Introduction

Gastric endoscopic submucosal dissection (ESD) is often accompanied by bleeding. Coajet® is a new useful device for hemostasis through monopolar contact and has an injection needle inside. Therefore, this study was conducted to evaluate the effectiveness and safety of a new hemostatic device comparing to hemostatic forceps.

Aims & Methods

This prospective, randomized, single center study has enrolled consecutive patients who were candidates for gastric ESD from Feb. 2022 to Jan. 2023. The Hemograsper® group (HG) had underwent hemostasis by conventional method and the Coajet® (CG) was used for a marking of lesion, submucosal injection in initial stage of ESD and then for hemostasis.

Results

A total 56 patients were enrolled (HG, n = 28, CG, n =28). Baseline characteristics between the two groups showed no significant difference in terms of age, sex, diagnosis, locations, endoscopic sizes, and morphology. The total operation time(minutes, HG 15.97 ± 6.92 vs. CG 12.36 ± 6.73, p = 0.05) and hemostasis time(seconds, HG 186.6 ± 134.5 vs. CG 130.4 ± 81.49, p = 0.06) were shorter when Coajet® was used compared to Hemograsper®. The procedure related other variables such as complete en bloc resection rate, admission days, grade of immediate bleeding, and delayed bleeding within 30days (HG n=1 vs. CG n=1) showed no difference.

Conclusion

A new hemostatic device Coajet® showed comparable efficacy to conventional hemostatic forceps for bleeding control and prevention of delayed bleeding in gastric ESD. Lesser procedure time with Coajet® would be beneficial to both endoscopists and patients.

Introduction

In intraoperative bleeding during endoscopic submucosal dissection (ESD) by using a needle-tip type electrocautery knife, spray coagulation is considered helpful compared to swift coagulation. In this study, we compared the hemostatic effect of two coagulation modes (swift coagulation and spray coagulation) on intraoperative bleeding during gastric ESD in a propensity score analysis.

Aims & Methods

In an intraoperative bleeding strategy, we changed “swift-dependent” hemostasis to “spray-switching” one in 2021. Therefore, 202 bleeding events before April 2020 (33 lesions, Swift group) and 203 bleeding events after April 2022(36 lesions, Spray group) were consecutively collected. In the Swift group, hemostasis was attempted firstly by swift coagulation by using a retracted tip of the needle-type knife, and if hemostasis was not achieved, hemostatic forceps were used. In the Spray group, when hemostasis was attempted several times by swift coagulation but hemostasis was not achieved or when hemostasis was not expected by swift coagulation, spray coagulation was used. If hemostasis was not achieved by spray coagulation, hemostatic forceps were finally used. The two coagulation modes were determined by one endoscopist who retrospective observed the difference of sparks that occurred in hemostasis on video. We performed a post-hoc propensity score-matched analysis to compare the two groups.

Results

In comparison of patient background (age, gender, whether or not intraoperative antithrombotic medication was taken) and lesion background (site of lesion occupation, resection diameter, depth, presence or absence of ulcer, histological type, etc.) between the two groups, the larger number of patients in the Swift group had antithrombotic agents on ESD (p=0.016), while no significant differences were observed in other parameters. A propensity score matching was performed in defining intraoperative administration of antithrombotic agents, location, resection size, pathology, and presence or absence of ulcer as covariates. A total of 106 events were matched per event in the two group, respectively. There was no significant difference in the hemostatic duration per event in the two group (Swift vs. Spray: 48.2 sec. vs. 55.3 sec., p=0.22). The number of coagulations per event in the Swift group was less than that of Spray group (4.3 times vs. 5.8 times, p=0.008). The hemostatic forceps was significantly less frequently used in the Spray group than in the Swift group (31.1% vs. 17.0%, p=0.016). The cumulative success rate of hemostasis with electrocautery knives was likely to be higher in the Spray group (p=0.104), although there was no significant difference between the two groups. In the Swift group, two patients had postoperative hemorrhage and one patient had delayed perforation, whereas no adverse events were observed in the Spray group.

Conclusion

The data suggested that spray coagulation by the tip of the needle-type knife could reduce the use of hemostatic forceps. In gastric ESD, spray coagulation may facilitate the hemostasis of intraoperative bleeding.

Introduction

Endoscopic submucosal dissection (ESD) is widely implemented in Asia. Experience from the western world is still limited, so the evidence on the description of a learning curve (LC) is sparse.

Aims & Methods

The aim of this study is to evaluate the LC for ESD of gastric lesions using accepted proficiency benchmarks (PB).
Retrospective analysis with a prospectively maintained database of all patients undergoing ESD at a Western tertiary center from June 2016 to December 2022.
Inclusion criteria: ESD of gastric lesions performed by a single operator.
Primary endpoint: a LC to estimate the number of ESDs required to achieve PB (>90% for en bloc resection, >80% for histologic margin-negative (R0) resection and resection speeds (RS) >9cm2/hr), using the CUSUM method.

