Introduction

Submucosal lifting agent is critical to perform endoscopic submucosal dissection (ESD) and even used sometimes in conventional endoscopic mucosal resection (EMR). ORISE Gel is a recently introduced and approved lifting agent in United States and Europe and one of the most used injection solutions for ESD. However, it has recently been revealed in some cases that ORISE Gel induces a foreign body reaction histologically. Most publications have been reported as case series from United States, but few from other countries. We aim to analyze the characteristic findings and clinical implications with Orise Gel injection and literature review to increase awareness.

Aims & Methods

We used a prospectively maintained ESD database at our center in Sweden between January 2020 and March 2023. Colorectal ESD or converted EMR during ESD (rescue EMR) specimens injecting ORISE Gel were included. The literature review included from PubMed between January 2019 to March 2023.

Results

A total of 99 cases (89 ESD or rescue EMR and 10 subsequent surgeries) were identified during the study period. There are 48 male and 51 female patients with a median age of 69.4 years.
Orise gel injection was used in 57 cases (57.6%). 8 cases had radiological follow-up because of T1 cancer. Of these, 5 cases underwent subsequent surgical resections, where the injection sites were in distal rectum in 3, cecum in 1 and descending colon in 1 case. The surgical resection specimens showed histopathologically T2 colorectal cancer in one, residual adenoma with low grade dysplasia in 2, and no dysplasia cell in 2 cases. All of them showed histologically extensive foreign body-type granulomatous giant cell reaction. These changes were detected in 3 cases by MRI or CT image with a sign of local wall thickness before surgical resections. This resulted in a clinical overdiagnosis of more advanced T-staging. Meanwhile, 3 cases were followed up by radiological imaging and 2 of them showed a similar change as local wall thickness, however both were diminished as time advanced.

Conclusion

This large Swedish case series raises the awareness that the submucosal lifting agent causes extensive histological reaction at the injection site in all surgical specimens. These changes are observed at the radiological follow-up. This gel deposits in the specimens may lead to a misinterpretation of a mass as tumor growth and they can change differently with time.

Introduction

Traction strategies are increasingly becoming the standard approach for endoscopic submucosal dissection (ESD). 'Natural' traction forces, such as gravity, remain valuable during ESD, helping to optimize dissection and improve procedural speed. However, mechanical traction, particularly the adaptive traction strategy, has recently shown promising results in terms of efficacy and safety, including the highest resection speeds reported in the literature for colorectal ESD (1,2).
The aim of our study was to evaluate resection speed based on initial gravitational force in a prospective cohort of patients undergoing colorectal ESD with adaptive traction strategy.

Aims & Methods

Consecutive patients undergoing ESD of conventional colorectal lesions with an adaptive traction strategy at a tertiary referral center between 2023 and 2025 were prospectively enrolled. The initial gravity was classified as favorable/neutral and unfavorable. The primary endpoint was resection speed. A non-inferiority analysis was conducted for the primary endpoint, with the non-inferiority margin set at a 20% reduction in resection speed. Secondary endpoints included the rate of En Bloc resection, the rate of R0 resection and the rate of adverse events.

Results

The study included 118 patients, of whom 78 (66%) had favorable or moderate initial lesion severity and 40 (34%) had unfavorable initial gravity. The mean resection speed in the favorable and moderate gravity group was 37.4 versus 35.8 (p = 0.6067) in the unfavorable group, the R0 resection rate was 86.2% versus 86.8% (p > 0.99), and the perforation rate was 5.9% versus 7.0% (p = 0.7015).
After adjustment for lesion location, operator and lesion area, the resection rate in the unfavorable severity group was very close to the non-inferiority margin (p = 0.07).

Conclusion

In our cohort of patients undergoing colorectal ESD using an adaptive traction strategy, initial gravity did not alter the speed and quality of resection. We can assume that the use of a mechanical adaptive traction strategy allows overcoming the need for the natural traction force provided by gravity, thus avoiding the need to mobilize patients during the procedure to achieve a more favorable gravitational force.

