Introduction

A self-assembling peptide solution (PuraStat) is a new hemostatic agent for gastrointestinal bleeding just by smearing through an endoscope. Recently PuraStat has been reported to be useful for hemostasis of gastrointestinal bleeding. In colonic diverticular hemorrhage, endoscopic clipping was often used, because of its simplicity and safety. Although PuraStat is expected to useful for hemorrhage, there is no study of its usefulness of hemostasis and hemostatic effects such as rebleeding were unknown.

Aims & Methods

The objective was to investigate the usefulness of PuraStat in diverticular hemorrhage. This study was a retrospective case-control study conducted by at Kochi Red Cross Hospital in between April 2021 and January 2023 under ethical approval. The study included with 57 patients with colonic diverticular hemorrhage who were treated with only endoscopic clipping (Group A: 43 patients) or endoscopic clipping with PuraStat (Group B: 14 patients). The success rate for endoscopic hemostasis, the rate of rebleeding, the rate of transition to arterial embolization and time to rebleeding were evaluated in each group, and differences between two groups were also examined by Fisher's exact test or Student’s t-test.

Results

Total procedure times both Group A and Group B were 16.3 min and 27.5 min. This study in Group A and Group B showed 90.1% and 100% for success rate (p=0.563), 32.5% and 42.9% for the rate of rebleeding (p=0.530), 7.0% and 12.5% for the rate of transition to arterial embolization (p=0.587), 26 h and 33 h for time to rebleeding (p=0.438) respectively. Treatment result is not improved by a combination of clipping and Purastat.

Conclusion

The combination treatment endoscopic clipping of PuraStat has no additional effects in colonic diverticular hemorrhage than endoscopic clipping alone.

Introduction

Delayed bleeding remains a significant complication after endoscopic resection procedures in the gastrointestinal tract. Effective strategies to prevent post-procedural bleeding and promote optimal healing are critical for improving patient’s outcomes. Self-assembling peptide (SAP) is a new hemostatic agent that forms protective nanofibers scaffold after contact with body fluids. Its application may reduce delayed bleeding and support tissue healing after endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD). Early clinical data has shown promising results, but evidence is still limited.

Aims & Methods

This study evaluates the impact of SAP use on delayed bleeding rates and healing process after advanced endoscopic therapies. The findings may support the integration of SAP into standard post-endoscopic care protocols.
A retrospective analysis was conducted on patients after EMR or ESD at a single tertiary endoscopy center. Two primary outcomes were assessed: delayed bleeding and post-resection defect healing. Delayed bleeding was defined as clinically evident bleeding occurring within 30 days following the index endoscopy. Healing was evaluated endoscopically using the Sakita-Fukutomi classification at 4, 8, and 24 weeks. The size of the resection defect was measured during the procedure using endoscopic forceps or a polypectomy snare for reference. Data were collected from medical reports.​​​​​​​​

Results

A total of 141 patients (55 women, 86 men) were included in the analysis. The majority underwent ESD (n=96; 68 %), followed by piece-meal EMR (n=36; 26 %), hybrid procedure EMR+ESD (n=7; 5 %), and en-bloc EMR (n=2; 1 %). 35 lesions (25 %) were located in upper GI tract, 106 lesions (75 %) in colon and rectum with an average lesion size of 48 mm. R0 resection was achieved in 71 (78 %) of all 91 en-bloc resections. Delayed bleeding occurred in 6 patients (4.3%), with an average onset of 4 days after the procedure. All these patients had subsequent endoscopy with various hemostatic approaches, including SAP alone (n=3), SAP with coagulation (n=1), coagulation with hemoclips (n=1), and coagulation with hemospray (n=1). In all cases hemostasis was achieved. 2 patients required transfusion. The post-resection defect averaged 51 mm after index endoscopy. At 4, 8, and 24 weeks post-procedure, its size decreased to 20 mm, 14.5 mm, and 10 mm, marking reductions of 61%, 72%, and 80%, respectively.

Conclusion

SAP is effective in preventing delayed bleeding and healing post-resection defects. Its use can increase overall safety of advanced endoscopic procedures. Further studies are needed to establish optimal indications and integration into standard post-procedure protocol.
Supported by program projects of the Ministry of Health of the Czech Republic with reg. no. NU22-08-00424, MO1012 and Cooperatio.

Introduction

Delayed bleeding is a frequently observed complication after endoscopic mucosal resection of large adenomas of colorectum and duodenum. Even though the associated mortality is low, delayed bleeding causes significant morbidity and use of health care resources. Clip closure of the resection field reduces delayed bleeding, but it is time consuming and often complete closure is not achieved. Hemostatic gels and powders can be applied quickly and easily. These agents are in use for the treatment of active bleeding, but it is unknown, whether they will also prevent delayed bleeding when applied to the resection field prophylactically.

Aims & Methods

We conducted a randomized controlled trial of patients undergoing hot-snare endoscopic mucosal resection of flat lesion in the duodenum and colorectum at 15 centers in Germany. Lesions had to be non-pedunculated and measure at least 10 mm in the duodenum and 20 mm in the colorectum. Immediately after resection was completed patients were randomized to hemostatic gel application (intervention group) or no prophylaxis (control group). The primary endpoint was clinically significant delayed bleeding rate (CSDB) within 30 days after resection. Secondary endpoints included transfusion requirements, other complications, wound healing and lesion recurrence.

