Introduction

The Endoscopic Pressure Study Integrated System (EPSIS) is a novel diagnostic device that enables continuous measurement of intragastric pressure during an upper endoscopy. The intragastric pressure (IGP) waveform is recorded during continuous insufflation of the stomach. Previous studies have shown that lower esophageal sphincter (LES) function can be evaluated by characterizing the IGP waveform, and this technique has been applied in diagnosing gastroesophageal reflux disease (GERD). We hypothesized that EPSIS could be useful for the dynamic evaluation of achalasia in conjunction with other diagnostic tests.

Aims & Methods

This single-center retrospective cohort study included patients who underwent EPSIS as an adjunct diagnostic tool for suspected esophageal motility disorders at a tertiary referral hospital between January 2022 and December 2022. The study group included patients with esophageal achalasia, and the control group consisted of cases with no abnormalities on upper endoscopy, absence of primary esophageal motility disorders with high-resolution manometry, barium swallow, and pathological reflux of acid exposure time ≤ 6% ruled out by 24-hour pH monitoring tests. Esophageal achalasia was confirmed using upper endoscopy, high-resolution manometry, and barium esophagram. The gradient of the pressure waveform obtained by EPSIS was compared between the two groups.

Results

During the study period, 35 cases in the esophageal achalasia group and 34 cases in the control group were included. The gradient of the pressure waveform (median) was significantly higher among achalasia patients (0.45 ± 0.17 vs. 0.31 ± 0.17 mmHg/sec, p=0.0008), indicating a failure of LES relaxation. A receiver operating characteristic (ROC) analysis was conducted, and the diagnostic performance of EPSIS for achalasia was determined to have an area under the curve (AUC) value of 0.76.

Conclusion

EPSIS in the achalasia group showed steep waveforms compared to the control group. ROC analysis also revealed that EPSIS had high diagnostic performance in detecting achalasia. These results suggest that EPSIS is a useful adjunct diagnostic tool for the diagnosis of esophageal achalasia. Functional endoscopy using EPSIS was found to be useful not only in diagnosing GERD but also in other disorders of LES function.

References

1. Inoue H, Shimamura Y, Rodriguez de Santiago E et al. Diagnostic performance of the endoscopic pressure study integrated system (EPSIS): a novel diagnostic tool for gastroesophageal reflux disease. Endoscopy. 2019 Aug;51(8):759-762.
2. Iwaya Y, Inoue H, Rodríguez de Santiago E et al. Endoscopic pressure study integrated system reflects gastroesophageal junction competence in patients with erosive esophagitis and Barrett´s esophagus. Dig Endosc. 2020 Nov;32(7):1050-1056.
3. Shimamura Y, Inoue H, Rodriguez de Santiago E et al. Characterization of intragastric pressure waveform in endoscopic pressure study integrated system: Novel diagnostic device for gastroesophageal reflux disease. Dig Endosc. 2021 Jul;33(5):780-787.
4. Fujiyoshi Y, Inoue H, Shimamura Y, Association between endoscopic pressure study integrated system (EPSIS) and high-resolution manometry. Endosc Int Open. 2022 Jun 10;10(6):E762-E768.

Disclosure

H Inoue declares: Olympus (advisory, educational activities), Top Corporation (advisory), Takeda Pharmaceutical Company (educational activities)

Introduction

The Endoscopic Pressure Study Integrated System (EPSIS) is a novel diagnostic device that continuously measures intragastric pressure during upper endoscopy. The waveform of intragastric pressure (IGP) is recorded during continuous insufflation of the stomach. Previous studies have shown that the lower esophageal sphincter (LES) function can be evaluated by characterizing the IGP waveform, and this technique has been applied in the diagnosis of gastroesophageal reflux disease(GERD). The gradient of the waveform decreases in cases of GERD, indicating LES dysfunction with an inability to hold up the insufflation. Anti-reflux mucosal ablation (ARMA) and anti-reflux mucosectomy (ARMS) are forms of endoscopic anti-reflux therapy through cardioplasty where in an ulcer at the level of the gastric cardia is created by resecting or ablating the mucosa to achieve gastric cardia stricture through the scarring process. In this study, we aimed to determine if EPSIS can be used to assess the therapeutic effect of endoscopic cardioplasty, such as ARMA or ARMS.

