Efficacy and safety of same-day preparation with sodium picosulfate plus magnesium citrate on the day of colonoscopy for bowel preparation: Multicenter, single-arm, open-label study.

BACKGROUND AND AIM: Sodium picosulfate plus magnesium citrate (SP + MC) is a well-tolerated bowel preparation agent. However, Japan currently approves only two methods of taking SP + MC: the day-before and split-dose preparation, without approval of same-day preparations. This study aimed to evaluate the efficacy and safety of same-day SP + MC preparations. METHODS: This was a multicenter, single-arm, nonrandomized, open-label study. We enrolled 145 Japanese patients between June and December 2023. The patients received two sachets of SP + MC dissolved in 300 ml of water and 1200 mL or more of clear liquid on the day of colonoscopy. Bowel cleansing efficacy, adverse events (AEs), and patient satisfaction were evaluated. RESULTS: Of the enrolled patients, 137 underwent colonoscopy according to our protocol. Bowel preparation was adequate in 133 patients (97.1%). The mean total Boston Bowel Preparation Score was 8.3 ± 1.2. Five patients experienced AEs (3.6%): two (1.5%), abdominal pain; one (0.73%), ischemic enteritis; one (0.73%), vomiting or nausea; and one (0.73%), headache. All AEs were treated conservatively. None of the patients exhibited abnormal blood test results or clinical symptoms after receiving SP + MC. Regarding patient satisfaction, all patients were able to take SP + MC as directed; 136 (99.2%) expressed a preference for this bowel preparation for future colonoscopies. CONCLUSION: The same-day SP + MC preparation showed high bowel-cleansing efficacy and satisfaction in Japanese patients without serious AEs.

Characteristics of Gastric Stasis due to Deformation after Endoscopic Submucosal Dissection in the Lower Part of the Stomach.

INTRODUCTION: Gastric stasis due to deformation occurs after endoscopic submucosal dissection in the lower part of the stomach. Endoscopic balloon dilation can improve gastric stasis due to stenosis; however, endoscopic balloon dilation cannot improve gastric stasis due to deformation. Furthermore, the characteristics of gastric stasis due to deformation are unknown. This study aimed to evaluate the characteristics of gastric stasis due to deformation after endoscopic submucosal dissection in the lower part of the stomach, focusing on the differences between stenosis and deformation. METHODS: We retrospectively reviewed 41 patients with gastric stasis after endoscopic submucosal dissection in the lower part of the stomach. We evaluated the characteristics of cases with gastric stasis due to deformation, such as the risk factors of deformation and the rate of deformation in each group with risk factors. RESULTS: Deformation was observed in 12% (5/41) of the patients with gastric stasis. All cases of deformation had a circumferential extent of the mucosal defect greater than 3/4. The number of cases with pyloric dissection was significantly lower in the deformation group than in the non-deformation group (0% vs. 72%; p = 0.004). The deformation group also had a significantly higher number of cases with angular dissection than the non-deformation group (100% vs. 17%; p < 0.001). Moreover, the deformation cases had a significantly larger specimen diameter (p < 0.001). Deformation was observed only in cases with angular and non-pyloric dissections. Deformation was not observed in cases with angular and pyloric dissections. CONCLUSIONS: All cases of gastric stasis due to deformation had a circumferential extent of the mucosal defect greater than 3/4. Deformation was also likely to occur in cases with a larger dissection that exceeded the angular region without pyloric dissection.

Risk-scoring system for predicting challenging cases of peroral endoscopic myotomy.

OBJECTIVES: Peroral endoscopic myotomy (POEM) is an effective treatment for esophageal motility disorders including achalasia and its variants. However, some surgeons have encountered challenging cases. This study aimed to develop a risk-scoring system to predict challenging cases of POEM. METHODS: Consecutive patients who underwent POEM between April 2015 and March 2020 at our hospital were included in this single-center retrospective study. Challenging cases of POEM were defined as patients with any of the following: (i) procedure time ≥90 min; (ii) mucosal perforation; (iii) pneumothorax; and (iv) major bleeding. A risk-scoring system for predicting challenging cases was developed based on multivariate logistic regression and internal validation was performed using the bootstrap method. Clinical usefulness was evaluated using a decision curve analysis. RESULTS: Of the 467 patients, 59 (12.6%) had challenging POEM. A risk-scoring system consisted of four variables: duration of symptoms ≥5 years (assigned score, 1 point), antithrombotics use (1 point), manometric diagnosis of achalasia variants (2 points), and dilation grade 3 (2 points). Our scoring system showed satisfactory discrimination (area under the receiver operating characteristic curve, 0.69; 95% confidence interval [CI] 0.61-0.77) and calibration (slope, 0.99; 95% CI 0.65-1.35). The decision curve analysis demonstrated its clinical usefulness. CONCLUSIONS: We established a risk-scoring system to predict challenging cases of POEM. This scoring system may aid the selection of patients who require treatment from experienced surgeons.

