Hybrid Versus Non-Hybrid Endoscopic Submucosal Dissection for Colorectal Polyps (SHORT-ESD) (SHORT-ESD)

January 14, 2025 updated by: AdventHealth

Hybrid Versus Non-Hybrid Endoscopic Submucosal Dissection for Colorectal Polyps: A Randomized Trial (SHORT-ESD)

This proposed trial will randomize 60 patients with a ≥20 mm large colorectal polyp to either undergo hybrid or non-hybrid ESD. For the primary comparison (hybrid vs non-hybrid ESD), the primary outcome will be procedure time. The study will further examine the safety and efficacy of hybrid ESD compared to non-hybrid ESD and investigate factors that may be associated with resection outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Endoscopic submucosal dissection (ESD) permits the en-bloc resection of colorectal lesions irrespective of size. En-bloc resection, as opposed to piecemeal endoscopic mucosal resection (EMR) of colorectal polyps ≥20 mm, provides a more definitive resection specimen for accurate histopathological assessment, and is associated with a low risk for recurrence1,2.

Current guidelines from the Japan Gastroenterological Endoscopy Society (JGES), the European Society of Gastrointestinal Endoscopy (ESGE), and the American Gastroenterology Association (AGA), recommend ESD as a preferred strategy for superficial colorectal lesions with suspicion for advanced neoplasia or early cancer (e.g. depressed morphology, advanced surface pattern, nongranular laterally spreading tumor [LST-NG], polyps, ≥20 mm in size)3-5. In these cases, ESD procures an ideal pathological specimen for submucosal staging, provides curative intent, and prevents unnecessary surgery for lesions with low risk for lymph node metastasis6 Yet, ESD in the United States and Europe has been primarily restricted to specialized centers for a variety of reasons, notably due to its technical complexity7. Technical difficulty resides primarily in the process of submucosal dissection using endoknives. Maintaining adequate visualization of the dissection plane during ESD is often regarded the rate-limiting step (Figure 1 Non-hybrid ESD). Other factors, including maintaining the endoknife parallel to the dissection plane and accounting for paradoxical scope movements due to patient-related factors (e.g. colon redundancy, peristalsis, breathing movements) represent formidable challenges during colorectal ESD. These technical hurdles can lead to prolonged procedural times and higher risk for adverse events8. Overcoming these barriers is necessary for the safe and widespread adoption of ESD in Western clinical practice.

To reduce the technical difficulty of colorectal ESD, several techniques have been introduced, such as the introduction of traction techniques to assist with the exposure and visualization of the dissection plane during ESD8. However, many of these traction techniques require additional devices, second-hand assistance, and have a learning curve of their own9-12. Hence, many of these methods have not been widely adopted.

Hybrid ESD is a modified ESD technique that uses snare-assisted resection as part of the procedure7. With hybrid ESD, a circumferential mucosal incision followed by limited submucosal dissection is performed. Following this, a snare is placed around the lesion, slowly closed to allow resection by traversing the submucosal space. The main advantage of this method is that it reduces the need for deep submucosal dissection underneath the center of the lesion, which intuitively would reduce procedural time and risk of adverse events. Furthermore, snare resection is a technique that is familiar to most endoscopists in the West.

A recent systematic review and meta-analysis evaluated outcomes between hybrid ESD and conventional ESD for colorectal lesions7. In aggregate, when compared with conventional ESD among over 2000 patients, hybrid ESD was associated with a shorter procedural time (mean difference of 18.5 minutes, p=0.003). The rate of adverse events decreased for hybrid ESD compared with conventional ESD (odds ratio 1.56; p=0.04), but no difference when stratified by perforation rate (odds ratio 1.86; p=0.11) or delayed bleeding (odds ratio 1.15; p=0.7). Conversely, hybrid ESD was associated with a lower rate of en-bloc resection when compared to conventional ESD (odds ratio 0.31; p<0.001)7. There are several limitations with this data. For one, 14 out of the 16 studies included in this analysis were observational in design. Hence, important factors, such as lesion size, endoscopist experience, type of snare, were not accounted for in most of the studies. Notably, the meta-analysis included studies in which hybrid ESD was used as a rescue therapy after failed conventional ESD, which further complicates the interpretability of the results. Furthermore, only 4 studies originated from the West (Europe) and none from the United States, limiting the generalizability of this technique by US endoscopists. In all, high-quality studies evaluating hybrid ESD for colorectal lesions are needed.

This proposed trial will randomize 60 patients with a ≥20 mm large colorectal polyp to either undergo hybrid or non-hybrid ESD. For the primary comparison (hybrid vs non-hybrid ESD), the primary outcome will be procedure time. The study will further examine the safety and efficacy of hybrid ESD compared to non-hybrid ESD and investigate factors that may be associated with resection outcomes.

