OBJECTIVE: The endoscopic pressure study integrated system (EPSIS) is an endoscopic diagnostic system utilized for evaluation of lower esophageal sphincter function. Although previous studies have determined that EPSIS was effective as a tool for the diagnosis of achalasia, it remains uncertain if EPSIS can detect significant changes before and after peroral endoscopic myotomy (POEM), which is the premier treatment for achalasia. This study aimed to evaluate the effectiveness of EPSIS as an objective diagnostic tool for assessing the clinical effect of POEM.
METHODS: We conducted a retrospective analysis of patients who underwent POEM from January 2022 to December 2023. The patients underwent EPSIS preoperatively and 2 months postoperatively. Intragastric pressure (IGP) parameters, including the maximum IGP, IGP difference, and waveform gradient were compared pre- and post-POEM. These parameters also were compared between two groups: the postoperative gastroesophageal reflux disease (GERD) group and the non-GERD group.
RESULTS: A total of 50 patients were analyzed. The mean maximum IGP was significantly lower postoperatively than preoperatively (15.0 mmHg vs. 19.8 mmHg, P < 0.001). The mean IGP difference and waveform gradient were also significantly lower postoperatively than preoperatively (8.0 mmHg vs. 12.2 mmHg, P < 0.001; and 0.26 mmHg/s vs. 0.43 mmHg/s, P < 0.001, respectively). The mean postoperative waveform gradient was significantly lower in the GERD group (17 patients, 34%) than in the non-GERD group (33 patients, 66%) (0.207 mmHg vs. 0.291 mmHg, P = 0.034).
CONCLUSIONS: The results supported the use of EPSIS as an effective diagnostic tool for assessing the effect of POEM.

BACKGROUND: Longitudinal incision is the commonly used incision for entry into the submucosal space during peroral endoscopic myotomy (POEM) for esophageal motility disorders. Transverse incision is another alternative for entry and retrospective data suggest it has less operative time and chance of gas-related events.
METHODS: This was a single-center, randomized trial conducted at a tertiary care hospital. Patients undergoing POEM for esophageal motility disorders were randomized into group A (longitudinal incision) and group B (transverse incision). The primary objective was to compare the time needed for entry into the submucosal space. The secondary objectives were to compare the time needed to close the incision, number of clips required to close the incision, and development of gas-related events. The sample size was calculated as for a non-inferiority design using Kelsey method.
RESULTS: Sixty patients were randomized (30 in each group). On comparing the 2 types of incisions, there was no difference in entry time [3 (2, 5) vs 2 (1.75, 5) min, p = 0.399], closure time [7 (4, 13.5) vs 9 (6.75, 19) min, p = 0.155], and number of clips needed for closure [4 (4, 6) vs 5 (4, 7), p = 0.156]. Additionally, the gas-related events were comparable between the 2 groups (capnoperitoneum needing aspiration-5 vs 2, p = 0.228, and development of subcutaneous emphysema-3 vs 1, p = 0.301).
CONCLUSIONS: This randomized trial shows comparable entry time, closure time, number of clips needed to close the incision, and gas-related events between longitudinal and transverse incisions.
BACKGROUND: CTRI/2021/08/035829.

Opioid-induced esophageal dysfunction (OIED) often presents as spastic esophageal disorders (SEDs) and esophagogastric junction outflow obstruction (EGJOO). The aim of this study was to evaluate and compare clinical outcomes of peroral endoscopic myotomy (POEM) for SEDs and EGJOO among opioid users and nonusers.
This propensity score (PS) matching study included consecutive opioid users and nonusers who underwent POEM for SEDs and EGJOO between January 2018 and September 2022. The following covariates were used for the PS calculation: age, sex, duration of symptoms, Eckardt score, type of motility disorder, and length of myotomy during POEM. Clinical response was defined as a post-POEM Eckardt score ≤3.
A total of 277 consecutive patients underwent POEM during the study period. PS matching resulted in the selection of 64 pairs of patients strictly matched 1:1 (n = 128) with no statistically significant differences in demographic, baseline, or procedural characteristics or in the parameters considered for the PS between the 2 groups. Clinical response to POEM was significantly lower among opioid users (51 of 64 [79.7%]) versus nonusers (60 of 64 [93.8%]) (P = .03) at a median follow-up of 18 months. Among opioid users, higher opioid dose (>60 morphine milligram equivalents per day) was associated with a higher likelihood of failure to respond to POEM (odds ratio, 4.59; 95% confidence interval, 1.31-3.98; P = .02).
Clinical response to POEM for SEDs and EGJOO is significantly lower among opioid users versus nonusers. There was a dose-relationship between opioids and response to POEM, with higher daily opioid usage associated with a higher likelihood of treatment failure.

