The Efficacy of Peroral Endoscopic Myotomy vs Pneumatic Dilation as Treatment for Patients With Achalasia Suffering From Persistent or Recurrent Symptoms After Laparoscopic Heller Myotomy: A Randomized Clinical Trial.

BACKGROUND & AIMS: For patients with achalasia experiencing persistent or recurrent symptoms after laparoscopic Heller myotomy (LHM), pneumatic dilation (PD) is the most frequently used treatment. Per-oral endoscopic myotomy (POEM) is increasingly being investigated as rescue therapy. This study aimed to determine the efficacy of POEM vs PD for patients with persistent or recurrent symptoms after LHM. METHODS: This randomized multicenter controlled trial included patients after LHM with an Eckardt score >3 and substantial stasis (≥2 cm) on timed barium esophagogram and randomized to POEM or PD. The primary outcome was treatment success, defined as an Eckardt score of ≤3 and without unscheduled re-treatment. Secondary outcomes included the presence of reflux esophagitis, high-resolution manometry, and timed barium esophagogram findings. Follow-up duration was 1 year after initial treatment. RESULTS: Ninety patients were included. POEM had a higher success rate (28 of 45 patients [62.2%]) than PD (12 of 45 patients [26.7%]; absolute difference, 35.6%; 95% CI, 16.4%-54.7%; P = .001; odds ratio, 0.22; 95% CI, 0.09-0.54; relative risk for success, 2.33; 95% CI, 1.37-3.99). Reflux esophagitis was not significantly different between POEM (12 of 35 [34.3%]) and PD (6 of 40 [15%]). Basal lower esophageal sphincter pressure and integrated relaxation pressure (IRP-4) were significantly lower in the POEM group (P = .034; P = .002). Barium column height after 2 and 5 minutes was significantly less in patients treated with POEM (P = .005; P = .015). CONCLUSIONS: Among patients with achalasia experiencing persistent or recurrent symptoms after LHM, POEM resulted in a significantly higher success rate than PD, with a numerically higher incidence of grade A-B reflux esophagitis. NETHERLANDS TRIAL REGISTRY: NL4361 (NTR4501), https://trialsearch.who.int/Trial2.aspx?TrialID = NTR4501.

Focal Distal Esophageal Dilation (Blown-Out Myotomy) After Achalasia Treatment: Prevalence and Associated Symptoms.

INTRODUCTION: Peroral endoscopic myotomy (POEM) may result in a distended distal esophagus, referred to as a blown-out myotomy (BOM), the relevance of which is uncertain. The aim of this study was to investigate the prevalence, risk factors, and associated symptoms of BOM after achalasia treatment. METHODS: A data set of the locally treated patients in a randomized controlled trial comparing POEM with pneumatic dilation (PD) was analyzed. A BOM is defined as a >50% increase in esophageal diameter at its widest point in the distal esophagus between the lower esophageal sphincter and 5 cm above. RESULTS: Seventy-four patients were treated in our center, and 5-year follow-up data were available in 55 patients (32 patients [58%] randomized to POEM, 23 [42%] PD). In the group initially treated with POEM, the incidence of BOM increased from 11.5% (4/38) at 3 months, to 21.1% (8/38) at 1 year, 27.8% (10/36) at 2 years, and 31.3% (10/32) at 5 years. None of the patients treated with PD alone developed a BOM. Patients who developed a BOM had a higher total Eckardt score and Eckardt regurgitation component compared with patients who underwent POEM without BOM development (3 [2.75-3.25] vs 2 [1.75-3], P = 0.032, and 1 [0.75-1] vs 0 [0-1], P = 0.041). POEM patients with a BOM more often report reflux symptoms (85% [11/13] vs 46% [2/16], P = 0.023) and had a higher acid exposure time (24.5% [8-47] vs 6% [1.2-18.7], P = 0.027). DISCUSSION: Thirty percent of the patients treated with POEM develop a BOM, which is associated with a higher acid exposure, more reflux symptoms, and symptoms of regurgitation.

Comparison of lumen-apposing metal stents versus endoscopic balloon dilation for the management of benign colorectal anastomotic strictures.

BACKGROUND AND AIMS: Limited data exist evaluating lumen-apposing metal stents (LAMSs) with endoscopic balloon dilation (EBD) for the treatment of benign colorectal anastomotic strictures (BCASs). This study compares outcomes of both interventions. METHODS: Patients with left-sided BCAS treated with LAMSs versus EBD were identified retrospectively. The primary outcome was a composite of crossover to another intervention to achieve clinical success or recurrence requiring reintervention. RESULTS: Twenty-nine patients (11 LAMS and 18 EBD) were identified with longer follow-up in the EBD group (734 vs 142 days; P = .003). No significant differences were found in the composite outcome, technical success, clinical success, or components of composite outcome. With LAMS, there was a nonsignificant trend toward fewer procedures (2.4 vs 3.3; P = .06) and adverse events (0% vs 16.7%; P = .26). CONCLUSIONS: LAMS appears to be as effective as EBD for the treatment of BCAS but may require fewer procedures and may be safer than EBD.