Aims & Methods

This was a single-center retrospective cohort study that included patients who underwent endoscopic cardioplasty, and EPSIS was performed before and after the endoscopic treatment between May 2018 and April 2023. 24-hour pH monitoring was performed post procedure to evaluated the treatment outcome. EPSIS was performed by using the pressure measuring system to monitor IGP. We characterized the pressure waveform shape by assessing the gradient of the waveform (mmHg/s), calculated by dividing the pressure difference by the insufflating time. The gradient of the waveform was compared before and after the procedure to confirm the change in the IGP waveform.

Results

EPSIS was performed before and after endoscopic cardioplasty (ARMS/ARMA) in 26 patients (mean age: 54.3 years, 19 males) during the study period. Twenty-two patients (84.6%) were evaluated by 24-hour pH monitoring at 2-6 months post-ARMA. The median AET significantly decreased from 20.4% to 5.4% (p=0.01). The pressure gradient of the IGP waveform significantly increased (0.15 vs. 0.25 mmHg/sec, p=0.001), indicating that the LES function was built up by the endoscopic intervention.

Conclusion

Functional endoscopy using EPSIS was found to be effective in evaluating the efficacy of endoscopic cardioplasty and has the potential to be applied not only in the diagnosis but also in the treatment of GERD.

References

1. Inoue H, Shimamura Y, Rodriguez de Santiago E et al. Diagnostic performance of the endoscopic pressure study integrated system(EPSIS): a novel diagnostic tool for gastroesophageal reflux disease. Endoscopy. 2019 Aug;51(8):759-762.
2. Iwaya Y, Inoue H, Shimamura Y, Rodriguez de Santiago E et al. Endoscopic pressure study integrated system reflects gastroesophageal junction competence in patients with erosive esophagitis and Barrett's esophagus. Dig Endosc. 2020 Nov;32(7):1050-1056.
3. Shimamura Y, Inoue H, Rodriguez de Santiago E et al. Characterization of intragastric pressure waveform in endoscopic pressure study integrated system: Novel diagnostic device for gastroesophageal reflux disease. Dig Endosc. 2021 Jul;33(5):780-787.
4. Fujiyoshi Y, Inoue H, Shimamura Y, Association between endoscopic pressure study integrated system (EPSIS) and high-resolution manometry. Endosc Int Open. 2022 Jun 10;10(6):E762-E768.

Disclosure

H Inoue declares; Olympus(advisory, educational activities), Top Corporation(advisory), Takeda Pharmaceutical Company(educational activities)

Introduction

Endoscopic submucosal dissection (ESD) for early upper gastrointestinal (GI) tumors creates large mucosal defects with risks of bleeding, perforation, and strictures, particularly in the esophagus where post-ESD stricture rates reach clinically significant levels. Current closure methods are inadequate for managing esophageal defects due to anatomical complexity. We present an endoscopy-integrated platform for real-time in situ nanofiber deposition during upper GI ESD, leveraging blow spinning technology to address these limitations.

Aims & Methods

This study aimed to
(1) engineer a coaxial nozzle system compatible with standard upper GI endoscopes (working channel ≤3.7 mm),
(2) optimize nanofiber deposition parameters for esophageal wound repair, and
(3) validate therapeutic efficacy in preclinical models.
A simplified in vitro setup was used to optimize polymer composition (polycaprolactone/gelatin blends), gas pressure (0.2-0.5 MPa), and blowing distance (10-20 cm). A murine skin wound model was employed to validate nanofiber adhesion and repair properties. For endoscopic integration, a dual-layer coaxial nozzle was designed using computational fluid dynamics (CFD), featuring an inner polymer delivery channel (0.5 mm inner diameter) and an outer airflow channel (1.2 mm inner diameter) to generate nanofibers via controlled airflow. The nozzle was fabricated using stereolithography 3D printing with biocompatible resins and integrated into a compact endoscopic system. Functional testing was performed in a transparent esophageal phantom under simulated physiological flushing, followed by in vivo validation in a porcine esophageal ESD model comparing nanofiber-treated wounds to controls.

