Traction Device for Digestive System Tumors

Recruiting at 1 trial location

Overseen By Michael Mercado, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Disqualifiers: Pregnancy, Pedunculated lesions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

150 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this prospective, randomized, controlled trial conducted at Baylor St. Luke's Medical Center is to compare the effectiveness and clinical outcomes of using a traction device in colonic endoscopic submucosal dissection (ESD) to those of using conventional ESD. The investigators of this study hypothesize that use of the traction device will help expedite colonic endoscopic submucosal dissections.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Traction Device for Digestive System Tumors?

Research shows that using traction devices during endoscopic submucosal dissection (ESD) helps improve visibility and control, making the procedure safer and more effective for removing large tumors in the digestive system. ^{1 2 3 4 5}

Is the traction device for digestive system tumors safe for humans?

Research shows that traction devices used in endoscopic submucosal dissection (ESD) for digestive system tumors are generally safe, with studies focusing on reducing complications like bleeding and perforation. These devices, such as the S-O clip and EndoTrac, help improve the procedure's safety by providing better visualization and control during the operation. ^{1 2 3 6 7}

What makes the traction device-assisted endoscopic submucosal dissection treatment unique for digestive system tumors?

This treatment is unique because it uses a traction device to improve visibility and control during the procedure, making it easier and safer to remove tumors from the digestive system. The device allows for direct visualization of the cutting line and can be used without removing the endoscope, which helps reduce the risk of complications like bleeding and perforation. ^{1 2 3 6 8}

Research Team

Mohamed O. Othman, MD

Principal Investigator

Baylor College of Medicine

Eligibility Criteria

This trial is for adults over 18 who need an ESD procedure for colonic neoplastic lesions. They must be able to consent and have specific types of lesions, including those with scars or certain sizes. It's not for pregnant women, minors, or patients with pedunculated lesions or those near the appendix or ileocecal valve.

Inclusion Criteria

Patient is referred for ESD procedure of colonic neoplastic lesions and with one of the following criteria: A- Lesions with prior resection or with scar at any size. B- Granular lateral spreading tumors (GLST) more than 3 cm. C- Non granular lateral spreading tumors (NGLST) more than 20 mm. D- Any suspected submucosal invasion such as Paris classification II a +II or lesions with positive non lifting sign.

Patients can provide informed consent.

Exclusion Criteria

Patient is a pregnant woman.

My lesion is pedunculated.

I have lesions on my appendix or ileocecal valve.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo colonic endoscopic submucosal dissection (ESD) with or without the use of a traction device

1 day

1 visit (in-person)

Follow-up

Participants are monitored for post-procedural adverse events and abdominal pain

1 month

Follow-up visits as needed

Treatment Details

Interventions

• Endoscopic Submucosal Dissection
• Traction Device

Trial Overview The study at Baylor St. Luke's Medical Center is testing if using a traction device during colonic ESD can make the procedure faster and more effective compared to the standard method without traction.

Participant Groups

Group I: ESD with traction device Experimental Treatment 2 Interventions

ESD of target lesion will be performed with the assistance of a traction device.

Group II: Control arm Active Control 1 Intervention

ESD of target lesion will be performed without the use of a traction device

Endoscopic Submucosal Dissection is already approved in United States for the following indications:

Approved in United States as Pathfinder Endoscope Overtube for:

• Facilitate intubation, change of endoscopes, and treatment in the gastrointestinal (GI) tract in adult patients (22 years of age and older)

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Micro-Tech Endoscopy USA

Collaborator

Trials

1

Recruited

150+

Findings from Research

The S-O clip-assisted endoscopic submucosal dissection (ESD) was found to be safe and effective, successfully resecting all 27 tumors without complications, while the conventional ESD group had one micro perforation that did not require further treatment.

The procedure time for S-O clip-assisted ESD was significantly shorter (37.4 minutes) compared to conventional ESD (67.1 minutes), indicating that this new traction device can enhance the efficiency of tumor removal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective clinical trial of traction device-assisted endoscopic submucosal dissection of large superficial colorectal tumors using the S-O clip. Ritsuno, H., Sakamoto, N., Osada, T., et al.[2022]

The EndoTrac device demonstrated a 100% procedural success rate across various gastrointestinal neoplasms, indicating its effectiveness in facilitating endoscopic submucosal dissection (ESD).

