Effectiveness of a multi-loop traction gadget for colorectal endoscopic submucosal dissection carried out by trainees: a pilot examine

Research design and moral statements

This was a retrospective cohort examine carried out on the Saitama Medical College Worldwide Medical Middle in Japan. It was accredited by the Institutional Assessment Board of Saitama Medical College Worldwide Medical Middle (institutional ID: 20-202) and carried out in accordance with the ideas of the Declaration of Helsinki. We obtained knowledgeable consent from all sufferers earlier than their inclusion on this examine.

Sufferers

We included 26 consecutive sufferers who underwent colorectal ESD at our hospital between October and December 2021. All procedures have been carried out in response to the 2019 Japanese Society for Most cancers of the Colon and Rectum (JSCCR) tips for the remedy of colorectal most cancers13 for sufferers with a preoperative endoscopic or pathologic prognosis of early colorectal most cancers.

Trainees and specialists

Two trainees and three specialists participated within the examine. The trainees had expertise performing fewer than ten higher gastrointestinal ESD procedures and had no expertise performing colorectal ESD. The specialists had expertise performing greater than 200 gastrointestinal ESD procedures. Each the trainees and specialists have been physicians at our hospital.

Definitions of the MLTD group and the management group

The MLTD group included sufferers who underwent colorectal ESD with the MLTD carried out by the 2 trainees. The management group included sufferers who underwent colorectal ESD with out the MLTD carried out by the three specialists.

Colorectal ESD setting

We carried out colorectal ESD within the endoscopy room beneath intravenous anesthesia utilizing midazolam and pethidine. Scopolamine was used as an antispasmodic drug; nonetheless, glucagon was substituted in sufferers with cardiac illness or benign prostatic hyperplasia. All ESD procedures have been carried out utilizing therapeutic endoscopes (PCF-H290ZI or GIF-H290T; Olympus, Medical Techniques Co., Tokyo, Japan) with a clear cap (Olympus). Usually, PCF-H290ZI is used for colorectal ESD and GIF-H290T is usually used for rectal lesions. We used a 1.5-mm DualKnife J (KD655Q; Olympus) to carry out the mucosal incision or submucosal dissection. Utilizing an electrosurgical generator (VIO 3; ERBE Elektromedizin, Tübingen, Germany), the endoCUT I mode (impact 1 or 2, period 2, interval 2) was used for the mucosal incision, pressured coagulation (impact 4.5 or 6.1) was used for the submucosal dissection, and spray coagulation (impact 1.2) was used for hemostasis. To raise the submucosa, a neighborhood injection of 0.4% sodium hyaluronate (MucoUp®; Boston Scientific, Tokyo, Japan) and a small quantity of indigo carmine have been administered.

Methods for performing colorectal ESD utilizing the MLTD

Step 1: Earlier than or after the total circumferential mucosal incision was carried out across the lesion (Fig. 1a), we connected the MLTD to the mucosal edge for elevation (Fig. 1b). The MLTD was connected to both the lesion or the traditional mucosa, contralateral to the lesion. As a precaution, sufficient MucoUp® was injected into the submucosa on the website of the MLTD attachment to keep away from traction on the muscle layer.

Determine 1

Methods used for colorectal endoscopic submucosal dissection (ESD) utilizing the multi-loop traction gadget (MLTD). (a) Full circumferential mucosal incision across the lesion. (b) Attaching the MLTD on the mucosal edge to raise it. (c) The visible discipline of the submucosa and muscle layer is nice, permitting for secure submucosal dissection. (d) En bloc resection of the lesion was profitable and with out intraoperative problems.

Step 2: The route, distance, and gravity ought to be checked completely earlier than attaching the MLTD as a result of the traction impact depends upon the MLTD attachment website.

Step 3: After attaching the MLTD, a superb visible discipline of the submucosa was obtained, and the submucosa was dissected safely and simply (Fig. 1c, d). When the traction impact was insufficient, extra traction was offered utilizing the outlet within the center (Fig. 2a, b) or a brand new MLTD was ready.

Determine 2
figure 2

Further traction. (a) When the traction impact was insufficient, extra traction was utilized utilizing the outlet within the center (yellow arrow). (b) After extra traction.

Step 4: After lesion resection, we eliminated the MLTD with a biopsy forceps and picked up the lesion.

Benefits of the MLTD

There are a number of traction strategies for colorectal ESD, together with the usage of the S – O clip14ring-shaped thread traction15and the cross-counter approach16. If the S – O clip or ring-shaped thread traction is used, then the traction could weaken because the submucosal dissection progresses, and extra units could also be required. With the cross-counter approach, the traction pressure may be adjusted to some extent, however a balloon-type overtube is required. In comparison with these traction strategies, the MLTD has the next 5 benefits: it’s simple to arrange; it may be connected with atypical rotary clip units with out the necessity for added specialised units; it permits the flexibility to ship by the scope to the surgical discipline; extra traction is feasible utilizing the intermediate loop and the traction route may be adjusted; and it’s simple to chop it with biopsy forceps.

Definitions

Throughout this examine, process time was outlined because the time from the preliminary mucosal incision to the tumor resection. Dissection velocity was calculated utilizing the next equation: largest diameter of the resected specimen (mm) / 2 × smallest diameter of the resected specimen (mm) / 2 × 3.14 / process time (minutes). Intraoperative perforation was outlined as perforation throughout ESD. The midazolam dose was outlined as the whole quantity of midazolam used throughout ESD. The MucoUp® dose was outlined as the whole quantity of MucoUp® used throughout ESD. Specimen harm was outlined as any harm to the specimen throughout ESD, together with that brought on by traction. Endoscopic block resection was outlined as resection of 1 piece that included the entire tumor. Tumor resectability was evaluated based mostly on its ultimate pathology. Intraoperative bleeding was outlined as bleeding that would not be handled by endoscopic hemostasis throughout ESD. Delayed perforation was outlined as a perforation recognized by computed tomography after ESD. Delayed bleeding was outlined as hemorrhaging that required endoscopic hemostasis after ESD. Instances that required surgical procedure due to ESD-related problems have been outlined as surgical procedure on account of antagonistic occasions. Concerning maneuverability, three professional endoscopists with expertise performing greater than 200 gastrointestinal ESD procedures divided the instances into two teams (good / regular or poor) based mostly on the tumor location and intestinal peristalsis.

Statistical evaluation

We in contrast the remedy outcomes of the MLTD group (two trainees) and people of the management group (three specialists). The first examine final result was the process time. The secondary outcomes have been dissection velocity and intraoperative perforation. Adjunctive outcomes have been the midazolam dose, MucoUp® dose, maneuverability, specimen harm, en bloc resection, resectability, resected tumor measurement, largest diameter of the resected specimen, smallest diameter of the resected specimen, ultimate pathology, intraoperative bleeding, delayed perforation, delayed bleeding, surgical procedure on account of antagonistic occasions, and recurrence. In each teams, binary variables have been evaluated utilizing Pearson’s chi-square take a look at, and steady variables have been evaluated utilizing the Mann – Whitney U take a look at or Pupil’s t-test. All analyzes have been carried out utilizing STATA® model 17 (StataCorp, Faculty Station, TX, USA), and statistical significance was set at p <0.05.

Knowledgeable affected person consent assertion

Knowledgeable consent was obtained from all sufferers who participated on this examine.

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