Results

The 3D-printed coaxial nozzle (3.0-mm outer diameter) demonstrated full compatibility with standard upper GI endoscopes. In simulated esophageal conditions, the platform achieved uniform nanofiber deposition (fiber diameter: 15.2±3.6 μm) with robust adhesion unaffected by luminal flushing. In the porcine esophageal ESD model, immediate nanofiber application provided complete wound coverage, reduced perioperative bleeding, and prevented stricture formation. Histological analysis at 4 weeks revealed markedly reduced fibrosis and enhanced mucosal regeneration in treated groups compared to controls. The system operated seamlessly within the standard ESD workflow without procedural interference.

Conclusion

This study develops the first endoscopy-compatible platform for real-time in situ nanofiber deposition, demonstrating preclinical efficacy in addressing post-ESD complications in the upper gastrointestinal tract. By synergizing mechanical barrier formation with bioactive healing modulation, the technology reduces stricture risks and promotes mucosal repair in porcine esophageal ESD models. While current findings underscore its translational promise, further optimization of biomaterial formulations and rigorous human trials are essential steps toward clinical adoption in therapeutic upper GI endoscopy.

Introduction

Medical treatment with acid suppressive medications is effective in managing gastroesophageal reflux disease (GERD) symptoms, but some experience persistent symptoms. To address this, we have developed minimally invasive endoscopic intervention: anti-reflux mucosectomy (ARMS) and anti-reflux mucosal ablation (ARMA). In ARMS and ARMA, we artificially create an ulcer at the level of the gastric cardia by resecting or ablating the mucosa and achieve cardioplasty through the scarring process. Previous studies have shown favorable outcomes. However, some challenges of ARMS and ARMA remains including the slow onset of therapeutic effect and the risk of delayed bleeding in patients who are taking antithrombotic medications. Thus, we developed ARM-P (anti-reflux mucoplasty), in which the mucosal defect is closed immediately after resection with the expectation of faster treatment efficacy and reduced risk of postoperative bleeding. The closure of the mucosal defect was achieved with traction using endoclips and support threads.

Aims & Methods

A retrospective case series was conducted at the single tertiary referral center from October 2022 to March 2023. We included all consecutive patients who underwent ARM-P. Inclusion criteria were the presence of at least one typical reflux symptom more than two times a week despite double-dose PPI treatment for at least 6 months, or pathologic esophageal acid exposure defined by acid exposure time > 6.0%. Frequency Scale for the Symptoms of GERD (FSSG) and Gerd Q questionnaire at baseline and at 2 months post-ARM-P were evaluated.

Results

Ten patients (6 males, median age 56.5 years, range 33-76 years) who underwent ARM-P during the study period; one patient had a history of Toupet fundoplication, but no other previous surgery. The median procedure time was 95 minutes (range: 45-205), and all patients had no adverse events such as bleeding or perforation. The median hospital stay was 5 days (range: 5-9 days). Of the 9 patients followed up 2 months after ARM-P, all showed improvement in Hill's flap grade from a median of 2 (range: 1-3) to 1 (range: 1-1). 6 patients were able to discontinue acid suppression drugs, and their symptom scores improved significantly: FSSG from 186 to 121 (p=0.05) and GERDQ from 56 to 46 (p=0.01).

Conclusion

Technical and clinical results, including improvements in cardia morphology and patient symptoms, were evaluated. The results confirmed that it is technically feasible, that the cardia morphology was modified, and that the patient's symptoms improved.