Predicting Inadequate Bowel Preparation When Using Sodium Picosulfate plus Magnesium Citrate for Colonoscopy: Development and Validation of a Prediction Score.

INTRODUCTION: Sodium picosulfate plus magnesium citrate is a bowel preparation agent with high patient acceptability. However, it is unclear which patients are more likely to have inadequate bowel preparation when using this agent. This study aimed to identify the risk factors for inadequate bowel preparation when using sodium picosulfate plus magnesium citrate for colonoscopy and to develop a scoring model to predict which patients will have inadequate bowel preparation. METHODS: A total of 350 Japanese patients were enrolled from June 2021 to April 2022. Data on patient background, details of colonoscopy, and satisfaction assessment questionnaire results were prospectively collected. The scoring model for inadequate bowel preparation was developed based on multiple logistic regression analyses, and its performance was internally validated using bootstrapping. RESULTS: Adequate bowel preparation was obtained in 295 patients (84.3%); 335 (95.7%) were able to ingest the drug without difficulty. The scoring model consisted of five independent risk factors and points of risk scores were assigned to each one as follows: American Society of Anesthesiologists physical status III (1 point), diabetes comorbidities (5 points), use of laxatives (4 points), no defecation once in a day (2 points), and drug use for mental disorder (6 points). The C-statistics of the scoring system for inadequate bowel preparation was 0.75. DISCUSSION: We identified five risk factors for inadequate bowel preparation when using sodium picosulfate plus magnesium citrate regimen and developed a scoring model for inadequate bowel preparation with satisfactory discrimination and calibration.

Esophageal motility disorders missed during endoscopy.

BACKGROUND: Esophageal motility disorders are sometimes misdiagnosed on endoscopic examination. We aimed to identify the proportion of patients with esophageal motility disorders missed during endoscopy and their clinical characteristics. METHODS: Patients diagnosed with either disorder with esophagogastric junction outflow obstruction or major disorders of peristalsis using high-resolution manometry in our hospital from April 2015 to March 2021 were included in this study. Missed esophageal motility disorders were defined as patients with any endoscopic misdiagnosis such as normal esophagus or esophagitis within 1 year before the manometric diagnosis. We determined the proportion of missed esophageal motility disorders and identified independent predictors of missed esophageal motility disorders using multivariate analysis. RESULTS: A total of 41/273 esophageal motility disorders (15.0%; 95% confidence interval 11.3-19.7%) were missed during endoscopy within 1 year before manometric diagnosis. In the stepwise logistic regression analysis, the following variables were selected as independent variables for patients with missed esophageal motility disorders during endoscopy: non-dilated esophagus (odds ratio = 4.87, 95% confidence interval: 1.81-13.12, p = 0.002), the presence of epiphrenic diverticulum (odds ratio = 8.95, 95% confidence interval: 1.88-42.65, p = 0.006), the use of transnasal endoscopy (odds ratio = 4.71, 95% confidence interval: 1.59-13.92, p = 0.005), and the combined use of esophagram (odds ratio = 0.023, 95% confidence interval: 0.0025-0.20, p = 0.0008). CONCLUSIONS: Based on retrospective analysis, 15% of esophageal motility disorders were missed during endoscopy. Understanding the clinical characteristics of missed esophageal motility disorders could help improve endoscopic diagnoses.

Timing of pyloric stenosis and effectiveness of endoscopic balloon dilation after pyloric endoscopic submucosal dissection.

BACKGROUND AND AIM: There have been studies on risk factors for stenosis after pyloric endoscopic submucosal dissection (ESD). However, the most appropriate strategies for the management of cases with these risk factors have not been established. This study aimed to investigate post-ESD management by evaluating the timing of stenosis and the effectiveness of endoscopic balloon dilation (EBD) after pyloric ESD. METHODS: We retrospectively reviewed cases of pyloric ESD. We first reassessed risk factors for stenosis in multivariate analysis and receiver operating characteristic curve and defined patients with the identified risk factors as the risk group. The primary outcome was the timing of stenosis in the risk group assessed by the Kaplan-Meier method. RESULTS: We reviewed 159 cases with pyloric ESD and observed pyloric stenosis in 25 cases. Cases with circumferential mucosal defect ≥ 76% were identified as the risk group. The stenosis-free probability in the risk group was 97% (95% confidence interval [CI]: 79-100%), 94% (95% CI: 76-98%), and 85% (95% CI: 66-93%) on days 7, 14, and 21, respectively. It decreased every week thereafter and did not significantly change after day 56. Twenty-three stenosis cases, except for conservative improvement, including six whole circumferential pyloric ESD cases, were improved by EBD without complications. CONCLUSIONS: Post-ESD stenosis often developed from the third to the eighth week. In all pyloric ESD cases, including whole circumferential pyloric ESD cases, pyloric stenosis was improved following EBD without complications.

Comparison of the safety and efficacy of peroral endoscopic myotomy between octogenarians and non-octogenarians.

OBJECTIVES: This study compared the safety and efficacy of peroral endoscopic myotomy for esophageal motility disorders between octogenarians and non-octogenarians. METHODS: This retrospective observational study recruited 321 patients (28 octogenarians and 293 non-octogenarians) who underwent peroral endoscopic myotomy from two institutions. Clinical success (postoperative Eckardt score ≤ 3), technical success (completion of gastric and esophageal myotomy), and perioperative adverse events were compared between octogenarians and non-octogenarians. Perioperative adverse events were classified into major and minor adverse events based on the International Peroral Endoscopic Myotomy Survey criteria and were subdivided into technical and non-technical adverse events according to the presence of a direct causal relationship with the procedure. RESULTS: There were no significant differences in the rates of clinical success 1 year after treatment (100% vs. 97.3%, P = 0.64) and technical success (100% vs. 99.7%, P = 0.91) between octogenarians and non-octogenarians. Octogenarians had a higher incidence of perioperative adverse events (28.6% vs. 10.2%, P = 0.00097), particularly major adverse events (25.0% vs. 3.0%, P < 0.0001). There were no significant differences in the incidence of minor adverse events (7.1% vs. 7.9%, P = 0.67). Although there was no difference in the incidence of technical adverse events (10.7% vs. 9.2%, P = 0.74), octogenarians had a significantly higher incidence of non-technical adverse events (17.9% vs. 1.0%, P = 0.0002). CONCLUSIONS: There were no significant differences in short-term clinical success and technical success between octogenarians and non-octogenarians. However, octogenarians showed a significantly higher incidence of perioperative adverse events, particularly in major adverse events and non-technical adverse events. Peroral endoscopic myotomy for octogenarians should be carefully applied.

Peroral endoscopic myotomy for advanced achalasia with megaesophagus.

BACKGROUND: The outcomes of peroral endoscopic myotomy for advanced achalasia are not well known. This study aimed to evaluate the outcomes of peroral endoscopic myotomy for achalasia with megaesophagus, which is one of the characteristics of advanced achalasia. METHODS: In total, 234 patients with achalasia who underwent peroral endoscopic myotomy in our hospital from April 2015 to March 2019 were included in this retrospective observational study. Megaesophagus was defined as a maximum esophageal diameter of 6 cm or more. Outcomes, including clinical success (Eckardt score ≤ 3 without retreatment) at the 1-year follow-up, technical success, and perioperative complications, were investigated and compared between patients with and without megaesophagus. RESULTS: Eleven patients (4.7%) were diagnosed with megaesophagus. The clinical success rate achieved was 63.6% in patients with megaesophagus, with a significant decrease in the Eckardt score (6 vs. 2, p = 0.003) and integrated relaxation pressure (28 mmHg vs. 9 mmHg, p = 0.028). The technical success rate was 100%. However, patients with megaesophagus had a significantly lower clinical success rate than those without megaesophagus (63.6% vs. 96.0%, p = 0.002). Furthermore, patients with megaesophagus had significantly higher rates of major adverse events than those without megaesophagus (18.2% vs. 2.7%, p = 0.048). CONCLUSIONS: Peroral endoscopic myotomy improved achalasia-related symptoms, and this was technically feasible in patients with megaesophagus. However, the clinical success rate was somewhat low, and the rate of major adverse events was high. Therefore, peroral endoscopic myotomy should be carefully performed for advanced achalasia with megaesophagus.

Peroral endoscopic myotomy alone is effective for esophageal motility disorders and esophageal epiphrenic diverticulum: a retrospective single-center study.

