Introduction

Submucosal injection solutions create a mucosal cushion, which provides sufficient separation between the muscle layers and resection sites. It decreases the risk of perforation, without interfering with histological evaluation. In Japan, several submucosal injection solutions, including normal saline, hyaluronate solution, and sodium alginate, have been used during endoscopic resection procedures. A novel fully synthetic and self-assembling peptide solution, PuraLift (3-DMatrix, Tokyo, Japan), is a non-biologic preparation that self-assembles to form a gel composed of nanofibers upon contact with a neutral pH or the response to inorganic salts such Na⁺ and K⁺.

Aims & Methods

In the present study, we aimed to evaluate the efficacy and safety of PuraLift in endoscopic mucosal resections (EMRs) of colorectal neoplasms. This study included 70 patients with 110 neoplastic lesions, measuring 5–20 mm in the colorectal mucosa, from five referral hospitals in Japan, between January and May 2023, who underwent EMR with PuraLift. This study was conducted by board-certified fellows of the Japan Gastroenterological Endoscopy Society (48.2%) and the others. The primary outcome measures were included complete resection rate (en-bloc resection with a histopathologically negative resection margin) and maintenance of mucosal lesion lifting during endoscopic resection (calculated as the number of additional injections required due to the loss of mucosal lesion lifting). The secondary outcome was safety, evaluated by analyzing adverse events during the study period.

Results

The median age and sex ratio (male/female) of the patients were 67 (38–86) years and 43/27, respectively, and 14 patients (20%) were treated with antithrombotic agents. Among the lesions, 29 (26.4 %) were laterally spreading tumors, and the remaining were protruding lesions. The mean tumor size was 9.45 ± 3.26 mm (range: 5–20 mm).
Only two patients required an additional injection due to the loss of mucosal lesion lifting, and the mean injection volume was 2.01 (±2.46) mL. En-bloc resection was performed for 109 lesions (99.1%). Eight lesions (7.3%) showed inconclusive horizontal margins on histopathological evaluation. No cases of bleeding, perforation, or other accidental intraoperative event was observed. Evaluation of the ease of EMR (injection and snaring) with PuraLift revealed easy or normal results for 99.1% (109/110) of the lesions.

Conclusion

This novel submucosal injection material enabled sufficient lifting of the colorectal intramucosal lesion during EMR, reducing the need for additional injections and total amount of local injections. Furthermore, this solution contains the same ingredients as the hemostatic material PuraStat (3-DMatrix); therefore, it may have a perioperative hemostatic effect and promote wound healing, contributing to the reduction of complications.

Introduction

The incidence of colorectal neuroendocrine tumors (NETs) has increased over the past decades with early detection during screening colonoscopy.^1,2 The C-NET STUDY is a Japanese multicenter prospective cohort study, in which patients with colorectal NETs were consecutively enrolled.³

Aims & Methods

The study aimed to evaluate the short-term outcomes of various methods of endoscopic resection for colorectal NETs. Among the C-NET STUDY registrants, patients with colorectal NETs who underwent endoscopic treatment as the initial therapy were included. Patients who received treatment at a previous institution before participating in this study, biopsy diagnosed but the resected lesion was not pathologically diagnosed as NET, and who had defective data were excluded. The study protocol stated that endoscopic treatment should be performed if the tumor size is <10 mm in depth from the mucosa to the submucosa, with no ulceration or depression on the surface. For lesions with no treatment consensus in various guidelines, treatment selection was determined by each physician according to their policy in clinical practice. With respect to endoscopic resection procedures, several techniques were available in clinical practice, including endoscopic mucosal resection with a ligation device (ESMR-L), endoscopic mucosal resection using a cap (EMR-C), and endoscopic submucosal dissection (ESD). The major outcome measurements were short-term treatment outcomes, including en bloc resection rate, complete resection (defined as en bloc resection with tumor-free margin (R0)) rate, need for hospitalization, and treatment-related complications based on treatment modalities. Clinicopathological risk factors of incomplete resection (R1/RX) was also examined.