Results

Of 477 ESD performed, a total of 235 ESD met the inclusion criteria.
The en bloc resection rate was 100%. The R0 resection rate was 97% so no statistically significant differences were found, since it was always within PB.
Using the CUSUM method, the LC was divided into learning periods [Phase I - learning phase (cases 1-48); Phase II - adaptation phase (49-72), Phase III - consolidation (from case 73 on).
Globally, after reaching the level of 9cm2/h and after resection 73, the cumulative moving average remains above this speed for all following resections.
Several locations reach moving average proficiency levels at different number of interventions (antrum: from the beginning, body: 134th).

Conclusion

The PB regarding the en bloc and R0 resection were achieved from the beginning.
The PB regarding de RS was achieved from the beginning for the antrum.
The PB regarding de RS, globally, has a clinically significant first learning inflection at ESD number 49 and at ESD number 73 achieved sustained PB for RS.

Disclosure

There are no conflict of interest.

Introduction

Gastric endoscopic submucosal dissection (ESD) has become increasingly popular worldwide as a less invasive curative treatment for early gastric cancer. However, ESD requires highly endoscopic technical skills, and it is important for trainees to develop effective training methods for ESD. ESD training is generally conducted using extracted porcine digestive tracts, but there are several issues regarding ethics, costs, infection, and logistics. In collaboration with KOTOBUKI Medical, we have developed the G-Master, a training model that can simulate ESD in several locations in the stomach. Since G-Master uses plant-derived mucous membrane sheet, there is no contamination and training can be easily performed using endoscope units and devices that are commonly used in clinical practice. Although the G-Master has enabled pre-training before actual ESD at facilities that have adopted it, it is unclear whether it contributes to the improvement of endoscopic technical skills of trainees. In this study, we clarified the usefulness of the G-Master training for inexperienced ESD trainees.

Aims & Methods

The ESD data were collected for the first through fifth gastric ESD cases performed from March 2018 through February 2022 by 15 ESD-inexperienced endoscopists at five participating centers. The ESD data were divided into two groups, one with G-Master training and one without G-Master training and the endpoints were compared retrospectively. The endpoints were procedure speed, perforation rate, operator changing rate, and en bloc resection rate, endoscopists experiences, and clinicopathological features. The resection speed was calculated as the resected area of the specimen divided by the procedure time (mm2/min). The group with G-Master training was defined as the group of trainees who always had at least one ESD training session with G-Master before each ESD. The group without G-Master training was defined as the group of trainees who had never done G-Master ESD training.

Results

A total of 75 gastric ESD cases were enrolled, with 25 cases in the group with G-Master training performed by 5 ESD-inexperienced endoscopists and 50 cases in the group without G-Master training performed by 10 ESD-inexperienced endoscopists. There was no difference between the two groups in endoscopists experiences including the years after graduation from medical school, the number of esophagogastroduodenoscopies and colonoscopies performed, and clinical features of gastric ESD cases including the location or size. In the group with G-Master training, the median procedure speed for all cases was significantly faster (with vs without G-Master: 13.1 mm2/min vs. 8.1 mm2/min, p>0.001). And the procedure speed of the training group was linearly improved from the initial to the last cases (with vs without G-Master: initial case; 11.8 mm2/min vs 8.5 mm2/min, last case; 23.1 mm2/min vs 12.0 mm2/min). Additionally, the rates of perforation (0 case (0%) vs 1 case (2%)) and operator change to expert (5 cases (20%) vs 15 cases (30%)) were lower. There was no difference in en bloc resection rate between the two groups.

Conclusion

It was suggested that performing G-Master training before actual ESD could improve the endoscopic technical skills of trainees who are inexperienced in ESD.

Introduction

In superficial gastric tumors, endoscopic submucosal dissection (ESD) has become the standard of care, and the treatmenttechnique and strategy have been matured. On the other hand, the number of cases performed by trainees as anintroduction to ESD is increasing, and the types and handling of antithrombotic drugs are also changing.

Aims & Methods

On these backgrounds, we examined the transitions to clarify how the treatment outcomes and adverse events of gastric ESD have changed.
From 2014 to 2022, 565 patients of superficial gastric neoplasms who underwent ESD were divided into two groups: the first half (n=435) from 2014 to 2020 and the second half (n=130) from 2021 to 2022, where the number of trainees significantly increased. Treatment outcomes (En bloc resection rate, curability, procedure time, inflammatory response)and adverse events (perforation, postoperative bleeding, postoperative pneumonia, and pyrexia for unknown reasons) were retrospectively compared between two groups, using the propensity score matching analysis. Regarding oral antithrombotic agents, antithrombotic drugs were continued, DOAC stopped only 24 hours before treatment, and warfarin was continued after INR value was controlled at <3.0.