BACKGROUND: Esophageal epiphrenic diverticulum (ED) is associated with esophageal motility disorder (EMD). If a diverticulum associated with EMD is enlarging with worsening symptoms, surgical intervention, including laparoscopic epiphrenic diverticulectomy with myotomy and fundoplication, is indicated. However, some studies suggest that myotomy alone, with less adverse events, is sufficient to improve symptoms. Additionally, peroral endoscopic myotomy (POEM) is considered effective and safe for EMD. Since theoretically, POEM is endoscopic Heller myotomy, POEM without diverticulectomy is considered a less invasive, promising treatment option for EMD and ED. We aimed to determine the efficacy and safety of POEM alone for ED with EMD. METHODS: This single-center study was retrospective. A total of 298 patients underwent POEM in Kobe University Hospital from April 2015 to October 2018. Of them, 14 patients had ED. Procedure-related outcomes and treatment outcomes 3 months post POEM were evaluated in these patients. RESULTS: The median maximum ED diameter was 29 (range 9-90) mm; and the median POEM procedure time, 77.5 (range 41-123) min. Pneumoperitoneum, which required needle decompression, occurred in one patient, but no fatal adverse events occurred. The median Eckardt score significantly decreased from 5 [range 2-11] pre POEM to 0 [range 0-2] post POEM (P < 0.0001). The median integrated relaxation pressure significantly decreased from 22.5 [13.9-34.3] mmHg pre POEM to 10.2 [0.7-23.9] mmHg post POEM (P < 0.0001). Of 14 patients, only one patient complained of gastroesophageal reflux disease symptoms, which could be controlled with a potassium-competitive acid blocker. CONCLUSIONS: POEM alone seemed effective and safe for patients with EMD and ED.

Endoscopic plombage with polyglycolic acid sheets and fibrin glue for gastrointestinal fistulas.

BACKGROUND AND STUDY AIMS: Gastrointestinal (GI) fistulas arise as adverse events of GI surgery and endoscopic treatment as well as secondary to underlying diseases, such as ulceration and pancreatitis. Until a decade ago, they were mainly treated surgically or conservatively. Bioabsorbable polyglycolic acid (PGA) sheets and fibrin glue, which are commonly used in surgical procedures, have also recently been used in endoscopic procedures for the closure of GI defects. However, there have only been few case reports about successful experiences with this approach. There have not been any case-series studies investigating the strengths and weaknesses of such PGA sheet-based treatment. In this study, we evaluated the clinical effectiveness of using PGA sheets to close GI fistulas. PATIENTS AND METHODS: Cases in which patients underwent endoscopic filling with PGA sheets and fibrin glue for GI fistulas at Kobe University Hospital between January 2013 and April 2018 were retrospectively reviewed. RESULTS: A total of 10 cases were enrolled. They included fistulas due to leakage after GI surgery, aortoesophageal/bronchoesophageal fistulas caused by chemoradiotherapy, or severe acute pancreatitis. The fistulas were successfully closed in 7 cases (70%). The unsuccessful cases involved a fistula due to leakage after surgical esophagectomy and bronchoesophageal fistulas due to chemoradiotherapy or severe acute pancreatitis. Unsuccessful treatment was related to fistula epithelization. CONCLUSION: Endoscopic plombage with PGA sheets and fibrin glue could be a promising therapeutic option for GI fistulas.

Effective treatment improves the body composition of patients with esophageal motility disorders.

Although treatment for esophageal motility disorder improves dysphagia and increases body weight, the effect of the treatment on body composition is unclear. This study aimed to assess the change in body composition between before and after treatment, the preoperative predictors of muscle increase, and the association between muscle increase and quality of life. Sixty-one patients (achalasia, n = 55; spastic esophageal disorder n = 6) who underwent per-oral endoscopic myotomy were analyzed in a single-arm prospective observational study. Appendicular skeletal muscle mass was measured with dual X-ray absorptiometry before and 3 months after per-oral endoscopic myotomy. For subgroup analysis, patients with postoperative appendicular skeletal muscle mass increase were defined as the muscle-increase group and the rest as the non-muscle-increase group. Preoperative factors related to the muscle-increase group were clarified via multivariate analysis. Further, the improvement after per-oral endoscopic myotomy in health-related quality-of-life score (Short Form-36) was compared between the muscle-increase and non-muscle-increase groups. Appendicular skeletal muscle mass increased significantly 3 months after per-oral endoscopic myotomy (P = 0.0002). The patients who underwent effective treatment (postoperative Eckardt score < 3) showed a significant improvement in appendicular skeletal muscle mass compared to those who did not (P = 0.04). In the stepwise logistic regression analysis, the preoperative Eckardt score (odds ratio: 1.95, 95% confidence interval 1.30-3.26, P = 0.0005) and preoperative serum prealbumin (odds ratio: 0.83, 95% confidence interval 0.70-0.97, P = 0.02) were identified as independent factors related to postoperative muscle increase. The improvements in the Short Form-36 domains of General Health (P = 0.0007) and Vitality (P = 0.003) were significantly higher in the muscle-increase group. The findings show that effective treatment improved the body composition of patients with esophageal motility disorder and that the Eckardt score and serum prealbumin may aid the prediction of increased appendicular skeletal muscle mass after treatment, resulting in a better quality of life.