References

(1) Grimaldi J, Masgnaux LJ, Lafeuille P, et al. Endoscopic submucosal dissection with adaptive traction strategy: first prospective multicenter study (with video). Gastrointest Endosc. 2024 Sep;100(3):517-523.
(2) Masgnaux LJ, Grimaldi J, Rivory J, et al. Endoscopic submucosal dissection assisted by adaptive traction: results of the first 54 procedures. Endoscopy. 2024 Mar;56(3):205-211

Disclosure

Jean Grimaldi, Louis-Jean Masgnaux, Romain Legros, Jérome Rivory, Timothée Wallenhorst, Jérémie Jacques and Mathieu Pioche are co-founder of Atract Device & Co.
The other authors have no competing interests related to this study.

Introduction

Endoscopic submucosal dissection (ESD) is gaining popularity around the word. However, ESD remains a technically difficult, labor-intensive and time-consuming procedure.

Aims & Methods

Study aim: To describe first clinical experience with recently developed new endoscopic platform to facilitate ESD.
Methods: C¹ endoscopic platform (Lumendi LLC, Westport, CT, USA) is a flexible overtube with a balloon on its distal end and attached instrument channel. The C¹ was preloaded on top of any colonoscope and inserted into colon till pre-cancerous or early cancerous lesion is reached. After circumferential incision around the lesion was completed with a commercially available ESD knife, a specially designed flexible grasper (Lumendi LLC, Westport CT, USA) was advanced through the instrument channel. The separated edge of the lesion was grasped with the grasper to facilitate ESD. After completion of the ESD, C¹ was used a conduit to deliver Overstitch endoscopic suturing device mounted on a double channel upper endoscope (GiF 2T180, Olympus, Center Valley, PA, USA) to the site of lesion removal to perform sutured closure of the post-ESD defect.

Results

C¹ platform was used in 7 patients (3 females, 4 males, age 62.1±10.1 years) with large (35.0±13.5 mm) sessile colonic polyps. Most lesions were located in anatomically difficult positions (splenic and hepatic flexure, appendix and ileocecal valve). On-demand inflation of the C¹ balloon facilitated advancement of the colonoscope through the colon and shortening and straightening of the colonic turns. None of the patients required external pressure or a change of patient position and in all cases the colonoscope was successfully advanced to the cecum. When the lesion was reached, the balloon was distended providing stabilization of the colonoscope during ESD. Flexible grasper provided multidirectional dynamic retraction of the lesion making endoscopic dissection simple and fast (total ESD time 38.7±16.5 minutes with mean dissection speed 24.8 mm²/minute). After completion of dissection, the lesion was retrieved through C¹ and then Overstitch suturing device was easily delivered to the ESD site. Suturing closure of post-ESD defects was successfully achieved in all patients. There were no device related adverse events during the study.

Conclusion

Newly developed C¹ endoscopic platform with a flexible grasper significantly facilitates colonic ESD.

Introduction

Colorectal endoscopic submucosal dissection (ESD) has become a widely used endoscopic technique for superficial colorectal tumors resection. ESD has a higher en bloc resection rate particularly for large lesions than endoscopic mucosal resection (EMR). Thus, ESD is associated with a better curability and can facilitate an adequate histological evaluation. However, the high incidence of postoperative adverse events, such as delayed bleeding, delayed perforation, and post-ESD electrocoagulation syndrome (PECS), which are associated with larger mucosal defects after ESD, has been a cause of concern. Recent meta-analyses have reported that the incidence of postoperative adverse events after ESD was higher than that after EMR.¹ Therefore, these events should be controlled. Various closure techniques have been used to close larger mucosal defects in ESD.² However, the efficacy of these closure techniques in preventing adverse events remains controversial. Furthermore, few studies have been conducted to evaluate a single closure technique with a substantial number of cases.
In some cases, closure of mucosal defects after colorectal ESD is performed using a double-layered suturing technique with conventional hemostatic clips.³ In this technique, the muscle layer is first grasped directly with clips and tented inward, and then the mucosal layer is closed. Therefore, this technique has the potential to provide more reliable closure and prevent the spread of inflammation and abdominal pain than methods that merely close the mucosal layer.

Aims & Methods

This study retrospectively evaluated the impact of closure using a double-layered suturing technique on postoperative adverse events.
In total, 370 lesions in 317 patients who underwent colorectal ESD were included in this analysis. Then, patients with 197 lesions that were completely closed were assigned to the closure group. Meanwhile, patients with 173 lesions including 55 that were partially closed and 118 that were not closed were assigned to the non-closure group. Propensity score matching was performed and 136 lesions were selected for each group.

Results

The closure group had a significantly lower overall incidence rate of postoperative adverse events including delayed bleeding, delayed perforation and post-ESD electrocoagulation syndrome than the non-closure group (2.2% vs. 9.6%, p = 0.018). The closure group had a significantly lower incidence of abdominal pain on the day after ESD than the non-closure group (2.9% vs. 11.0%, p = 0.015).

Conclusion

Prophylactic closure of mucosal defects after colorectal ESD using a double-layered suturing technique could prevent postoperative adverse events and abdominal pain on the day after ESD.

References

1 Wang N, Shu L, Liu S, et al. Comparing endoscopic mucosal resection with endoscopic submucosal dissection in colorectal adenoma and tumors: Meta-analysis and system review. PLoS One 2023;18:e0291916.
2 Kobara H, Tada N, Fujihara S, Nishiyama N, Masaki T. Clinical and technical outcomes of endoscopic closure of postendoscopic submucosal dissection defects: Literature review over one decade. Dig Endosc 2023;35:216-231.
3 Tanaka S, Toyonaga T, Obata D, Ishida T, Morita Y, Azuma T. Endoscopic double-layered suturing: a novel technique for closure of large mucosal defects after endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD). Endoscopy 2012;44 Suppl 2 UCTN:E153-154.

Introduction

Endoscopic submucosal dissection (ESD) is a highly effective and safe technique for the resection of superficial colorectal neoplasms, but it can still be technically challenging for lesions in contact with or invading the appendiceal orifice. Until recently, appendicular lesions were considered unresectable or difficult to resect by endoscopy because of the high risk of incomplete resection, perforation or acute appendicitis. Small studies have reported ESD feasibility and efficacy in this particular context, including for lesions deeply invading the appendix. However, strong data about these more complex resections is lacking and the best management strategy for this kind of lesion remains a matter of debate, with upfront surgery still being the first-choice treatment in most western countries.

Aims & Methods

With the present study, we aimed to assess and report the outcomes of ESD for the treatment of lesions in contact with or invading the appendiceal orifice. We prospectively collected data of ESD procedures for appendiceal neoplasia in a multicenter prospective register. En Bloc R0 resection rate was the primary outcome. Morbidity and additional surgery were also reported.

Results

A total of 112 patients were included, comprising 47 (42%) with previous appendectomy. Fifty-six lesions (50%) were type 3 according to Toyonaga classification (15 (13.4%) post-appendectomy). En-bloc and R0 resection rates were 86.6% and 80.4%, with no significant difference associated with different grades of appendiceal invasion (p=0.9 and p=0.4, respectively) or history of previous appendectomy (p=0.3 for both). Curative resection rate was 78.6%. Additional surgery was performed in 16 (14.3%) cases, with 10/16 (62.5%) corresponding to Toyonaga type 3 lesions (p=0.04). This included the treatment of 5 (4.5%) cases of delayed perforation and 1 acute appendicitis. A second case of acute appendicitis and 1 of delayed hemorrhage also observed, both treated conservatively.

Conclusion

To our knowledge, this is the largest reported series of ESDs for the treatment of appendicular lesions. Our results show that ESD is safe and effective in this context, and should thus be considered as a valuable treatment option. New traction strategies and devices should make it progressively less technically challenging and more widely accessible.