Administration of oral prednisolone to prevent esophageal stricture after balloon-type radiofrequency ablation for ultralong-segment esophageal neoplasia.

BACKGROUND AND AIMS: Endoscopic radiofrequency ablation (RFA) has shown good efficacy and safety in eradicating flat-type early esophageal squamous cell neoplasia (ESCN). However, post-RFA stricture is still a major concern, especially when treating ultralong-segment ESCNs. The aim of this study was to investigate the efficacy and safety of oral prednisolone to prevent post-RFA stricture. METHODS: We prospectively enrolled 48 patients treated with balloon-type RFA who had Lugol-unstained or mosaic-like flat-type ESCNs with an expected treatment area of >10 cm. Oral prednisolone was started at a dose of 30 mg/day on the third day after RFA and continued for 4 weeks. The results were compared with an historical control group of 25 patients who received RFA without oral steroids. The primary endpoint was the frequency of post-RFA stricture. Secondary endpoints were the number of balloon dilation sessions and adverse event rate. RESULTS: No significant differences were found in the worst pathology grade at baseline and length of unstained lesions between the 2 groups. The complete response rates after 1 session of RFA were 73% and 72%, respectively. Compared with the control group, the oral prednisolone group had a significantly lower stricture rate (4% [2/48 patients] vs 44% [11/25 patients]; P < .0001) and a lower number of balloon dilation sessions (median, 0 [range, 0-4] vs 6 [range, 0-10]). Two cases of asymptomatic candida esophagitis occurred in the study group, but no severe adverse effects. CONCLUSIONS: Oral prednisolone may offer a useful and safe preventive option for post-RFA stricture in ultralong ESCNs. (Clinical trial registration number: NCT05768282.).

Risk and protective factors for secondary procedures after endoscopic dilatation of primary obstructive megaureters.

PURPOSE: High-pressure balloon dilatation (HPBD) of the ureterovesical junction with double-J stenting is a minimally invasive alternative to ureteral reimplantation or cutaneous ureterostomy for first-line surgical treatment of primary obstructive megaureter (POM). The aim of our study was to identify the risk factors associated with the need for secondary procedures due to HPBD failure. METHODS: Prospective data were collected from patients who underwent HPBD for POM between 2007 and 2021 at a single institution. The collected data included patient demographics, diagnostic modalities, surgical details, results, and follow-up. Multivariate logistic regression analysis was performed. RESULTS: Fifty-five ureters underwent HPBD for POM in 50 children, with a median age of 6.4 months (IQR: 4.5-13.8). Nineteen patients (37.25%) underwent secondary ureteric reimplantation, with a median of 9.8 months after primary HBPD (95% CI 6.2-9.9). The median follow-up was 29.4 months (IQR: 17.4-71). Independent risk factors for redo-surgery in a multivariate logistic regression model were: progressive ureterohydronephrosis (OR = 7.8; 95% CI 0.77-78.6) and early removal of the double-J stent. A risk reduction of 7% (95% CI 2.2%-11.4%) was observed per extra-day of catheter maintenance. The optimal cut-off point is 55 days, ROC curve area: 0.77 (95% CI 0.62-0.92). Gender, distal ureteral diameter, pelvis diameter, dilatation balloon diameter and preoperative differential renal function did not affect the need for reimplantation. CONCLUSIONS: The use of a double-J stent for at least 55 days seems to avoid the need for a secondary procedure. Therefore, we recommend removing the double-J catheter at least 2 months after the HBPD.

Intensive triamcinolone acetonide injection regimen can highly prevent stricture after extensive esophageal endoscopic submucosal dissection.