Preparation times for ESD using the EndoTrac were relatively short, ranging from 2 to 6 minutes depending on the location of the lesions, suggesting that the device enhances the efficiency of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic Submucosal Dissection Using EndoTrac, a Novel Traction Device. Kaku, H., Toyonaga, T., Tanaka, S., et al.[2021]

The study introduces a novel dual-action traction device designed to improve the effectiveness of endoscopic submucosal dissection, a procedure used to remove tumors from the gastrointestinal tract.

This innovative device aims to enhance the precision and safety of the dissection process, potentially leading to better patient outcomes during gastrointestinal surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a novel dual-action traction device to facilitate endoscopic submucosal dissection. Jawaid, S., Othman, M., Keihanian, T., et al.[2023]

The study evaluated the use of a snare combined with endoclips for mucosal traction during endoscopic submucosal dissection (SC-ESD) in 54 patients with gastroesophageal neoplasias, achieving a 100% complete resection rate without significant complications.

SC-ESD allowed for effective real-time adjustment of mucosal traction, demonstrating the feasibility of both peroral external traction (PET) and peroral internal traction (PIT) in enhancing the dissection process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Snare combined with endoclips in endoscopic submucosal dissection with mucosal traction for gastroesophageal neoplasia. Zhang, Q., Yao, X., Cai, JQ., et al.[2019]

The traction ring-assisted endoscopic submucosal dissection (ESD) demonstrated a high en bloc resection rate of 95% and an R0 resection rate of 90% in a pilot study involving 20 patients, indicating its efficacy in removing colorectal lesions.

The method was found to be safe, with no significant intraoperative bleeding and only one case of perforation that did not require further intervention, suggesting that the traction ring can be effectively used across various locations in the colorectum.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New traction method (traction ring) for colorectal endoscopic submucosal dissection. Huang, XY., Ji, M., Li, P., et al.[2022]

A new traction device for endoscopic submucosal dissection (ESD) was developed, which is noninvasive and allows for a bilateral approach, showing no harmful effects on the body.

In a study of 37 patients, the device significantly reduced dissection times compared to a control group, with times decreasing from 5.8 to 2.1 minutes/cm² for easy cases and from 7.9 to 3.6 minutes/cm² for difficult cases, indicating its efficacy in facilitating rapid ESD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and clinical usability of a new traction device "medical ring" for endoscopic submucosal dissection of early gastric cancer. Matsumoto, K., Nagahara, A., Ueyama, H., et al.[2021]

This multicenter randomized controlled trial will assess the effectiveness of S-O clips in colorectal endoscopic submucosal dissection (ESD) by enrolling 200 patients across 4 hospitals in Japan, focusing on procedure time and complication rates.

Using S-O clips is expected to make ESD easier and safer by improving visualization of the submucosal layer, potentially leading to shorter procedure times and fewer complications compared to conventional ESD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter randomized control study of the efficacy of SO clip in colorectal endoscopic submucosal dissection (ESD). (SO clip study in colorectal ESD): Randomized controlled trial. Taki, S., Iguchi, M., Fukatsu, K., et al.[2023]

The novel articulating traction device is designed to enhance the effectiveness of gastric and colonic endoscopic submucosal dissection procedures, potentially improving surgical outcomes.

This device allows for better manipulation and visibility during procedures, which may lead to safer and more efficient removal of lesions in the gastrointestinal tract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel articulating through-the-scope traction device. Simsek, C., Thompson, CC., Alkhateeb, KJ., et al.[2022]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Prospective clinical trial of traction device-assisted endoscopic submucosal dissection of large superficial colorectal tumors using the S-O clip. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Endoscopic Submucosal Dissection Using EndoTrac, a Novel Traction Device. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Use of a novel dual-action traction device to facilitate endoscopic submucosal dissection. [2023]

4. Australia pubmed.ncbi.nlm.nih.gov

Snare combined with endoclips in endoscopic submucosal dissection with mucosal traction for gastroesophageal neoplasia. [2019]

5. Australia pubmed.ncbi.nlm.nih.gov

New traction method (traction ring) for colorectal endoscopic submucosal dissection. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Development and clinical usability of a new traction device "medical ring" for endoscopic submucosal dissection of early gastric cancer. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Multicenter randomized control study of the efficacy of SO clip in colorectal endoscopic submucosal dissection (ESD). (SO clip study in colorectal ESD): Randomized controlled trial. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Novel articulating through-the-scope traction device. [2022]