Results

A total of 472 patients with 477 colorectal NETs received endoscopic treatment. Of these, 418 patients with 421 lesions, who met the eligibility criteria, were included in the analysis. The median patient age was 55 years, and 56.9% of the patients were male. The lower rectum was the most common site (88.6%), and lesions <10 mm accounted for 87% of the cases. Among all cases, en bloc resection and R0 resection were achieved in 421 (100%) and 398 (94.5%) lesions. A total of 267 (63.4%) patients required hospitalization for treatment, with a median hospital stay of 3 days. Endoscopic mucosal resection with a ligation device (ESMR-L, 56.5%) was the most common method, followed by endoscopic submucosal dissection (ESD, 31.4%) and endoscopic mucosal resection using a cap (EMR-C, 8.5%). R0 resection rates <10 mm were 95.5%, 94.8 %, and 94.3% for ESMR-L, ESD, and EMR-C, respectively. All the treatment-related complications observed in 16 (3.8%) patients were treated conservatively. There were no independent clinicopathological risk factors for R1/X resection.

Conclusion

ESMR-L, ESD, and EMR-C were equally effective and safe techniques for colorectal NETs with diameter <10 mm (UMIN000025215).

References

1. Kooyker AI, Verbeek WH, van den Berg JG, et al. Change in incidence, characteristics and management of colorectal neuroendocrine tumours in the Netherlands in the last decade. United European Gastroenterol J 2020;8:59-67.
2. Ito T, Igarashi H, Nakamura K, et al. Epidemiological trends of pancreatic and gastrointestinal neuroendocrine tumors in Japan: a nationwide survey analysis. J Gastroenterol 2015;50:58-64.
3. Sekiguchi M, Hotta K, Takeuchi Y, et al. Characteristics of colorectal neuroendocrine tumors in patients prospectively enrolled in a Japanese multicenter study: a first report from the C-NET STUDY. J Gastroenterol 2022; 57: 547-558.

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.

Introduction

According to the European Society of Gastrointestinal Endoscopy (ESGE) guidelines, the curative criteria of endoscopic resection (ER) for T1 colorectal cancer (CRC) are well/moderately differentiated adenocarcinoma or papillary carcinoma, no lympho-vascular invasion, submucosal invasion depth <1000μm, and budding grade (BD) 1. Although an additional surgery is recommended for non-curative ER, the incidence of lymph node metastasis (LNM) is less than 12%. Many reports on lymph node metastasis and recurrence in T1 CRC originate from academic centers, with limited reports of real-world data.

Aims & Methods

The aim of this study was to clarify clinical outcomes in patients with T1 CRC. A total of 686 consecutive patients (Male:447 Female:239) were enrolled from April 2009 to August 2019 at 10 institutions. Exclusion criteria included evidence of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, or inflammatory bowel disease; presence of active, malignant diseases in any other organs; presence of synchronous or metachronous advanced CRC. Risk factors of LNM and recurrence, and survival were analyzed.

Results

The mean age of patients was 69.3±10.2 years old. The mean tumor size was 20.3±12.4mm. The location of the lesion was 439(64%) and 247(36%) in the colon and rectum, respectively. The histopathological types included 681 cases of differentiated type and 5 cases of undifferentiated type. A number of patients with ER without additional SR (ER alone) were 176(curative resection 86, non-curative resection 90), those with SR (SR alone) were 510, and those with ER and additional SR (ER + additional SR) were 116.
(i) Risk factor of LNM: LNM was found in 13(11.2%) patients with ER + additional SR and in 40(10.6%) patients with SR alone. In multivariate analysis, positive lymphatic invasion and tumor size were significant independent risk factor for LNM (OR 5.9, 95% CI [2.2-16], p<0.01, OR 1.04, 95%CI［1.00-1.07］p=0.028, respectively).
(ii) Recurrence: During the mean observation period of 45.5±34.3 months, recurrence was found in 27(3.9%) patients. No recurrence was found in the ER curative resection group. Although 43% (90/206) patients with ER non-curative resection did not receive additional SR, there was no significant difference in recurrence rate between ER alone with non-curative resection and ER + additional SR groups (5.6% (5/90) vs. 2.6% (3/116), respectively; p=0.3). In the SR alone group, recurrence was found in 4.8% (19/394). The significant independent risk factor for recurrence was tumor size (OR 1.12, 95% CI [1.05-1.2], p<0.01).
(iii) Survival: There were 50 deaths (7.3%, 76.2±6.6 years old) during the observation period of 45.5±34.3 months, but CRC-related death was found in only 6 cases (0.8%); one case was ER alone with non-curative resection and the other cases were SR alone.

Conclusion

This study suggests that the possibility of expanding the indication for ER of T1 CRC, because positive lymphatic invasion and tumor size were the only risk factor for LNM and better long-term outcomes were shown despite including significant number of patients with ER alone with non-curative resection. Fifty cases of death showed a higher average age and fewer deaths from CRC. Therefore, even in cases of non-curative resection for T1 CRC after ER, avoiding additional SR may be considered due to advanced age or comorbidities.