BACKGROUND: This study aimed to investigate the utility of intensive triamcinolone acetonide (TA) injections after extensive esophageal endoscopic submucosal dissection (ESD). METHODS: This retrospective study included 27 lesions in 27 consecutive patients who underwent ESD (ulcers encompassing ≥3/4 of the esophageal circumference) and received TA injections without oral steroid administration. Groups A and B included patients undergoing ESD with and without complete circumferential resection, respectively. All patients received TA injections (100 mg/session) immediately after ESD. In Group A, weekly based TA injections were performed until near-complete ulcer epithelialization. In Group B, patients did not receive additional injections or received weekly or biweekly TA injections. The primary outcome was stricture rate, and the secondary outcomes were the proportion of patients requiring endoscopic balloon dilation (EBD) and the number of TA injections. RESULTS: Group A included 7 lesions, and Group B included 20 lesions. The median (range) tumor lengths were 40 (30-90) and 45 (30-110) mm in Groups A and B, respectively. In Group A, the median circumferential resection diameter was 40 (20-80) mm. The stricture rate and the proportion of patients requiring EBD were 0 (0%) in Group A and 1 (5.0%) in Group B. The number of TA injection sessions was significantly higher in Group A than in Group B (8 [5-25] vs 1.5 [1-3]; p < 0.001). CONCLUSIONS: Intensive weekly or biweekly based TA injections might aid in preventing post-ESD stricture and the need for EBD in patients undergoing extensive resection involving the entire esophageal circumference.

Clinical outcomes of drug-coated balloons dilatation for benign esophageal stricture.

BACKGROUND: Drug-coated balloons (DCBs) angioplasty is safe and effective for coronary artery disease. However, DCBs dilatation for the treatment of benign esophageal strictures is rarely reported. PURPOSE: We aimed to report the clinical outcomes of DCBs dilatation for patients with benign esophageal strictures. METHODS: From May 2020 to August 2023, 18 patients underwent DCBs dilatation for benign esophageal strictures. Baseline demographics were recorded and evaluated, including gender, age, comorbidities, stricture diameter and length, dilatation session, complications. RESULTS: A total of 24 dilatation sessions of DCBs were performed, with a mean of 1.3 ± 0.6 sessions per patients (range 1.0-5.0). Dysphagia score decreased significantly after DCBs dilatation (2.6 ± 1.1 vs. 0.9 ± 1.3, p = 0.0002). Both stricture diameter and stricture index decreased significantly after DCBs dilatation (p < 0.0001). No procedure-related death, massive bleeding or esophageal perforation was observed during or after DCBs dilatation. Minor complications were found in only 3 patients (16.7%). All 18 patients were successfully followed up for a median period of 12.0 months. By the end of follow up, 10 patients showed no dysphagia, 6 patients showed mild dysphagia and 2 patients showed no improvement in dysphagia. The clinical success rate of DCBs dilatation is 88.9%. CONCLUSION: DCBs dilatation may be a safe, effective and feasible treatment for benign esophageal strictures, and can be utilized as an alternative option after standard dilatation has failed. Prospective studies with large samples are needed to further validate its clinical efficacy.

Experiences of vaginal lengthening treatment and sexual well-being in women with Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome: An interview study.

OBJECTIVE: To explore how women with Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome experience dilation or surgical vaginal lengthening treatment, and their current sexual well-being. DESIGN: A qualitative interview study. SETTING: Denmark. POPULATION: Women aged ≥25 years diagnosed with MRKH syndrome. METHODS: Semi-structured video interviews were conducted with 18 women. Interviews lasted a median of 92 min and were digitally recorded, transcribed and anonymised. Data were analysed using thematic analysis. MAIN OUTCOME MEASURES: A qualitative analysis of women's experiences. RESULTS: The analysis identified three themes. Firstly, Experiences with dilation treatment revealed dilation as an awkward routine, especially for adolescents living with parents and yet to sexually debut. While some experienced successful vaginal lengthening, others faced treatment failure leading to frustration and self-blame. Secondly, Experiences with neovaginal surgery described the procedure as extremely painful but resulting in a 'normal size' vagina. Some women felt that the procedure had negatively impacted their self-confidence, and all underscored the importance of maturity before opting for surgery. Lastly, Current sex life and sexual well-being indicated a well-functioning sex life for many women, but with reported low sexual confidence and genital self-image due to the perceived 'deviance' of their genitalia. CONCLUSIONS: For women with MRKH syndrome, vaginal lengthening treatment, whether through dilation or surgery, may result in a 'normal size' vagina. However, according to the women's experiences, vaginal lengthening treatment does not adequately foster positive sexual esteem and genital self-image.

Patient reported outcomes of intermittent self-dilatation after direct vision internal urethrotomy.

