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The goal of this clinical trial is to investigate whether the flexible auxiliary single-arm transluminal endoscopic robot (FASTER) system can improve the safety of the endoscopic submucosal dissection (ESD). It will also evaluate the efficacy of the system, such as whether it could reduce the procedure time and so on. The main questions it aims to answer are:
Does the use of the FASTER system reduce the number of muscular injuries, improving the safety of the ESD procedure? Does the use of the FASTER system reduce the procedure and dissection time, improving the efficacy of the ESD procedure? Researchers will compare FASTER-assisted ESD and conventional ESD to evaluate the safety and efficacy of the FASTER system.
Participants will:
Be randomly assigned to the group with ESD using the traditional procedure or to the group with ESD assisted by the FASTER system.
Keep a diary of their symptoms after the procedure. ESD has gained widespread acceptance as the standard method for treating early-stage gastrointestinal cancers. Adequate exposure of the submucosa layer through effective tissue traction is vital for the safe and effective performance of ESD. The FASTER system is designed to overcome this technical difficulty.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FASTER-assisted ESD group | Experimental | Patients in this group undergo ESD with the assistance of the FASTER system. |
|
| Conventional ESD group | Active Comparator | Patients in this group undergo ESD following the clinically established pattern. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FASTER-assisted ESD | Procedure | The patients who are randomly assigned to the FASTER-assisted ESD group will undergo the ESD procedure with the assistance of the FASTER system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| the number of muscular injuries | Muscular injury is described as visible damage to the muscularis propria. | Within 24 hours after the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| the incidence of muscular injury | Muscular injury is described as visible damage to the muscularis propria. | Within 24 hours after the procedure. |
| the frequency of intraoperative hemorrhage | Within 24 hours after the procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiuli Zuo Professor, MD, PhD | Contact | 86+18560080066 | zuoxiuli@sdu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | 250012 | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Conventional ESD | Procedure | The patients who are randomly assigned to the conventional ESD group will undergo the ESD following the clinically established pattern. |
|
| the proportion of intraoperative hemorrhage ≥ grade 2 | Intraoperative hemorrhage is divided into four grades: Grade 0 means no significant bleeding is observed during the procedure. Grade 1 means minimal bleeding, which could stop spontaneously or be easily controlled by cauterization with a dual knife. Grade 2 refers to minor hemorrhage that requires multiple cauterizations with a dual knife or hemostatic forceps. Grade 3 indicates massive hemorrhage that requires multiple cauterizations with hemostatic forceps. | Within 24 hours after the procedure. |
| hemostasis time | Hemostasis time referred to the time from the detection of submucosal bleeding until hemostasis was completed. | Within 24 hours after the procedure. |
| the frequency of supplemental injections | Supplemental injection refers to injections performed after the beginning of the dissection. | Within 24 hours after the procedure. |
| the supplemental injections time | The time of supplementary injection is from the insertion of the injection needle into the submucosal layer until the injection is completed and the needle is withdrawn. | Within 24 hours after the procedure. |
| procedure time | Procedure time is the time from the beginning of injection to the completion of dissection. | Within 24 hours after the procedure. |
| dissection time | Dissection time is the time from the beginning of dissection to the completion of dissection. | Within 24 hours after the procedure. |
| direct-vision dissection rate | Direct-vision dissection time is the time that the endoscopist can directly observe the tip of the dual knife and the submucosal layer at the same time. By dividing the direct-vision dissection time by the total dissection duration, the direct-vision dissection rate is calculated. | Within 24 hours after the procedure. |
| en bloc resection rate | En bloc dissection refers to the complete removal of the entire lesion in a single piece. | Within 24 hours after the procedure. |
| R0 resection rate | R0 resection is defined as en bloc resection with negative vertical and horizontal margins. | Within 24 hours after the procedure. |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |