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Evaluation of utility and safety of endoscopic submucosal dissection using multi loop traction device for early colorectal cancer-single center prospective observational study-

ABSTRACT: Primary outcome(s): Endoscopic findings (visual type, localization, size) Details of the endoscopic treatment (operator, ESD knife, contents of the injection solution, treatment time) Adverse event

DISEASE(S): Early Colorectal Cancer

PROVIDER: 2724614 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Efficacy and Safety of Multi Loop Traction Device-assisted Colorectal Endoscopic Submucosal Dissection: A Multicenter, Randomized Clinical Trial

Project description:Interventions: 1) MLTD-ESD group Colorectal endoscopic submucosal dissection (ESD) is performed using the Multi Loop Traction Device (MLTD). The number of MLTD used in a single session is not limited. The conversion of the allocated therapeutic method is permitted. If the MLTD is ineffective for more than 10 minutes, the MLTD can be removed. 2) Conventional ESD group ESD is completed using a standard therapeutic strategy that does not involve the use of traction devices. The conversion of the allocated therapeutic method is permitted. The MLTD can be used if the endoscopist determines that the traction device has been required for more than 10 minutes. Primary outcome(s): Dissection speed (area resected [mm^2]/duration in minutes) Study Design: Parallel Randomized

| 2724553 | ecrin-mdr-crc

Triple-loop clip for the traction-assisted colorectal endoscopic submucosal dissection: multidirectional triple-loop traction method.

Project description: Not available

| S-EPMC7806497 | biostudies-literature

Multi-loop traction device facilitates gastric endoscopic submucosal dissection: ex vivo pilot study and an inaugural clinical experience.

Project description:BackgroundEndoscopic submucosal dissection (ESD) is technically difficult and requires considerable training. The authors have developed a multi-loop traction device (MLTD), a new traction device that offers easy attachment and detachment. We aimed to evaluate the utility of MLTD in ESD.MethodsThis ex vivo pilot study was a prospective, block-randomized, comparative study of a porcine stomach model. Twenty-four lesions were assigned to a group that undertook ESD using the MLTD (M-ESD group) and a group that undertook conventional ESD (C-ESD group) to compare the speed of submucosal dissection. In addition, the data of consecutive 10 patients with eleven gastric lesions was collected using electronic medical records to clarify the inaugural clinical outcomes of gastric ESD using MLTD.ResultsThe median (interquartile range) speed of submucosal dissection in the M-ESD and C-ESD groups were 141.5 (60.9-177.6) mm2/min and 35.5 (20.8-52.3) mm2/min, respectively; submucosal dissection was significantly faster in the M-ESD group (p < 0.05). The rate of en bloc resection and R0 resection was 100% in both groups, and there were no perforation in either group. The MLTD attachment time was 2.5 ± 0.9 min and the MLTD extraction time was 1.0 ± 1.1 min. Clinical outcomes of MLTD in gastric ESD were almost the same as those of ex vivo pilot study.ConclusionsMLTD increased the speed of submucosal dissection in ESD and was similarly effective when used by expert and trainee endoscopists without perforation. MLTD can potentially ensure a safer and faster ESD.

| S-EPMC8740506 | biostudies-literature

Endoscopic submucosal dissection by using a new traction device.

Project description:Video 1Patient with a history of gastric ectopic pancreas and epigastric pain. We illustrate the endoscopic submucosal dissection of the ectopic pancreas using a new traction device, the ProdiGi traction wire. Using this device, we were able to resect the lesion en bloc with no adverse events.

| S-EPMC8645833 | biostudies-literature

A Lasso-Loop Traction Technique for Arthroscopic Superior Capsular Reconstruction.

Project description:Irreparable rotator cuff tears (RCTs) cause shoulder pain and disfunction. Management of RCT patients has classically been difficult due to few treatment options. Since Mihata et al. in 2013 introduced the superior capsular reconstruction (SCR) technique as a treatment option, it has become widespread among surgeons, especially for young active patients in whom reverse shoulder arthroplasty is not recommended. With SCR, a reduced humeral head can be maintained and superior displacement is avoided, improving shoulder pain and restoring active shoulder motion. A variety of grafts may be used, but the surgery can be technically complicated. An arthroscopic lasso-loop traction technique for SCR is described here, which simplifies graft shoulder reduction by traction from the anteromedial and posteromedial portals.

| S-EPMC7528755 | biostudies-literature

A study to evaluate the usefulness of traction-assisted endoscopic submucosal dissection using a newly developed all-in-one device used to resect colorectal polyps: a Multicenter Randomized Controlled Trial