PURPOSE: Long-term results on quality of life (QoL) as well as clinical outcomes of intermittent self-dilatation (ISD) of the urethra after direct visual internal urethrotomy (DVIU) are scarce. The aim of this study was to prospectively evaluate patient reported outcomes (PROs) on voiding symptoms and QoL in a large cohort of urethral stricture patients performing ISD. METHODS: We identified a total of 121 patients who performed ISD following DVIU between 2008 and 2013. Baseline assessment was conducted for each patient before ISD was started. Follow-up visits were scheduled in 6-month intervals. Each assessment included the following questionnaires: International prostate symptom score (IPSS), IPSS quality of life index (IPSS-QoL), patient global impression of severity (PGI-S), and patient global impression of improvement (PGI-I). Additional parameters were maximum urinary flow rate (Qmax ), postvoid residual urine, rate of complications, and stricture recurrence. Linear mixed models were used to examine the change over the course of the follow-up visits to the baseline. RESULTS: The median age of the patients was 58 years (interquartile range [IQR]: 43-70). The median follow-up was 17 months (IQR: 7-30). Mean change from baseline IPSS was -6.1, -5.9, -4.2, and -4.8 points at 6, 24, 36, and 48 months. Mean change from baseline IPSS-QoL was -1.3, -1.4, -1.6, and -1.8 points, respectively. Mean PGI-I was 1.7 points at 6, 1.9 points at 24, 1.9 points at 36, and 2.2 points at 48 months after ISD initiation. Mean change of Qmax ranged from 1.7 at 6 to 2.2 mL/s at 48 months. The median complication rate was 3.3% per 6-month ISD interval. Overall, 11 patients developed stricture recurrence (9%). CONCLUSION: ISD after DVIU had no negative impact on patients' QoL (IPSS-QoL, PGI-I, PGI-S). Urodynamic parameters remained stable for up to 48 months with low complications and an acceptable stricture recurrence rate.

Comparing Simulation Training of Bronchoscopy-Guided Percutaneous Dilatational Tracheostomy Using Conventional Versus 3D Printed Simulators (TRAC-Sim Study).

Background: Individual implementation rate of bronchoscopy-guided percutaneous dilatational tracheostomy (PDT) varies among intensivists. Simulation training (ST) can increase the safety of medical procedures by reducing stress levels of the performing team. The aim of this study was to evaluate the benefit of ST in PDT regarding procedural time, quality of performance, and percepted feelings of safety of the proceduralist and to compare conventional simulators (CSIM) with simulators generated from 3D printers (3DSIM). Methods: We conducted a prospective, single-center, randomized, blinded cross-over study comparing the benefit of CSIM versus 3DSIM for ST of PDT. Participants underwent a standardized theoretical training and were randomized to ST with CSIM (group A) or 3DSIM (group B). After ST, participants' performance was assessed by two blinded examiners on a porcine trachea regarding time required for successful completion of PDT and correct performance (assessed by a performance score). Percepted feelings of safety were assessed before and after ST. This was followed by a second training and second assessment of the same aspects with crossed groups. Results: 44 participants were included: 24 initially trained with CSIM (group A) and 20 with 3DSIM (group B). Correctness of the PDT performance increased significantly in group B (p < .01) and not significantly in group A (p = .14). Mean procedural time required for performing a PDT after their second ST compared to the first assessment (p < .01) was lower with no difference between group A and group B and irrespective of the participants' previous experience regarding PDT, age, and sex. Moreover, percepted feelings of safety increased after the first ST in both groups (p < .001). Conclusions: ST can improve procedural skills, procedural time, and percepted feelings of safety of the proceduralist in simulated PDT.

Endoscopic incisional therapy for benign anastomotic strictures after esophagectomy or gastrectomy: a systematic review and meta-analysis.

BACKGROUND: Studies have evaluated the efficacy of endoscopic incisional therapy (EIT) for benign anastomotic strictures. We performed a systematic review and meta-analysis to evaluate stricture recurrence after EIT following esophagectomy or gastrectomy. METHODS: A systematic search of databases was performed up to April 2nd, 2023, after selection of key search terms with the research team. Inclusion criteria included human participants undergoing EIT for a benign anastomotic stricture after esophagectomy or gastrectomy, age ≥ 18, and n ≥ 5. Our primary outcome was the incidence of stricture recurrence among patients treated with EIT compared to dilation. Our secondary outcome was the stricture-free duration after EIT and rate of adverse events. Meta-analysis was performed with RevMan 5.4.1 using a Mantel-Haenszel random-effects model. Publication bias was evaluated with funnel plots and the Egger test. RESULTS: A total of 2550 unique preliminary studies underwent screening of abstracts and titles. This led to 33 studies which underwent full-text review and five studies met the inclusion criteria. Meta-analysis revealed reduced odds of overall stricture recurrence (OR 0.35, 95% CI 0.13-0.92, p = 0.03; I2 = 71%) and reduced odds of stricture recurrence among naïve strictures (OR 0.32, 95% CI 0.17-0.59, p = 0.0003; I2 = 0%) for patients undergoing EIT compared to dilation. There was no significant difference in the odds of stricture recurrence among recurrent strictures (OR 0.63, 95% CI 0.12-3.28, p = 0.58; I2 = 81%). Meta-analysis revealed a significant increase in the recurrence-free duration (MD 42.76, 95% CI 12.41-73.11, p = 0.006) among patients undergoing EIT compared to dilation. CONCLUSION: Current data suggest EIT is associated with reduced odds of stricture recurrence among naïve anastomotic strictures. Large, prospective studies are needed to characterize the safety profile of EIT, address publication bias, and to explore multimodal therapies for refractory strictures.