This trial is timely, as ESD has been endorsed in recent years by multiple international and national GI societies. This study will provide information on the feasibility of hybrid ESD as a modified technique that can be more widely adopted in the West. The findings of this trial will therefore help identify a safe and practical ESD technique for large colorectal polyps.

Study Type

Interventional

Enrollment (Actual)

247

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32611
        • University of Florida
      • Orlando, Florida, United States, 32803
        • AdventHealth Orlando
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Parkview
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Any patient ≥18 years
  • Ability to provide informed consent
  • Patient scheduled to undergo colonoscopy with endoscopic resection of colorectal polyps
  • Non-pedunculated polyps measuring ≥20 mm in lateral diameter by endoscopic estimation

Exclusion Criteria:

  • Age < 18 years
  • Inability to provide informed consent
  • Pedunculated polyps (as defined by Paris classification type Ip)8
  • Lesions < 20 mm in lateral diameter
  • Suspected adenocarcinoma with deep submucosal invasion (e.g. Paris III morphology, Kudo type Vn pit pattern)4,13
  • Previously attempted incomplete endoscopic resection (EMR) of the lesion
  • Uncorrected coagulopathy defined as an elevated INR ≥ 1.5 and/or platelet count < 50,000
  • Any standard contraindication to anesthesia and/or colonoscopy
  • Pregnancy or lactating women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hybrid ESD
Hybrid ESD is a modified ESD technique that uses snare-assisted resection as part of the procedure. With hybrid ESD, a circumferential mucosal incision followed by limited submucosal dissection is performed. Following this, a snare is placed around the lesion, slowly closed to allow resection by traversing the submucosal space
Procedure: Hybrid ESD
Method of removing colon lesion
Other Names:
  • Endoscopic Mucosal Resection
Active Comparator: Non-Hybrid ESD
A partial or complete circumferential mucosal incision will be performed to expose the submucosa around and underneath the polyp. Endoscopic resection will then proceed via conventional ESD, submucosal tunneling or pocket technique.
Procedure: Non-hybrid ESD
Method of removing colon lesion
Other Names:
  • Endoscopic Mucosal Resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
• The primary endpoint is to compare procedural time between hybrid vs non-hybrid ESD.
Time Frame: 1 day

The primary endpoint is to compare procedural time between hybrid vs non-hybrid ESD. Procedure time is defined as the time from the beginning of the submucosal injection to completion of the ESD, defined as complete removal of the polyp from the colonic wall and all interventions for any intraprocedural adverse events.

Procedure speed will be calculated by diving the area of the resected specimen by the procedure time (cm2/minute). The following formula will be used to calculate the area: π (3.14) x 0.25 x long axis x short axis/procedure time.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
En-Bloc resection rate
Time Frame: 1 day
• En-Bloc resection rate: Compare en-bloc resection rate between the two arms (hybrid ESD vs non-hybrid ESD). En-bloc resection is defined as resection of the lesion in one single piece.
1 day
Completeness of resection
Time Frame: 1 day
Completeness of resection: defined as removal of all visible polyp tissue at the end of the ESD as assessed by the endoscopist.
1 day
Complete (R0) resection rate
Time Frame: 1 day
.Complete (R0) resection rate: Compare complete (R0) resection rate between the two arms (hybrid ESD vs non-hybrid ESD). Complete resection is defined as successful en-bloc resection with histologically negative lateral and deep resection margins.
1 day
Polyp recurrence
Time Frame: 6 months
Polyp recurrence: presence of biopsy proven neoplastic polyp tissue at the ESD resection site at SC following complete polyp resection
6 months
Incidence of overall severe adverse events
Time Frame: 6 months
• Incidence of overall severe adverse events: aggregate of all severe adverse events that occur at the time of the procedure (immediate complications) or during 30 days of follow-up. Severe adverse events include severe bleeding, perforation, post-polypectomy syndrome, and clinical events that require non-elective hospital admission.
6 months
Proportion of unremovable polyps
Time Frame: 6 months
• Proportion of polyps that could not be removed by the assigned treatment, required cross-over to the other arm and/or additional interventions (e.g. use of traction devices, conversion to EMR)
6 months
ESD technical difficulty:
Time Frame: 1 day
• ESD technical difficulty: difficulty of the task at hand graded by each endoscopist after each case using the National Aeronautical and Space Administration (NASA) Task Load Index (NASA-TLX)27.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth

Investigators

  • Principal Investigator: Dennis Yang, MD, AdventHealth Orlando

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2022

Primary Completion (Actual)

January 17, 2024

Study Completion (Actual)

December 19, 2024

Study Registration Dates

First Submitted

April 21, 2022

First Submitted That Met QC Criteria

April 21, 2022

First Posted (Actual)

April 26, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 14, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 1880189

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share IPD.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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