Magnetic Guided Counetrtraction During Endoscopic Submucosal Dissection
- Conditions
- Early Gastric CancerColon Neoplasia
- Registration Number
- NCT06962293
- Lead Sponsor
- Chinese University of Hong Kong
- Brief Summary
Endoscopic submucosal dissection (ESD) is a technique that allows curative treatment of early gastrointestinal neoplasia with organ preservation. However, it is a technically demanding procedure. Tissue traction plays a vital role in facilitating the visualization of the cutting line and the submucosal vessels, which usually only relies on the hood attached to the tip of the endoscope. However, when dealing with flat or large lesions, the absence of reliable traction in ESD contributes to its technical complexity and prolongs procedure duration. Various traction devices and techniques have been developed to provide tension for the dissection plane and optimal visibility during ESD. Most of these only provide static traction from a fixed angle, thus the effect of traction diminishes when the dissection continues.
In contrast to the aforementioned traction methods, magnetic traction offers the ability to externally manipulate an internal magnetic retractor, simplifying the internal workspace. The proposed magnetic retractor is composed of a detachable clip from an hemoclip is affixed to a magnetic element. By adjusting the position of the external magnetic source, the magnetic retractor automatically couples and aligns with it, enabling simultaneous dynamic directional control during the ongoing ESD operation. A novel robotic magnetic countertraction system was developed (MAG-ESD). The system consists of two sections: an external permanent magnetic source and the disposable magnetic retractor. The external permanent magnetic source is composed by a large external permanent magnet (EPM) which held by robot arm to externally control the locomotion of the magnetic retractor within patient. The disposable magnetic retractor is a consumable surgical instrument that modified from a commercial hemoclip, which has small magnets hangs on the clip legs. The design of the disposable magnetic retractor eliminates the need for endoscope withdrawal which can be inserted through the instrument channel from the handle during ESD operations, like other common instruments. In the current pilot study, the novel MAG-ESD counetrtraction system would be tested in 20 patients who undergo gastric and colonic ESD, with the aim of evaluating the system efficacy and safety.
- Detailed Description
Gastrointestinal (GI) cancers accounted for 39.5 million new cases worldwide in 2020, representing 14.7% of the total new cases of cancer. These cancers also led to 18.8 million deaths, constituting 19% of the total deaths caused by cancer. Typically, endoscopic resection is recommended for early-stage tumors within the GI tract, with endoscopic submucosal dissection (ESD) often utilized for submucosal resection. Tissue traction plays a vital role in facilitating the visualization of the cutting line and the submucosal vessels. However, when dealing with flat or large lesions, the absence of reliable traction in ESD contributes to its technical complexity and prolongs procedure duration.
Various traction devices and techniques have been developed to provide tension for the dissection plane and optimal visibility during ESD. Examples include the "S-O clip" , "Ring thread", "Multiloop", "Double clip and rubber band" , etc. These methods typically involve the deployment of two or more clips to secure both the lesion site and the organ wall. The clips are constrained by springs or strings, allowing for control of the traction direction by deploying new clips to anchor the device at different locations. There is often a need to introduce a new clip through the instrument channel when adjusting the traction direction after the initial clips are anchored. Additional clips must be deployed to manipulate tissue traction, further complicates the internal working space, and inhibits the camera's peripheral vision. The traction achieved is not dynamic. Another drawback is that the traction force weakens during ongoing resection due to the elastic nature of the materials used, especially when the distance between the anchored clips decreases.
In contrast to the aforementioned traction methods, magnetic traction offers the ability to externally manipulate an internal magnetic retractor, simplifying the internal workspace. The proposed magnetic retractor is composed of a detachable clip from an hemoclip is affixed to a magnetic element. By adjusting the position of the external magnetic source, the magnetic retractor automatically couples and aligns with it, enabling simultaneous dynamic directional control during the ongoing ESD operation. Previous research has explored various designs of the magnetic element and external magnetic source. While many magnetic traction methods require withdrawing the endoscope to prepare the deployment of magnetic retractor.
Hence, a novel robotic magnetic countertraction system was developed (MAG-ESD). The system consists of two sections: an external permanent magnetic source and the disposable magnetic retractor. The external permanent magnetic source is composed by a large external permanent magnet (EPM) which held by robot arm to externally control the locomotion of the magnetic retractor within patient. The disposable magnetic retractor is a consumable surgical instrument that modified from a commercial hemoclip, which has small magnets hangs on the clip legs. The design of the disposable magnetic retractor eliminates the need for endoscope withdrawal which can be inserted through the instrument channel from the handle during ESD operations, like other common instruments. Additionally, a robot-assisted external permanent magnetic source can alleviate the workload of surgeons or assistants on controlling the movement of the EPM for the tissue traction inside patients. Robots assist in translating the heavy EPM with speed and low physical demand. An easily controlled magnetic retractor providing consistent traction force could significantly reduce the procedure time and enhance the process of ESD efficiency. The novel system has potential in reducing the procedure time and reducing the workload of endoscopists. The current pilot study aims to confirm the feasibility and safety of using this robotic magnetic countertraction system for MAG-ESD in patients with gastric and colorectal superficial lesions.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- Patient with superficial gastric or colorectal lesions, scheduled for endoscopic submucosal dissection (ESD).
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Patient who refused to participate
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Other cases deemed by the examining physician as unsuitable for safe treatment
The robotic magnetic countertraction system consist of a strong permanent magnet which always have a strong magnetic field in its surrounding. Therefore, we follow the MRI precautions for the strict safety measurement:
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Patient who had a cardiac pacemaker.
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Patient who had any metallic implant or device, such as drug pump, stent, etc.
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Patient who has or had any metal fragments in eye or any other part of body, or had ever worked with metal.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Technical success rate 1 day Successful en-bloc, without major intra-operative adverse event.
- Secondary Outcome Measures
Name Time Method Clinical success rate 30 days pathological R0 resection, without major intra-operative and post-operative adverse event.
MAG-ESD time 1 day Time taken to apply the magnetic traction from introduction of magnetic retractor to the actual countertraction in effect
Lesion size 1day Lesion size
Rate of all intraprocedural adverse event 1 day Intra-procedural adverse event - total
Rate of intraprocedural adverse event - full thickness perforation 1 day Full thickness perforation occurring intra-procedure
Rate of intra-procedural adverse event - haemorrhage 1 day Major bleeding during procedure causing hemodynamic instability, or require blood transfusion, or causing haemoglobin drop \>2g/dL
Rate of intraprocedural adverse event - other 1 day Any other intraprocedural adverse event
Rate of complete resection (R0) 30 days Resection specimen showing complete resection of the target lesion with negative histological horizontal and vertical margins
Total procedure time 1 day Time taken from injection to completion of resection
Lesion location 1 day Location of the lesion in the GI tract
NASA task load index 1 day Endoscopist's NASA-TLX score for the procedure
Overall rate of Post-procedural adverse event 30 days All post procedural adverse event
Rate of Post-procedural adverse event - delayed haemorrhage 30 days Significant bleeding, with blood loss \>2g/dL, or requiring blood transfusion, or causing hemodynamic instability, or requiring re intervention by endoscopy / surgery
Rate of intraprocedural adverse event - partial thickness muscle injury 1 day Partial thickness muscle injury without full thickness perforation
Rate of post-procedural adverse event - delayed perforation 30 days Delayed perforation occurring after completion of procedure
Rate of Post-procedural adverse event - post-ESD coagulation syndrome 30 days Defined by presence of abdominal pain, and fever / leucocytosis after the procedure,
Rate of post-procedural adverse events - others 30 days Any other adverse events after the procedure
Rate of curative resection 30 days Curative resection, defined based on Japanese gastroenterological endoscopy society (JGES) guidelines, depending on the tumor locations (Stomach and colorectal)
Trial Locations
- Locations (1)
Department of Surgery, Faculty of Medicine, the Chinese University of Hong Kong
šš°Hong Kong, Hong Kong