Risk factors for the failure of endoscopic balloon dilation to manage anastomotic stricture from colorectal surgery: retrospective cohort study.

BACKGROUND: An anastomotic stricture after colorectal surgery is principally managed by endoscopic balloon dilation (EBD). Although this intervention is effective, however, subsequent procedures or surgical interventions are often required. This study aimed to assess the long-term outcomes of EBD for anastomotic stricture arising from colorectal cancer surgery. MATERIALS AND METHODS: We analyzed 173 patients who received curative surgery for colorectal cancer at our hospital between January 2000 and December 2022 and had undergone EBD to manage anastomotic stricture. The medical records of these cases were retrospectively reviewed to assess the outcomes and risk factors for restenosis and permanent stoma. RESULTS: Of the 173 study patients, 41 (23.7%) presented with restenosis with a median time to recurrence of 49 [37-150] days. The restenosis group was significantly younger (55.6 years versus 60.8 years), with a more prominent rectal location (80.5% versus 57.6%), a higher incidence of hand-sewn anastomosis (24.4% versus 5.3%), and a higher percentage of neoadjuvant radiotherapy (34.1% versus 5.3%, P < 0.001). Multivariable analysis indicated neoadjuvant radiotherapy (adjusted HR 2.48; 95% CI 1.03-5.95) and cerebral vascular disease (adjusted HR 6.97; 95% CI 2.15-22.54) as independent prognostic factors for restenosis. Fourteen patients (8.1%) required a permanent stoma due to treatment failure. All cases needing a permanent stoma were male (14 patients, 100%, P = 0.007) and this group had a higher rate of neoadjuvant radiotherapy, adjuvant chemotherapy, and hand-sewn anastomosis. CONCLUSION: Patients receiving neoadjuvant radiotherapy are most prone to restenosis after an EBD intervention to manage an anastomotic stricture. Neoadjuvant radiotherapy is also a strong risk factor for requiring a permanent stomas due to treatment failure.

Esophageal Self-Dilation in Benign Refractory Esophageal Strictures: Outcomes from a Randomized Controlled Trial and a Prospective Observational Study.

BACKGROUND: Patients with benign esophageal strictures may not maintain a response to endoscopic dilation, stenting, incisional or injectional therapies. For patients with these refractory esophageal strictures, esophageal self-dilation therapy (ESDT), performed to maintain luminal patency, may provide persistent symptomatic benefit while reducing patients' reliance on healthcare services and the risk associated with repeated endoscopic procedures. AIMS: The aim of this study was to evaluate the efficacy and safety of EDST in a randomized controlled trial and prospective observational study. METHODS: Twenty-five patients with refractory benign esophageal strictures were recruited at two esophageal clinics between November 2018 and June 2021. Twelve patients participated in the randomized trial and 13 in the prospective observational study. The number of endoscopic dilations, impact of therapy on dysphagia, adverse events, and complications were recorded. RESULTS: In the randomized study, 50% of patients performing ESDT and 100% of controls required endoscopic dilation during follow-up (P = 0.02). In the observational study, the median (IQR) number of endoscopic dilations fell from 7 [7-10] in the 6 months prior to commencing ESDT to 1 [0-2] in the 6 months after (P < 0.0001). Most patients (22/25) were able to learn self-dilation. Few serious adverse events were noted. Dysphagia severity remained unchanged or improved. CONCLUSIONS: ESDT appears to be a safe effective therapy for benign esophageal strictures refractory to endoscopic treatment. CLINICAL TRIAL NUMBER: NCT03738566.

Complications after Heller myotomy in children: a national multicenter study on the impact of prior endoscopic dilatation and identification of risk factors.