Project description:Interventions: Procedure/Surgery : 1) onestep knife conventional ESD (control) ? Insert the colonoscope with the transparent cap attached. ? After puncturing the submucosal layer immediately around the lesion with a puncture needle for submucosal solution injection, inject the saline-based submucosal solution. ? When the lesion is sufficiently raised, submucosal dissection is performed using a dual knife. ? Retrieve the resected specimen, fix it on a styrofoam fixing plate, and ask the pathology department for tissue analysis. (2) onestep knife + Traction ESD (intermediate group) ? Insert the colonoscope with the transparent cap attached. ? After puncturing the submucosal layer immediately around the lesion with a puncture needle for submucosal solution injection, inject the saline-based submucosal solution. ? When the lesion is sufficiently raised, submucosal dissection is performed using a dual knife. ? When performing ESD, make an incision around the lesion. After fixing the rubber band to the endoscope clip from the outside of the patient, insert it into the channel of the colonoscope and fix the clip at the end of the pre-incision lesion using the clip. Using the second clip, hold the rubber band secured to the pre-fastened first clip and secure the clip in a position that will provide adequate traction. ? Implement additional ESD. ? Retrieve the resected specimen and fix it on a styrofoam fixing plate, and then ask the pathology department for tissue analysis Primary outcome(s): procedure time; resection speed Primary Purpose : Treatment, Intervention Model : Parallel, Blinding/Masking : Single, Blinding Target : Subject, Allocation : RCT

| 2514694 | ecrin-mdr-crc

The efficacy and safety of Multi Loop Traction Device for colorectal ESD: a single center randomized control trial

Project description:Interventions: normal colorectal ESD colorectal ESD with MLTD Primary outcome(s): resection time (from the start of resection to the end of resection) Study Design: Parallel Randomized

| 2661025 | ecrin-mdr-crc

Device selection trial in endoscopic submucosal dissection for colorectal epitherial neoplasms: A randomized controlled open trial.

Project description:Interventions: Flex knife group Flush knife group Primary outcome(s): Procedure time Study Design: Parallel Randomized

| 2616795 | ecrin-mdr-crc

Improved limb positioning and hip access during hip arthroscopy with articulated traction device.

Project description:Surgeons use hip arthroscopy to address intra-articular pathology of the hip. To access the central compartment, traction must be applied to the leg. Various types of equipment and techniques have been used, but many have limitations. Improved ability to assess the offending pathology is achieved with improved ability to move the hip joint in space during surgery. Dynamic assessment of femoroacetabular impingement allows the surgeon to gauge the adequacy of resection. We describe the use of an articulated traction device that allows complete surgeon control over the leg position, as well as the freedom to place the leg in virtually any position with ease, unencumbered by the mechanics of a standard traction table. This device provides the surgeon with an improved ability to dynamically assess the hip and removes some of the responsibility of the operating room staff for intraoperative leg positioning.

| S-EPMC3691775 | biostudies-literature

Safety and Efficacy of an Atraumatic Uterine Cervical Traction Device: A Pilot Study.

Project description:Introduction: Alignment of the uterine cervix with the vaginal canal is often required during insertion of an intrauterine contraceptive device (IUD). Currently available instruments are traumatic tenacula, which can cause pain and bleeding and represent an obstacle for certain patients to pursue their medical follow-up. A novel investigational cervical vacuum tenaculum, enables atraumatic traction of the cervix using a semi-circular suction pad, designed to conform to the anatomical shape of the external cervical os. Suction is generated by manually pulling out a sliding tube in a vacuum chamber. Methods: We performed a single arm non-comparative pilot study to assess the safety and efficacy of the cervical vacuum tenaculum in 13 women receiving an IUD. Data on procedural efficacy, safety, patient-reported pain scores at specific time points during IUD insertion procedure and patient satisfaction were collected prospectively. Results: Insertion of IUD was successful with use of the study device in 7 of the 13 enrolled patients (54%). No bleeding or only limited ecchymosis were caused by the device. No adverse events were reported. Participants reported very little pain (mean Visual Analog Scale <10) when applying the device. Participants who achieved IUD insertion with the device reported strong overall satisfaction with the procedure. Conclusions: The suction-based atraumatic tenaculum can be used to manipulate the cervix during IUD insertion with satisfactory efficacy and safety. The results of this pilot study support further studies of this device in larger populations comparing with standard single-tooth tenaculum. Clinical Trial Registration: ClinicalTrials.gov, identifier: NCT04441333.

| S-EPMC8732360 | biostudies-literature

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