The symptoms of reflux in achalasia patients undergoing peroral endoscopic myotomy (POEM) are believed to result from gastroesophageal reflux, and the current treatment primarily focuses on acid suppression. Nevertheless, other factors such as nonreflux acidification caused by fermentation or stasis might play a role. This study aimed to identify patients with \"true acid reflux\" who actually require acid suppression and fundoplication.
In this prospective large cohort study, the primary objective was to assess the incidence and risk factors for true acid reflux in achalasia patients undergoing POEM. Acid reflux with normal and delayed clearance defined true acid reflux, whereas other patterns were labeled as nonreflux acidification patterns on manual analysis of pH tracings. These findings were corroborated with a symptom questionnaire, esophagogastroscopy, esophageal manometry, and timed barium esophagogram at 3 months after the POEM procedure.
Fifty-four achalasia patients aged 18 to 80 years (mean age, 41.1 ± 12.8 years; 59.3% men; 90.7% with type II achalasia) underwent POEM, which resulted in a significant mean Eckardt score improvement (6.7 to 1.6, P < .05). True acid reflux was noted in 29.6% of patients as compared with 64.8% on automated analysis. Acid fermentation was the predominant acidification pattern seen in 42.7% of patients. On multivariable logistic regression analysis, increasing age (odds ratio, 1.12; 95% confidence interval, 1.02-1.27; P = .04) and preprocedural integrated relaxation pressure (IRP; odds ratio, 1.13; 95% confidence interval, 1.04-1.30; P = .02) were significantly associated with true acid reflux in patients after undergoing POEM.
A manual review of pH tracings helps to identify true acid reflux in patients with achalasia after undergoing POEM. Preprocedural IRP can be a predictive factor in determining patients at risk for this outcome. (Clinical trial registration number: NCT04951739.).

UNASSIGNED: Atopic dermatitis (AD) management requires long-term use of drugs that come with side effects. Compounds such as xyloglucan (XG) and pea proteins (PP) are emerging alternatives to corticosteroids that have shown to restore skin barrier function in preclinical studies. This double-blind, parallel, randomized, placebo-controlled clinical trial investigated the efficacy and safety of XG and PP, in adult AD patients.
UNASSIGNED: Fourty-two patients with AD were randomly assigned 1:1 to receive a XG+PP treatment or the vehicle without XG+PP twice/day for 14 consecutive days for assessment at baseline, Day 8 and Day 15; follow-up visit was 14 days after the end of treatment (Day 28). Efficacy was evaluated using the Scoring Atopic Dermatitis (SCORAD) index, AD severity index (ADSI) score and patient-oriented eczema measure (POEM). Safety and tolerability were monitored as the occurrence of Adverse Events (AEs).
UNASSIGNED: At baseline, both groups exclusively included moderate/severe AD cases. At Day 8, six patients treated with XG+PP displayed complete resolution of AD, while 15 patients had mild AD. At Day 28, 16 patients no longer had eczema, whereas five patients displayed mild AD. Notably, 21 patients in the vehicle group still displayed moderate/severe AD.
UNASSIGNED: XG and PP promote rapid and long-lasting relief, supporting its use as a safe alternative to mainstay corticosteroid treatments for AD management. The study protocol has been registered in the ISRCTN registry (TN66879853).