Introduction

Endoscopic full-thickness resection (EFTR) with the full-thickness resection device (FTRD) has become the standard technique for selected non-lifting colorectal adenoma but tumor size is the major limitation. However, large lesions might be approached in combination with endoscopic mucosal resection (EMR). Herein, we report the largest single-center experience to date of combined EMR/EFTR (Hybrid-EFTR) in patients with large (≥ 25 mm) non-lifting colorectal adenoma not amenable to EMR or EFTR alone.

Aims & Methods

This is a single-center retrospective analysis of consecutive patients who underwent Hybrid-EFTR of large (≥ 25 mm) non-lifting colorectal adenoma. Outcomes of technical success (successful advancement of the FTRD with consecutive successful clip deployment and snare resection), macroscopic complete resection, adverse events and endoscopic follow-up were evaluated.

Results

75 patients with non-lifting colorectal adenoma were included. Mean lesion size was 36.5 mm (range 25-60 mm) and 66.6 % were located in the right-sided colon. Technical success was 100 % with macroscopic complete resection in 97.3 %. Mean procedure time was 83.6 minutes. Adverse events occurred in 6.7 % leading to surgical therapy in 1.3 %. Histology revealed T1 carcinoma in 16 %. Endoscopic follow-up was available in 93.3 % (mean follow-up time: 8.1 months, range 3-36 months) and showed no signs of residual or recurrent adenoma in 88.6 %. Recurrency (11.4 %) was treated endoscopically.

Conclusion

Hybrid-EFTR is safe and effective for advanced colorectal adenoma which cannot be approached by EMR or EFTR alone. Hybrid-EFTR expands the indication of EFTR substantially in selected patients.

Disclosure

BM received fees for research activities and lecture fees from Ovesco Endoscopy AG.
KC received fees for FTRD training courses and lecture fees from Ovesco Endoscopy AG.
IE, NS and AW have no disclosures to report.

Introduction

Colorectal endoscopic mucosal resection (EMR) is the treatment of choice for large colorectal lesions, but it has an important recurrence risk, requiring endoscopic surveillance. This study aims to identify factors associated with relapse and complications, by analysing the 5-year follow-up.

Aims & Methods

Prospective cohort study conducted in a single centre, including all patients submitted to colorectal pEMR between 2009 and 2021 with follow-up ≥3 months. We analysed lesion characteristics, calculated Sydney EMR recurrence tool (SERT) and SMSA (size, morphology, site, access) scores and compared complication and recurrence rates and respective risk factors.

Results

Included 568 mucosal resections, median age 69.5 years (IQR 62.3-76.0), male sex 58.1%. From the lesions included: 32.6% ≥40mm; 51.6% plane and 48.4% sessile; 35.9% in the right colon, 27.6% in the rectum, 23.2% in the transverse colon and 13.2% in the left colon. The median SMSA score was 4 (IQR 3-4) and median SERT score 1 (IQR 0-2), complication rate of 7.0% (bleeding, n=33; perforation, n=4; post-polypectomy syndrome, n=3) and overall recurrence rate of 20.3%: 15.1% in 3 months, 6.3% in 12 months, 2.5% in 36 months and 0% in 60 months.
The variables associated with recurrence were size ≥40mm (35.0% vs. 14.6%, p<0.001), anal location (35.1% vs. 19.7%, p<0.01), SERT score>0 (27.5% vs. 11.8%, p<0.001) and SMSA score=4 (30.6% vs. 11.5%, p<0.001), but not argon plasma therapy (22.8% vs. 18.7%, p=0.26). By logistic regression, size ≥40mm was associated with higher recurrence, but not statistically significant (OR 3.19, CI95% 0.69-1.63).
Use of anticoagulant/antiplatelet drugs was associated with higher risk of complications (12.7% vs. 4.7%, p<0.001), particularly bleeding (11.4% vs. 4.2%, p<0.01), with no difference for size ≥40mm (9.2% vs. 6.0%, p=0.17) or SMSA score=4 (7.6% vs. 6.5%, p=0.61).

Conclusion

The 5-year surveillance proved colorectal EMR’s efficacy. Recurrence is higher in lesions ≥40mm, with anal location, SERT score>0 and SMSA score=4, whereas bleeding is more frequent with the use of anticoagulant/antiplatelet drugs.