Results

Propensity score matching yielded 130 pairs. Trainee's involvement was 29.7% in the first half and 61.4% in the second half. The comparison demonstrated a significant difference for the following outcomes: curability was 86% in the first half and 90.1% in the second half (P=0.028), the CRP mean [SD] was 1.32 [2.14] in the first half and 0.82 [0.97] in the second half (P=0.032), and postoperative bleeding rate was 5.9% in the first half and 0.0% in the second half (P=0.013). Others were similar values for outcomes.

Conclusion

Even with the increased involvement of trainees, treatment outcomes have not chronologically exacerbated. Additionally, inflammatory response and postoperative bleeding have improved. These results suggest that safe and secure gastric ESD can be performed by appropriate technique and strategy under supervise of experts.

Introduction

Endoscopic submucosal dissection (ESD) is increasingly being used as a minimally invasive treatment option for early gastric cancer (EGC), with a very low risk of lymph node metastasis.

Aims & Methods

This study aimed to evaluate the short-, medium-, and long-term clinical outcomes of patients undergoing gastric ESD at a tertiary hospital center. Patients undergoing ESD for superficial gastric lesions (SGLs) between September 2015 and January 2023 were prospectively evaluated. Demographic, clinical (comorbidities, medication, and relevant family history), endoscopic (location, size, and morphology of the lesion, resection scar evaluation), and pathological data (from the resected specimen, mapping biopsies, and scar biopsies) were collected.

Results

Since 2015, 195 patients with SGLs (mean age 70.7±9.8 years, 58.6% male) underwent ESD, with a median follow-up time of 28 months (interquartile range 13-54). Most patients presented with intestinal metaplasia only in the antrum (n=72) or in the antrum and corpus (n=60), and the most frequent location of SGLs was the antrum (64.6%). Resection was R0 in 95.4% of cases and curative in 87.7% (only one non-curative case had no free horizontal margins). During the follow-up period, 15 metachronous lesions and 8 recurrences were identified, on average 24.1±3.4 months after the index procedure. It should be noted that most recurrences (n=5) were identified at the 36- and 48-month reevaluation endoscopies. The complication rate was 3.6%, corresponding to 3 intra-procedural perforations (2 treated endoscopically) and 4 cases of significant bleeding after the procedure were registered.

Conclusion

Endoscopic submucosal dissection is safe and effective, with a high cure rate and low complication and recurrence rates. The identification of mostly late recurrences suggests the need to develop risk assessment tools that allow for defining personalized follow-up intervals.

Introduction

Endoscopic submucosal dissection (ESD) is widely implemented in Asia. BEST J-score is a clinically useful prediction model validated in 2021, based on this population, to stratify the risk of delayed bleeding (DB) after gastric ESD. Experience from the Western world is still scarce.

Aims & Methods

The aim of our study is to validate BEST-J score in a Western sample.
Retrospective analysis with a prospectively maintained database of all patients undergoing ESD at a Western tertiary center from June 2016 to December 2022.
Gastric ESD performed by a single operator were included in this study. BEST-J score was applied for all procedures, which comprised 10 variables (intake of warfarin, direct oral anticoagulant (DOAC), chronic kidney disease with haemodialysis, intake of P2Y12 receptor antagonist, aspirin, cilostazol, tumour size >30 mm, lower-third in tumour location, presence of multiple tumours and interruption of each kind of antithrombotic agents). The primary endpoint was to validate BEST-J score accuracy in predicting DB (up to 28 days after ESD).

Results

Of 477 ESD performed, a total of 252 ESD met the inclusion criteria; 56.5% were male, with a mean age of 68 years (SD 8 years). Of this, 30 patients (15.3%) were under anticoagulant therapy, 19 of them (63.3%) with DOAC. Antiplatelet agents were taken by 48 patients (19%). From these, 5 (2.0%) presented DB following ESD, with a median time to bleeding of 11 days.
According to BEST-J score, bleeding risk was low (0-1 points) in 205 procedures (81,3%), intermediate (2 points) in 18 (7.1%), high (3-4 points) in 26 (10.3%) and very high (≥5 points) in 3 (1.2%).
BEST-J score presented an acceptable accuracy predicting DB in our sample, with an AUC=0.777 (p=0.034, CI 95%, 0.58-0.975). The optimal cut-off value to predict DB was a BEST-J score ≥ 3, which matches the cut-off value for high-risk of bleeding in the original investigation. This value had a sensitivity of 60.0%, specificity of 88.7% and a negative predictive value of 99.1%.

Conclusion

The BEST-J score presents an acceptable accuracy for post-ESD bleeding and it is particularly useful in identifying low risk DB patients. Therefore, this model is a good clinical decision-making support tool in the Western population.