Results

A total of 233 patients were included in the trial. We performed a planned interim analysis when 200 patients were available for evaluation of the primary end point; at this point we stopped enrollment in the trial due to futility. Of the 200 patients included in the interim analysis, 100 (88 colorectal, 12 duodenal) were included in the intervention group and 100 (88 colorectal, 12 duodenal) in the control group. Groups were comparable in terms of patient age, sex, comorbidities, and lesion localization. CSDB occurred in 13 cases (13%) in the intervention group and in 6 cases (6%) in the control group. This difference was not statistically significant (p=0.146 Fisher’s Exact Test). CSDB rates for colorectal lesions were 10% vs. 4.5% (intervention vs. control group) and for duodenal lesions 33% vs. 17%. Follow-up for patients already enrolled is continuing and data lock for the full study cohort is expected in May 2024. The full data set will be presented at UEG Week.

Conclusion

The application of a hemostatic gel following endoscopic mucosal resection of large non-pedunculated lesions in the duodenum and colorectum does not reduce the rate of CSDB.

Disclosure

OM and TVH have received lecture fees from Puramatrix (the company producing Purastat gel). TW has received lecture fees from Fuji (the company marketing Purastat in Germany).

Introduction

Accurate assessment of colorectal polyp size is essential for determining appropriate surveillance intervals and therapeutic approaches. However, visual estimation remains inherently imprecise, especially among less experienced endoscopists. While virtual scale endoscopy (VSE)1 offers an in-procedure solution for real-time mea.

Aims & Methods

This study aimed to evaluate the long-term educational benefits of self-directed training using short instructional videos based on VSE. Thirty-three endoscopists (15 experts and 18 non-experts) participated in a structured learning program using four sets of videos (SET1–SET4), each containing 20 colorectal lesions recorded during colonoscopy. Following initial exposure and evaluation with SET1 and SET2, participants underwent two follow-up tests (SET3 and SET4) 8–12 weeks later without interim re-training, to assess retention of estimation accuracy. The primary outcome was the total absolute error between estimated and actual lesion diameters, summed across 20 lesions per set. Secondary analysis evaluated differences between expert and non-expert groups.

Results

After initial training, participants showed improved size estimation accuracy (SET1: 34.7 ± 6.6 mm vs. SET2: 30.7 ± 7.7 mm, p = 0.048). Importantly, this effect was sustained after 8–12 weeks, with mean total error in SET3 (28.6 ± 6.9 mm) remaining significantly lower than the pre-training baseline (SET1, p = 0.006). Similarly, SET4 showed continued improvement over baseline (31.7 ± 7.1 mm, p = 0.025), despite no further exposure to training content. Non-experts demonstrated a more pronounced benefit, suggesting that the self-learning video format may be particularly effective for early-career endoscopists. No adverse effects or dropouts occurred during the study.

Conclusion

This is the first study to demonstrate that a brief, self-directed video-based training program using virtual scale endoscopy can achieve not only immediate improvements in polyp size estimation accuracy, but also sustain those gains over time. Given its simplicity, scalability, and minimal resource requirement, this educational approach may serve as a valuable adjunct in structured endoscopy training programs, especially for novice endoscopists or in settings with limited access to formal instruction.

References

1. Yoshioka M, Sakaguchi Y, Utsunomiya D, et al. Virtual scale function of gastrointestinal endoscopy for accurate polyp size estimation in realtime: a preliminary study. J Biomed Opt 2021;26:096002.

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

Endoscopic hemostasis using clips is widely used as a safe and effective first-line treatment for colonic diverticular bleeding, but rebleeding after hemostasis remains a common issue. In recent years, the Over-the-Scope Clip (OTSC) has gained attention as a new endoscopic treatment device due to its stronger tissue grasping ability and potentially higher hemostatic effectiveness compared to conventional clips. However, clinical cases remain limited, and more evidence is needed. This study evaluates the outcomes of colonic diverticular bleeding treated with OTSC.

Aims & Methods

The purpose of this study was to compare conventional clip hemostasis and additional treatment with OTSC for colonic diverticular bleeding. The subjects were patients at our institution from April 2014 to April 2024 in whom the bleeding source was endoscopically identified and treated. Patients treated with clips alone were classified into the clip group, while those who underwent additional OTSC treatment at the same site after clip treatment to prevent rebleeding were classified into the OTSC group. The clip and OTSC groups included 65 and 11 patients, respectively. There were no significant differences between the groups in terms of sex (female/male: 12/53 vs. 4/7), age (median: 64 [35-96] vs. 70 [53-84]), or anticoagulant use (14/65 vs. 3/11). Rebleeding was defined as the appearance of visible bloody stool after endoscopic treatment, and it was the primary endpoint.

Results

Rebleeding occurred in 33 of 65 cases in the clip group and 0 of 11 cases in the OTSC group, showing a significant difference in rebleeding rate (0% [0/11] vs. 50.0% [33/66]; P < 0.05). Multivariate analysis identified OTSC as an independent preventive factor for rebleeding (p = 0.001). No complications such as bowel perforation, diverticulitis (localized infection), or intestinal stenosis were observed in either group. Furthermore, when comparing costs, including readmissions due to rebleeding, the average cost in the clip group (15 out of 66 cases readmitted) was €5897 ± 3907, with a median of €4302. In the OTSC group (0 readmissions), the average cost was €4580 ± 2143, with a median of €4284, indicating that OTSC treatment was not inferior in cost-effectiveness compared to clip treatment (p = 0.124).

Conclusion

Treatment using OTSC significantly reduced rebleeding compared to conventional clip treatment, demonstrating high safety and comparable cost-effectiveness, suggesting it is an effective treatment method.

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.