BACKGROUND: Although esophageal achalasia has been historically treated by Heller myotomy, endoscopic esophageal dilatations are nowadays often the first-line treatment in children. The aim was to assess whether performing an endoscopic dilatation before a Heller myotomy is associated with higher risks of esophageal perforation in children. METHODS: A retrospective multicentric study was performed, including children that underwent a Heller myotomy (2000-2022, 10 centers). Two groups were compared based on the history of previous dilatation before myotomy. Outcomes esophageal perforation (intra-operative or secondary) and post-operative complications requiring surgery (Clavien-Dindo III). Statistics Comparisons using contingency tables or Kruskal-Wallis when appropriate. Statistical significance: p-value < 0.05. RESULTS: A Heller myotomy was performed in 77 children (median age: 11.8 years), with prior endoscopic dilatation in 53% (n = 41). A laparoscopic approach was used in 90%, with associated fundoplication in 95%. Esophageal perforation occurred in 19% of children (n = 15), including 12 patients with intra-operative mucosal tear and 3 with post-operative complications related to an unnoticed esophageal perforation. Previous endoscopic dilatation did not increase the risk of esophageal perforation (22% vs 17%, OR: 1.4, 95%CI: 0.43-4.69). Post-operative complications occurred in 8% (n = 6), with similar rates regardless of prior endoscopic dilatation. Intra-operative mucosal tear was the only risk factor for post-operative complications, increasing the risk of complications from 5 to 25% (OR: 6.89, 95%CI: 1.38-31.87). CONCLUSIONS: Prior endoscopic dilatations did not increase the risk of esophageal perforation or postoperative complications of Heller myotomy in this cohort of children with achalasia. Mucosal tear was identified as a risk factor for post-operative complications.

Antegrade balloon dilatation of the duodenal papilla during laparoscopic cholecystectomy versus endoscopic retrograde cholangiography in patients with acute choledocholithiasis: a case control matched study.

INTRODUCTION: In acute obstructive common bile duct (CBD) stones endoscopic retrograde cholangiography for CBD stone removal before cholecystectomy (ChE) ('ERC-first') is the gold standard of treatment. Intraoperative antegrade balloon dilatation of the duodenal papilla during ChE with flushing of CBD stones to the duodenum ('ABD-during-ChE') may be an alternative 'one-stop-shop' treatment option. However, a comparison of outcomes of the 'ABD-during-ChE' technique and the'ERC-first' approach has never been performed. METHODS: Retrospective case control matched study of patients suffering from obstructive CBD stones (< 8 mm) without severe pancreatitis or cholangitis that underwent the traditional 'ERC-first' approach versus the 'ABD-during-ChE' technique. Primary endpoint was the overall Comprehensive Complication Index (CCI®) from diagnosis to complete CBD stone removal and performed ChE. RESULTS: A total of 70 patients were included (35 patients each in the 'ERC first'- and 'ABD-during-ChE'-group). There were no statistical significant differences in terms of demographics and disease specific characteristics between the two study groups. However, there was a not significant difference towards an increased overall CCI® in the 'ERC-first' group versus the 'ABD-during-ChE' group (14.4 ± 15.4 versus 9.8 ± 11.1, p = 0.225). Of note, six major complications (Clavien-Dindo classification ≥ IIIa) occurred in the 'ERC-first' group versus two in the 'ABD-during-ChE' group (17% versus 6%, p = 0.136). In addition, significantly more interventions and a longer overall time from diagnosis to complete clearance of bile ducts and performed ChE was found, when comparing the 'ERC-first' group and the 'ABD-during-ChE' group (3.7 ± 0.8 versus 1.1 ± 0.4, p < 0.001; 160.5 ± 228.6 days versus 12.0 ± 18.0 days, p < 0.001). CONCLUSION: In patients suffering from acute obstructive CBD stones smaller than 8 mm, compared to the 'ERC-first' approach, the 'ABD-during-ChE' technique resulted in significantly less interventions and reduced overall treatment time from diagnosis to complete clearance of bile ducts and performed ChE. This comes together with a strong trend of less intervention related complications in the 'ABD-during-ChE' group.

Safety and Efficacy of Covered Self-Expandable Metallic Stent for Choledochojejunal Anastomotic Stricture: A Multi-Center Retrospective Cohort Study.

BACKGROUND: Benign choledochojejunal anastomotic stricture (CJS) is a complication of pancreaticoduodenectomy and choledochojejunostomy. Typically managed with endoscopic balloon dilatation, CJS has a high recurrence rate. Covered metallic stent (CMS) placement is a potential alternative; however, a comprehensive evaluation is lacking. OBJECTIVES: The aim of this study was to evaluate the treatment outcomes of CMS placement in patients with CJS. METHODS: We retrospectively analyzed patients who underwent balloon dilation via endoscopic retrograde cholangiopancreatography using a double-balloon endoscope for CJS between October 2010 and October 2023. The study outcomes included technical and clinical success rates, adverse event rates, choledochojejunal anastomotic stricture recurrence rates, and time to recurrence for balloon dilation and CMS treatment for CJS. RESULTS: There were 43 patients, 55 procedures (40 balloon dilation and 15 CMS placement). The technical and clinical success rates were 100% for both treatments. Recurrence of CJS was observed in 35% (14/40) of the patients in the balloon dilation group. The recurrence rate was significantly higher in the balloon dilation group than in the CMS group (35% vs. 0%, p = 0.006). The time to CJS recurrence was significantly shorter in the balloon dilation group than in the covered metallic stent group (NR vs. NR, p = 0.03). CONCLUSION: Placement of CMS for treating patients with CJS was demonstrated to be an effective and safe method with a lower recurrence rate than balloon dilation.