Introduction

Piecemeal endoscopic mucosal resection (EMR) vs endoscopic submucosal dissection (ESD) has been a long standing debate in the endoscopic community worldwide with multiple studies done to evaluate the preferred method to manage large colorectal neoplasms. Piecemeal EMR with thermal ablation of the margin has been strongly advocated and reported by certain groups to be a simple, inexpensive and effective technique and this has been preferred widely due to its perceived ease of performance and shorter learning curve.¹ However, close, repeated surveillance colonoscopy is recommended even when the lesion is thought to have been completely resected² as residual tumors can cause interval cancers.³ Some groups, mainly from east Asian countries, have recommended en bloc resection by ESD due to significantly lower risk of local recurrence and precise pathological diagnosis.⁴ But its usage is limited due to concerns about risk of serious adverse events. With improvement in training and devices, colorectal ESD is now being performed by various centers globally. This study aims to report the outcomes of an international, multicenter study on colorectal ESD.

Aims & Methods

Patients who underwent colorectal ESD for lesions greater than 20mm between January 2022 to April 2024 from centers in USA, Japan, and India respectively were included in this study. Recurrent lesions after endoscopic therapy, neoplasms identified in patients with ulcerative colitis, and non-epithelial lesions were included. Primary outcomes were en bloc and R0 resection rate, delayed adverse events (bleeding/perforation), and local recurrence rate. Secondary outcomes were procedure time, lesion size, and pathology. Univariate and multivariate analysis were done to identify the risk factors for primary outcomes.

Results

309 patients (median size, 40(27.5-60)mm; location rectum 52.4%, left colon 26.2%, right colon 21.4%) were involved in this study. The en bloc resection rate was 96.1% and R0 resection rate was 90.3%. 3 patients experienced delayed bleeding which was managed endoscopically. 2 patients underwent surgery for delayed perforation. 6 patients had a local recurrence. 67(23%) patients had intramucosal carcinoma on pathology. Univariate analysis showed lesser procedure time (median(IQR) 145(80-236.25) vs 270(180-300) minutes, P= 0.005) and smaller lesion size (median(IQR) 40(26-56.25) vs 60(40-90) mm, P= 0.004) were significant factors for successful en bloc resection. However, lesser procedure time (median(IQR) 74(29.5-97.5) vs 150(82.5-240) minutes, P= 0.034) led to an increased delayed adverse event rate. Multivariate analysis using Cox regression showed en bloc resection (odds ratio 0.038; 95% confidence interval 0.003-0.421; P= 0.008) was an independent factor preventing local recurrence.

Conclusion

This international, multicenter study with data from three countries shows favorable outcomes for colorectal ESD for large lesions. The high en bloc and R0 resection rate, and low adverse event rate show increased global adaptation to this procedure. Reduced local recurrence is an added benefit. Data from a more centers globally will be valuable to establish ESD as the standard for large colorectal neoplasms.

References

1. Sidhu M, Shahidi N, Gupta S et al. Outcomes of thermal ablation of the mucosal defect margin after endoscopic mucosal resection: a prospective, international, multicenter trial of 1000 large nonpedunculated colorectal polyps. Gastroenterology. 2021 Jul 1;161(1):163-70.
2. Gupta S, Lieberman D, Anderson JC et al. Recommendations for Follow-Up After Colonoscopy and Polypectomy: A Consensus Update by the US Multi-Society Task Force on Colorectal Cancer. Gastrointest Endosc 2020;91:463-485.e5.
3. Rutter MD, Beintaris I, Valori R et al. World Endoscopy Organization Consensus Statements on Post-Colonoscopy and Post-Imaging Colorectal Cancer. Gastroenterology 2018;155:909-925.e3.
4. Ohata K, Kobayashi N, Sakai E et al. Long-term outcomes after endoscopic submucosal dissection for large colorectal epithelial neoplasms: a prospective, multicenter, cohort trial from Japan. Gastroenterology. 2022 Nov 1;163(5):1423-34.