References

-Inoue H, Ito H, Ikeda H, et al. Anti-reflux mucosectomy for gastroesophageal reflux disease in the absence of hiatus hernia: a pilot study. Ann Gastroenterol. 2014; 27: 346-51.
-Sumi K, Inoue H, Kobayashi Y, et al. Endoscopic treatment of proton pump inhibitor-refractory gastroesophageal reflux disease with anti-reflux mucosectomy: Experience of 109 cases. Dig Endosc. 2021; 33: 347-54.
-Inoue H, Tanabe M, de Santiago ER, et al. Anti-reflux mucosal ablation (ARMA) as a new treatment for gastroesophageal reflux refractory to proton pump inhibitors: a pilot study. Endosc Int Open. 2020; 8: E133-E8.
-Rodriguez de Santiago E, Sanchez-Vegazo CT, Penas B, et al. Antireflux mucosectomy (ARMS) and antireflux mucosal ablation (ARMA) for gastroesophageal reflux disease: a systematic review and meta-analysis. Endosc Int Open. 2021; 9: E1740-E51.
-Inoue H, Takeshita K, Hori H, Muraoka Y, Yoneshima H, Endo M. Endoscopic mucosal resection with a cap-fitted panendoscope for esophagus, stomach, and colon mucosal lesions. Gastrointest Endosc. 1993; 39: 58-62.
-Inoue H, Shimamura Y, Fukuda M, Ando R, Kato H, Tanabe M, Julius Navarro M. Loop-10” line-assisted clip closure method: closure of perforation in re-do peroral endoscopic myotomy VideoGIE. 2023.

Disclosure

H Inoue declares: Olympus (advisory, educational activities), Top Corporation (advisory), Takeda Pharmaceutical Company (educational activities).

Introduction

Various minimally invasive endoscopic procedures have aimed at filling the gap between medical therapy and surgical intervention. Anti-reflux mucosal ablation (ARMA) is a novel endoscopic treatment in which mucosal ablation of the gastric cardiac mucosa with either a thermal probe or with an argon plasma catheter is performed to induce scar formation to enhance the gastroesophageal junction flap valve.

Aims & Methods

We aimed to assess the feasibility, effectiveness, and safety of ARMA. All patients who underwent ARMA between May 2018 and December 2022 were retrospectively analyzed using a prospectively collected database at two referral centers. We offered ARMA to patients if they met the following criteria:
1) Patients with chronic (> six months) GERD symptoms, including heartburn, regurgitation, and/or extraesophageal symptoms;
2) Objective GERD diagnosis based on the Lyon consensus, either on an acid exposure time in the distal esophagus > 6% (definitive GERD) or on the existence of hypersensitive esophagus;
3) No significant sliding hernia (< 3cm);
4) Symptoms refractory to Proton pump inhibitors (PPI) or potassium competitive acid blockers (PCAB) or PPI/PCAB-sensitive GERD patients unwilling to maintain long-term acid suppression drugs.
GERD questionnaires, upper endoscopy, and 24-hour pH monitoring were documented at 2-6 months and 12 months after ARMA. Clinical success was defined as a > 50% reduction in validated GERD questionnaires.

Results

A total of 80 ARMA procedures in 68 patients were analyzed. Definitive GERD was diagnosed in 44 (64.7%) patients and 24 (35.3%) with reflux hypersensitivity. The ARMA procedure had technical success in all cases, and mucosal ablation of the planned area was completed. The median procedural time was 32 (range 16-100) minutes. Clinical success at 2-6 months and one year of a first ARMA procedure was 60% (39/65, 95% CI 48%-71%) and 70% (21/30, 95% CI 52%-83%), respectively. The median GERD-HRQL score at 2-6 months improved significantly from 26 (range, 5 – 51) to 11 (range, 0-50) (p < 0.001). Fifty-one patients (71.8%) were evaluated by 24-hour pH monitoring at 2-6 months post-ARMA. The median AET significantly decreased from 5.3% to 0.7% (p=0.003). In addition, the rate of esophagitis decreased (p< 0.001). Eight patients underwent a second ARMA, and the second ARMA had a clinical success rate of 50% (4/8). All cases had no immediate adverse events, but ten (12.1%) patients with transient stenosis required balloon dilatation. Six patients (7.5%) experienced delayed bleeding after a median of 10 days (range 1-21), which was controlled with conservative treatment (n = 1) or repeated endoscopy (n = 5). No patient required a blood transfusion. Multivariate analysis performed to identify predictors of the short-term success of a first ARMA did not find any factor associated with the primary outcome.

Conclusion

Our data shows that ARMA in patients without significant sliding hernia is technically feasible, reproducible, safe, and improves GERD symptoms in approximately two out of three patients in the short term. Patients with reflux hypersensitivity and proven GERD may be the appropriate candidates regardless of their response to PPI/PCAB.