Clinical outcomes of serial endoscopic balloon dilation for duodenal Crohn's disease-associated strictures.

BACKGROUND: Endoscopic balloon dilation (EBD) is a safe and effective treatment for Crohn's disease (CD)-associated strictures. However, serial EBDs have rarely been reported. This study aimed to evaluate the efficacy and safety of serial EBDs for treating CD-associated duodenal strictures compared with intermittent EBDs. METHODS: Patients with CD-associated duodenal strictures who underwent EBD were recruited. The clinical data, stricture characteristics, number of EBDs, dilation diameter, complications, surgical interventions, and follow-up periods were recorded. Patients were divided into a serial dilation group and an intermittent dilation group to analyze the differences in safety and efficacy. RESULTS: Forty-five patients with duodenal CD-associated strictures underwent a total of 139 dilations. A total of 23 patients in the serial dilation group underwent 72 dilations, for a median of 3 (range 3 ~ 4) dilations per patient, and 22 patients in the intermittent dilation group underwent 67 dilations, for a median of 3 (range 1 ~ 6) dilations per patient. Technical success was achieved in 97.84% (136/139) of the patients. During the follow-up period, three patients in the intermittent dilation group underwent surgery, and the total clinical efficacy was 93.33% (42/45). No difference in safety or short-term efficacy was noted between the two groups, but serial EBDs exhibited significantly greater clinical efficacy between 6 months and 2 years. No significant difference in recurrence-free survival was observed, but the median longest recurrence-free survival and recurrence-free survival after the last EBD in the serial dilation group were 693 days (range 298 ~ 1381) and 815 days (range 502 ~ 1235), respectively, which were significantly longer than the 415 days (range 35 ~ 1493) and 291 days (range 34 ~ 1493) in the intermittent dilation group (p = 0.013 and p = 0.000, respectively). At the last follow-up, the mean diameter of the duodenal lumen was 1.17 ± 0.07 cm in the serial dilation group, which was greater than the 1.11 ± 0.10 cm in the intermittent dilation group (p = 0.018). We also found that the Simple Endoscopic Score for Crohn's Disease was associated with an increased risk of surgical intervention (HR 2.377, 95% CI 1.125-5.020; p = 0.023) and recurrence at 6 months after the last EBD (HR 0.698, 95% CI 0.511-0.953; p = 0.024), as assessed by univariate analysis. CONCLUSIONS: Compared to the intermittent EBDs, serial EBDs for duodenal CD-associated strictures exhibit greater clinical efficacy within two years and could delay stricture recurrence. We suggest that serial EBDs can be a novel option for endoscopic treatment of duodenal CD-associated strictures.

Risk factors for and treatment of anastomotic strictures after Ivor Lewis esophagectomy.

INTRODUCTION: Anastomotic strictures following esophagectomy occur frequently and impact on nutrition and quality of life. Although strictures are often attributed to ischemia and anastomotic leaks, the role of anastomosis size and pyloroplasty is not well evaluated. Our study aims to assess the rate of and risk factors for anastomotic stricture following esophagectomy, and the impact of treatment with regular endoscopic balloon dilatations. METHODS: Consecutive patients (n = 207) undergoing Ivor Lewis esophagectomy performed by two surgeons at our institution were included. Data on patient demographics, surgical outcomes and anastomotic strictures were recorded. Relationship of anastomotic strictures with circular stapler size, pyloroplasty and anastomotic leak was analyzed. Treatment of strictures with endoscopic balloon dilatation was reviewed and percentage weight loss at 1 year was evaluated. RESULTS: Anastomotic strictures occurred in 17.4% of patients. Patient demographics between those with and without stricture were similar. Stricture rate was similar in patients with or without pyloroplasty (13.9% vs 21.7%, respectively, p = 0.14) and in those with or without an anastomotic leak (25.0% vs 16.6%, respectively, p = 0.345). Stricture risk increased with smaller sized stapler (25 mm = 33.3%, 28 mm = 15.3%, 31 mm = 4.8%; p = 0.027). The median number of dilatations required to fully treat strictures was 2 (IQR: 1-3). The median length of time from surgery to first dilatation was 2.9 months (IQR: 2.0-4.7) and to last dilatation was 6.1 months (IQR: 4.8-10.0). Median maximum dilatation diameter was 20 mm (IQR: 18.0-20.0). There were no complications from dilatations. Percentage weight loss at 1 year in patients with strictures was similar to those without strictures (8.7% vs 11.1%, respectively, p = 0.090). CONCLUSIONS: Post-esophagectomy anastomotic strictures are common and not necessarily related to anastomotic leaks or absence of pyloroplasty. Smaller anastomosis size was strongly linked with stricture formation. A driven approach with regular endoscopic balloon dilation is safe and effective in treating these strictures with no excess weight loss at 1 year once treated.