Peroral endoscopic myotomy (POEM) is a very effective treatment for achalasia. However, training remains non-standardized. We evaluated a training curriculum, including ex vivo cases, followed by patients\' cases under expert supervision. The objective was to establish a learning curve of POEM.
Four operators having completed advanced endoscopy fellowship were involved. They had already observed > 30 cases performed by experts. They performed 30 POEMs standardized (tunnel and myotomy lengths) procedures on ex vivo porcine model. Procedural times, number/volume of injections, mucosal and serous perforations, and myotomy length were collected. The learning curve was assessed using dissection speed (DS) and a dedicated performance score (PS), including learning rate (LR) and learning plateau (LP).
The operators completed all cases within 4 months (median of 3.5 cases/week). The mean procedural time was 43.3 min ± 14.4. Mean myotomy length was 70.0 mm ± 15.6 mm. Dissection speed averaged 1.78 mm/min ± 0.78. Using DS and PS as parameter, the LR was reached after 12.2 cases (DS = 2.0 mm/min) and 10.4 cases, respectively. When comparing the LP and the plateau phase, the DS was slower (1.3 ± 0.5 mm/min versus 2.1 ± 0.54 mm/min, p < 0.005) and perforations were decreased: 0.35 ± 0.82 in LP vs. 0.16 ± 0.44 in PP. Following this training, all operators performed 10 supervised cases and are competent in POEM.
The association of observed cases and supervised ex vivo model training is effective for starting POEM on patients. The learning curve is 12 cases to reach a plateau.

UNASSIGNED: Although usually mild to moderate in severity, postoperative pain after peroral endoscopic myotomy (POEM) is common. There are no studies that have addressed minimizing postoperative pain in patients undergoing POEM for achalasia. We hypothesized that intraoperative topical intra-tunnel irrigation with ropivacaine would result in a significant reduction in pain scores in the postoperative period.
UNASSIGNED: A double-blind, randomized, placebo-controlled trial was conducted at the Kingston Health Sciences Center. Patients received either 30 mL of 0.2% ropivacaine or 30 mL of placebo irrigated topically into the POEM tunnel after completing the myotomy and prior to closing the mucosal incision. The primary outcome was pain post-POEM at 6 h assessed by the Numeric Rating Scale (NRS). Secondary objectives included assessing pain score at 0.5, 1, 2, 4 h post-POEM and on discharge, Quality of Recovery (QoR-15) scores at discharge, narcotic requirement, adverse events, and patients\' willingness to have the procedure done on an outpatient basis.
UNASSIGNED: A total of 20 patients were enrolled. For the primary outcome of pain post-POEM at 6 h, the NRS was 1.1 in the placebo group and 2.4 in the ropivacaine group (95% CI of the difference: -3.2 to 0.6, P = 0.171). No statistical difference was seen in the pain scores. Overall usage of post-procedural narcotics was low with no differences between the two groups. Fifty percent of patients in both groups were willing to have the procedure done as an outpatient.
UNASSIGNED: The addition of intra-procedural tunnel irrigation with 30 mL 0.2% ropivacaine did not lead to reduced post-POEM pain.

POEM has recently had a widespread diffusion, aiming at being the treatment of choice for esophageal achalasia. The results of ongoing RCTs against laparoscopic myotomy are not available, yet. We, therefore, designed this propensity score (PS) case-control study with the aim of evaluating how POEM compares to the long-standing laparoscopic Heller myotomy + Dor fundoplication (LHD) and verifying if it may really replace the latter as the first-line treatment for achalasia.
Two groups of consecutive patients undergoing treatment for primary achalasia from January 2014 to November 2017 were recruited in two high-volume centers, one with extensive experience with POEM and one with LHD. Patients with previous endoscopic treatment were included, whereas patients with previous LHD or POEM were excluded. A total of 140 patients in both centers were thus matched. LHD and POEM were performed following established techniques. The patients were followed with clinical (Eckardt score), endoscopic, and pH-manometry evaluations.
The procedure was successfully completed in all the patients. POEM required a shorter operation time and postoperative stay compared to LHD (p < 0.001). No mortality was recorded in either group. Seven complications were recorded in the POEM group (five mucosal perforations) and 3 in the LHD group (3 mucosal perforations)(p = 0.33). Two patients in the POEM group and one in the LHD were lost to follow-up. One patient in both groups died during the follow-up for unrelated causes. At a median follow-up of 24 months [15-30] for POEM and 31 months [15-41] for LHD (p < 0.05), 99.3% of the POEM patients and 97.7% of the LHD patients showed an Eckardt score ≤ 3 (p < 0.12). Four years after the treatment, the probability to have symptoms adequately controlled was > 90% for both groups (p = 0.2, Log-rank test). HR-Manometry showed a similar reduction in the LES pressure and 4sIRP; 24-h pH-monitoring showed however an abnormal exposure to acid in 38.4% of POEM patients, as compared to 17.1% of LHD patients (p < 0.01) and esophagitis was found in 37.4% of the POEM and 15.2% of LHD patients (p < 0.05).
POEM provides the same midterm results as LHD. This study confirms, however, a higher incidence of postoperative GERD with the former, even if its real significance needs to be further evaluated.

