ESD Versus TAMIS for Early Rectal Neoplasms

Rectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03217773
• Other study ID #: CREC Ref. No.: 2016.680-T
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: July 2020

Study information

• Verified date: September 2019
• Source: Chinese University of Hong Kong
• Contact: Simon SM Ng, MD
• Phone: 3505 1495
• Email: simonng[@]surgery.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Neoplasms
• Rectal Neoplasms

Intervention

Procedure:
• ESD
Refer to arm description
• TAMIS
Refer to arm description

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 1 month
Secondary	En bloc resection rate	Resection with a single piece	Up to 1 month
Secondary	R0 resection rate	Complete resection of the neoplasm with clear lateral and deep margins at histology	Up to 1 month
Secondary	Time to resume normal diet		Up to 1 month
Secondary	Time to walk independently		Up to 1 month
Secondary	Length of hospital stay		Up to 1 month
Secondary	Anal continence	Measured by the Wexner's score	Up to 1 year
Secondary	Fecal incontinence quality of life (FIQL)	Measured by the FIQL questionnaire	Up to 1 year
Secondary	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.	Up to 1 year
Secondary	Direct medical costs		Up to 1 year
Secondary	Local recurrence		Up to 3 years