References

1. Rodríguez de Santiago E, Sanchez-Vegazo CT, Peñas B, et al. Anti-reflux mucosectomy (ARMS) and anti-reflux mucosal ablation (ARMA) for gastroesophageal reflux disease: a systematic review and meta-analysis. Endosc Int Open 2021;9:E1740-e1751.
2. Inoue H, Tanabe M, de Santiago ER, et al. Anti-reflux mucosal ablation (ARMA) as a new treatment for gastroesophageal reflux refractory to proton pump inhibitors: a pilot study. Endosc Int Open 2020;8:E133-e138.
3. Gyawali CP, Kahrilas PJ, Savarino E, et al. Modern diagnosis of GERD: the Lyon Consensus. Gut 2018;67:1351-1362.

Disclosure

Enrique Rodríguez de Santiago declares Olympus (speaker fee, advisory, proctorship, and educational activities), Norgine (educational activities), and Casen (educational activities). Carlos Teruel declares Norgine (educational activities). Haruhiro Inoue declares Olympus (advisory, educational activities), Top Corporation (advisory), and Takeda Pharmaceutical Company (educational activities)

Introduction

Endoscopic depth diagnosis is essential for the treatment decision of Barrett's esophageal adenocarcinoma (BEA). However, it is sometimes difficult to diagnose due to the anatomy of the esophagogastric junction, such as the difficulty of luminal distension. For inconclusive cT1a or cT1b lesions, we introduced staging ESD, allowing for histologic diagnosis for depth invasion. However, the clinical feasibility and significance of staging ESD remain unclear.

Aims & Methods

In this study, we evaluated the performance of endoscopic depth diagnosis of cT1 BEA and the appropriate treatment strategy.
This study included cT1N0M0 BEA treated with ESD or surgery from January 2015 to June 2024. The cases with poorly differentiated component on target biopsy were excluded. Endoscopic depth diagnosis was based on macroscopic appearance (such as the following findings suggestive of cT1b: polypoid, mixed macroscopic type, thickness, hardness, severe redness, and ulceration). EUS was added at the discretion of the endoscopist. We made the treatment decision based on our multidisciplinary conference, and the final diagnosis was classified as conclusive cT1a or cT1b, and inconclusive cT1a or cT1b. We performed ESD for conclusive cT1a, and surgery for conclusive cT1b. And we performed staging ESD for inconclusive cT1a or cT1b. Curative resection was defined as pT1a with R0 resection, and without lymphovascular invasion or poorly differentiated component.

Results

This study included 54 lesions in 52 patients. The median age was 66 years (43-92). There were 42 male patients. Siewert type [type I/type II] were 12 and 42, respectively. Background Barrett’s esophagus [SSBE/LSBE] were 36 and 16, respectively. The median size was 20mm (5-50). Major macroscopic appearances [0-I/0-IIa/0-IIb/0-IIc] were 11, 19, 1, and 23, respectively. Histology on targeted biopsy [tub1/tub2] were 41, 13, respectively. 39 lesions were diagnosed by white light endoscopy alone, and 15 lesions were comprehensively diagnosed by additional EUS. 41 lesions were diagnosed as cT1a and 13 lesions were diagnosed as cT1b. ESD and surgery were performed for 47 and 7 lesions, respectively. Pathologic depths [T1a/T1b/T2] were 42, 11, and 1, respectively. The sensitivity, specificity, and positive predictive value of endoscopic diagnosis of T1b were 25.0%, 76.2%, and 23.1%, respectively. 10 of 54 (18.5%) T1a lesions were overdiagnosed. Staging ESD was performed for 20 lesions, and all of them achieved en bloc resection without adverse events. R0 resection was achieved in 13 of 14 (92.9%) cT1a and 5 of 6 (83.3%) cT1b, respectively. Curative resection was achieved in 8 of 14 (57.1%) cT1a and 4 of 6 (60.0%) cT1b, respectively. 3 of 54 (5.6%) T1a were diagnosed as conclusive cT1b, and underwent surgery, leading to overtreatment.

Conclusion

The diagnostic performance of endoscopic depth diagnosis is insufficient, leading to overdiagnosis. Staging ESD for inconclusive cT1 BEA is technically feasible and can be an option to avoid overtreatment.