study completionJul 2020 (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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
114 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03217773
Sponsor's protocol ID
CREC Ref. No.: 2016.680-T
Status last verified
Sep 2019
First submitted
12 Jul 2017
Last updated
17 Sep 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing ESD and TAMIS in people with Rectal Neoplasms, run by Chinese University of Hong Kong at 1 site in Hong Kong.

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 17 Sep 2019. 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 Hong Kong. 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.

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 (3505 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?

On the ClinicalTrials.gov record for NCT03217773.

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 17 Sep 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in