BACKGROUND: Patient-reported outcomes measures in clinical trials ensure that evaluations of effectiveness focus on outcomes that are important to patients. In relapsing-remitting conditions, such as eczema, repeated measurements may allow a more accurate reflection of disease burden and treatment effect than less frequent measurements. We asked parents/carers of children with eczema taking part in a trial of bath emollients to complete weekly questionnaires for 16 weeks.
METHODS: The objective of this study was to determine the acceptability and practicality of collecting weekly measures of eczema severity online for 16 weeks in children aged 1 to 11 years as part of the BATHE study. BATHE randomised patients to bath emollients plus standard eczema care or standard eczema care only. The primary outcome was eczema severity, measured by the seven-item Patient-Oriented Eczema Measure (POEM) repeated weekly for 16 weeks. Acceptability was explored through qualitative interviews with 10 participants. Interviews were audio-recorded, transcribed and analysed thematically. Practicality was assessed by exploring the completeness of the data and keeping a log of any problems.
RESULTS: Four hundred and eighty-two participants were recruited to the trial and 429 opted to complete measures online (89.0%). Data were collected online for 83% of time points over the 16-week period and there was no association between socio-demographic characteristics and data completeness. Two hundred and six (48%) completed their weekly data every week for 16 weeks and 341 (79%) completed it at least 80% of the time. The mean number of weeks completed was 13.3 out of 16 (SD 4.2). Interviewees said that they understood the rationale behind weekly collection and some welcomed this as it helped them realise how their child\'s eczema changed weekly. Whilst some interviewees spoke of weekly questionnaires as onerous, others said that they found them quick and easy. Reminders were welcomed. Parents/carers seemed happy to receive telephone reminders and it was sometimes useful for eliciting problems relating to obtaining trial medication or password problems for online data collection.
CONCLUSIONS: Amongst this population, high levels of data completeness suggests that weekly completion of the online questionnaire appears to be acceptable and feasible over a 16-week period.
BACKGROUND: ISRCTN84102309 . Registered on 9 December 2013.

Obtaining an adequate mucosal closure is one of the crucial steps in per-oral endoscopic myotomy (POEM). Thus far, there have been no objective data comparing the various available closure techniques. This case-controlled study attempts to compare the application of endoscopic clips versus endoscopic suturing for mucosotomy closure during POEM cases.
A retrospective review of our prospective POEM database was performed. All cases in which endoscopic suturing was used to close the mucosotomy were matched to cases in which standard endoclips were used. Overall complication rate, closure time and mucosal closure costs between the two groups were compared.
Both techniques offer good clinical results with good mucosal closure and the absence of postoperative leak. Closure time was significantly shorter (p = 0.044) with endoscopic clips (16 ± 12 min) when compared to endoscopic suturing (33 ± 11 min). Overall, the total closure cost analysis showed a trend toward lower cost with clips (1502 ± 849 USD) versus endoscopic suturing (2521 ± 575 USD) without reaching statistical significance (p = 0.073).
The use of endoscopic suturing seems to be a safe method for mucosal closure in POEM cases. Closure time is longer with suturing than conventional closure with clips, and there is a trend toward higher overall cost. Endoscopic suturing is likely most cost-effective for difficult cases where conventional closure methods fail.