Peroral Endoscopic Myotomy in Pediatric Patients with Achalasia up to 12 Years of Age: A Pilot Study in a Single-Center Experience in Japan.

INTRODUCTION: Peroral endoscopic myotomy (POEM) is a minimally invasive endoscopic procedure for achalasia; its indication has expanded from adults to children. We aimed to evaluate the postoperative efficacy and antireflex status of POEM in young children with achalasia aged 12 years or younger. PATIENTS: AND METHODS: Pediatric patients with achalasia aged 18 years or younger who underwent POEM in our hospital between 2016 and 2021 were included and divided into two age groups: group A (≤ 12 years) and group B (13-18 years). The success rate (Eckardt score ≤ 3), endoscopic reflux findings, and antiacid use at 1 year postoperatively were compared between the groups. RESULTS: Ten patients (four boys and six girls; Chicago classification type I: five, type II: four, and unclassified: one) were included. Mean age and preoperative Eckardt scores in groups A (n = 4) and B (n = 6) were 9.2 ± 3.0 versus 15.6 ± 0.6 years (p = 0.001) and 5.5 ± 3.9 versus 7.2 ± 3.7 (p = 0.509), respectively, and mean operative time and myotomy length were 51.3 ± 16.6 versus 52.5 ± 13.2 minutes (p = 0.898) and 10.8 ± 4.6 versus 9.8 ± 3.2 cm (p = 0.720), respectively. The 1-year success rate was 100% in both groups. Mild esophagitis (Los Angeles classification B) was endoscopically found in one patient in each group (16.7 vs. 25.0%, p = 0.714), and antiacid use was required in three patients (group A, two; group B, one; 50.0 vs. 16.7%, p = 0.500). CONCLUSION: The success rate of POEM within 1 year in young children with achalasia aged 12 years or younger was equal to that in adolescent patients. However, young children tended to require antiacids 1 year postoperatively; therefore, long-term follow-up is necessary.

Randomised controlled, patient-blinded, multicentre, superiority trial to evaluate the efficacy of the line-attached sheath-type traction device for endoscopic submucosal dissection in patients with superficial gastric neoplasms.

INTRODUCTION: EndoTrac is a line-attached sheath-type traction device that enables us to control the direction and the force of traction during endoscopic submucosal dissection (ESD). The efficacy of EndoTrac for gastric ESD has not been fully verified. METHODS AND ANALYSIS: The G-Trac study is a multicentre (nine general hospitals and two university hospitals in Japan) collaborative trial assessing the efficacy of EndoTrac for gastric ESDs. Patients with superficial gastric neoplasms will be enrolled and randomly assigned to undergo either conventional ESD or EndoTrac ESD. Allocation will be stratified according to tumour location, operator experience and tumour diameter at an allocation rate of 1:1. The type of endoknife used will be confirmed before randomisation. The primary outcome, procedure time, will be compared between the groups in both intention-to-treat and per-protocol analyses using the Wilcoxon rank sum test. The efficacy-related, safety-related and device-related outcomes will be assessed in the secondary analysis. The planned sample size of the 142 patients in the two groups will enable us to detect a difference with a power of 80% by using the Wilcoxon rank sum test, assuming an effect size of 0.54, asymptotic relative efficiency of 0.864 and a two-sided type 1 error rate of 5%. ETHICS AND DISSEMINATION: This trial was approved by the certified review board of Kobe University (22 December 2022). The results from this trial will be disseminated through peer-review journals, presentations at national and international conferences, and data sharing with other researchers. TRIAL REGISTRATION NUMBER: jRCT1052220166.