Clinical outcomes of endoscopic balloon dilation for dysphagia after anti-gastroesophageal reflux surgery.

BACKGROUND: Dysphagia is a potential complication following anti-gastroesophageal reflux surgery (ARS), with challenging management. Endoscopic balloon dilation is recommended for patients with significant dysphagia from tight wraps or strictures. We aim to evaluate factors associated with the need for post-ARS dilation and the outcomes of balloon dilation. Additionally, we assessed the predictors of sustained clinical failure after dilation. METHODS: A retrospective analysis was conducted on patients who underwent robotic or laparoscopic ARS between January 2012 and April 2023. Patients were divided based on whether they received balloon dilation using a through-the-scope wire-guided dilator. Excluded were those with pre-existing achalasia, other dilation devices, or inadequate follow-up. RESULTS: Of 1002 patients, 69 underwent 94 postoperative dilations, and the remainder were controls. The dilation cohort was older (63.78 vs. 56.14 years, P = 0.032) and had more magnetic sphincter augmentations (MSA) (P = 0.004), a prior history of ARS (P = 0.039), and a higher rate of laparoscopic surgery (P = 0.009) compared to controls. Of all dilations, 54 (57.5%) patients reported immediate dysphagia improvement, and 39 (41.5%) had sustained improvement. Sixteen (23.2%) patients required reoperation, primarily for hiatal hernia recurrence or slipped wrap. Multivariable logistic regression showed that MSA (OR 0.04, 95% CI 0.01-0.46, P = 0.031) and requiring multiple dilations (OR 0.16, CI 0.03-0.68) predicted sustained dilation failure. CONCLUSIONS: Factors including older age, history of prior ARS, and MSA are correlated with higher post-ARS dilation rates. Although dilation improves symptoms in approximately half of patients initially, one-fourth may eventually require reoperation, mostly due to a slipped wrap or hernia recurrence. Thus, in cases of persistent dysphagia, consideration for surgical failure is important, and further imaging and workup are warranted. Patients who undergo MSA and those who have more than one dilation are more likely to experience dilation failure.

Effect of an Intrapartum Pelvic Dilator Device on Levator Ani Muscle Avulsion During Primiparous Vaginal Delivery: A Pilot Randomized Controlled Trial.

INTRODUCTION AND HYPOTHESIS: The objective was to evaluate the safety and effectiveness of an intrapartum electromechanical pelvic floor dilator designed to reduce the risk of levator ani muscle (LAM) avulsion during vaginal delivery. METHODS: A multicenter, randomized controlled trial enrolled nulliparous participants planning vaginal delivery. During the first stage of labor, participants were randomized to receive the intravaginal device or standard-of-care labor management. The primary effectiveness endpoint was the presence of full LAM avulsion on transperineal pelvic-floor ultrasound at 3 months. Three urogynecologists performed blinded interpretation of ultrasound images. The primary safety endpoint was adverse events (AEs) through 3 months. RESULTS: A total of 214 women were randomized to Device (n = 113) or Control (n = 101) arms. Of 113 Device assignees, 82 had a device placed, of whom 68 delivered vaginally. Of 101 Control participants, 85 delivered vaginally. At 3 months, 110 participants, 46 Device subjects who received full device treatment, and 64 Controls underwent ultrasound for the per-protocol analysis. No full LAM avulsions (0.0%) occurred in the Device group versus 7 out of 64 (10.9%) in the Control group (p = 0.040; two-tailed Fisher's test). A single maternal serious AE (laceration) was device related; no neonate serious AEs were device related. CONCLUSIONS: The pelvic floor dilator device significantly reduced the incidence of complete LAM avulsion in nulliparous individuals undergoing first vaginal childbirth. The dilator demonstrated an acceptable safety profile and was well received by recipients. Use of the intrapartum electromechanical pelvic floor dilator in laboring nulliparous individuals may reduce the rate of LAM avulsion, an injury associated with serious sequelae including pelvic organ prolapse.