Safety and feasibility of same day discharge after per oral endoscopic pyloromyotomy in refractory gastroparesis: a pilot study.

BACKGROUND: Gastroparesis is a debilitating medical condition with limited treatment options. Gastric per-oral pyloromyotomy (G-POEM) has emerged as a promising treatment option with remarkable short-term clinical success shown in multiple studies. While the post-procedure protocol is not standardized across many centers, the majority of the centers observes these patients in the hospital after the procedure for monitoring. In this single-center prospective study, we evaluated the safety and feasibility of same day discharge after the G-POEM procedure. METHODS: All the patients with refractory gastroparesis undergoing G-POEM from October 2019 to March 2020 were enrolled. A total of 25 patients were enrolled in the procedure. Based on the pre-defined criteria, patients were either discharged on the same day after the procedure or admitted to the hospital for further observation. The patient and procedure-related data were extracted from the chart review. Univariate analysis was performed (chi-squared test) on categorical variables after organizing categorical variables as numeric counts or percentages. The student t test was performed on continuous variables after reporting as mean and standard deviation. For analysis with a smaller sample size, Fisher exact and Mann-Whitney tests were used. RESULTS: A total of 25 patients were enrolled. The technical success of G-POEM was 100% and clinical success was 80% (20/25) at 1-month follow-up. Of the 25 patients, 9 patients (36%) were discharged on the same day according to the procedure from the recovery unit. Of the remaining 16 patients who were admitted to the hospital post-procedure, 10 (40%) were admitted due to procedure-related causes while other admissions were either pre-planned or due to social reasons. The average Charlson comorbidity index was lower in the same day discharge group ( P   <  0.05). The number of patients requiring double myotomy was higher in the same day discharge group ( P  < 0.05). The overall complication rate of G-POEM in the study cohort was 12% (3/25) with all complications being mild without any severe adverse events. CONCLUSION: G-POEM is a safe and effective method of treatment for refractory GP with higher clinical success in short-term follow-up. The same day discharge after G-POEM is safe and feasible in >50% of patients with close periprocedural monitoring.

Quantification of Interstitial Cells of Cajal in the Gastric Muscle of Patients with Gastroparesis at Per-Oral Endoscopic Pyloromyotomy: A Novel Approach for Future Research in Pathogenesis of Gastroparesis.

BACKGROUND: The role of Interstitial Cells of Cajal (ICC) in the pathogenesis of gastroparesis has been suggested by previous studies due to their involvement in the transmission of neuronal signaling to the smooth muscles of the GI tract. However, studies have been limited by the inability to obtain a gastric muscle sample, since routine endoscopy can only biopsy the mucosa. We present a new technique of muscle biopsy during per-oral endoscopic pyloromyotomy (GPOEM), a novel endoscopic procedure for treatment of gastroparesis. PATIENTS AND METHODS: All enrolled patients had diagnosed gastroparesis and had biopsies of the muscular layer at the antrum/pylorus during POEM. All GPOEM procedures took place from August 2019 to December 2019. Various demographic, disease-related, and procedure-related data were collected from chart review. ICC in the biopsy specimen was examined and quantitated. RESULTS: Through this method, we readily expose the gastric muscle of 21 patients through dissection of a gastric submucosal tunnel during GPOEM and provide reliable muscle sample for ICC quantification. Average number of ICC were higher in clinical responders (88 ICC ± 63 vs. 39 ICC ± 24, p = 0.02), defined as those who experienced significant improvement in nausea and vomiting symptoms after GPOEM. CONCLUSIONS: This study provides a reliable novel biopsy method for safely biopsy gastric muscle for quantitating the number of gastric ICC in patients with gastroparesis. The number of ICC may be related to the outcome of GPOEM therapy. However, further studies with larger number of patients are needed to confirm the results.

Simultaneous Examination of Eosinophil Infiltration in Esophageal Mucosa and Muscle in Patients with Achalasia: Direct Biopsy of the Esophageal Muscle at Per-oral Endoscopic Myotomy.

BACKGROUND: The relationship between eosinophilic esophagitis (EoE) and achalasia is not completely understood. There have been reports of eosinophilic infiltration of all esophageal layers in patients with achalasia. However, a routine endoscopic biopsy of the muscular layer is usually not feasible. We evaluate the safety and efficacy of muscle layer biopsy during per-oral endoscopic myotomy (POEM) as well as the prevalence of eosinophilic infiltration of the esophageal mucosa and muscular layer in patients with achalasia. PATIENTS AND METHODS: All enrolled patients had diagnosed achalasia and had simultaneous biopsies of the muscular layer at the middle esophagus and distal esophageal sphincter as well as the mucosal layer of the proximal and distal esophagus during POEM. All POEM procedures took place from August 2018 to December 2018 or September 2019 to November 2019. Various demographic, disease-related, and procedure-related data were collected from chart review. Eosinophilic infiltration in the biopsy specimen was examined. KEY RESULTS: Twenty consecutive patients (65% female, age range: 21-84) with a pre-procedure Eckardt score of >6 were enrolled during the study period, with the duration of their achalasia ranging from 1 to 32 years. Eighteen patients had clinical symptomatic improvement after POEM, as defined by an Eckardt score <3. Endoscopic examination did not reveal any signs of eosinophilic esophagitis. Pathologic examination of biopsies revealed eosinophilic infiltration in three of 20 patients (15%) in the distal esophageal mucosa (all <15 eosinophils/HPF) and none in the proximal esophageal mucosa. There was no eosinophilic infiltration in the distal esophageal sphincter and the middle esophageal muscle. No complication was noted due to muscle biopsy. CONCLUSIONS AND INFERENCES: Submucosal tunneling during POEM provides a safe access for direct esophageal muscle biopsy. This is the first report of the simultaneous biopsy of the esophageal mucosa and muscle in patients with achalasia. Contrary to all previously published studies, the association of esophageal eosinophilic infiltration and achalasia was not observed in this small sample study. Based on our findings, immune or autoimmune reaction rather than direct eosinophilic infiltration in the muscle is more likely the cause of achalasia.

Long-term Outcome of Per-oral Endoscopic Myotomy Performed in the Endoscopy Unit With Trainees.

INTRODUCTION: Per-oral endoscopic myotomy (POEM) has been widely adopted for the treatment of achalasia as it provides a precise, tailored myotomy in a minimally invasive endoscopic procedure. Several short-term studies and a few long-term studies have confirmed that POEM is a safe and effective treatment for achalasia. However, the long-term outcome of POEM performed by trainees is unknown. MATERIALS AND METHODS: We conducted a retrospective study of all patients who underwent POEM for achalasia at our tertiary care center during December 2012 and January 2019. All procedures performed with trainees were included. The primary outcome was the clinical response to POEM, defined as an Eckardt score of <3 after POEM. Trainees were trained in performing mucosotomy and submucosal dissection, creating a submucosal tunnel, identifying gastroesophageal junction, and performing myotomy and closure of mucosal incision in a step-by-step fashion. Trainees' performance was evaluated by the mentor based on several key points in each step. RESULTS: A total of 153 consecutive patients with a median age of 57±18 years were analyzed in this study. Of the total patients, 69 (45%) were male. The median length of follow-up after POEM was 32 months (range: 7 to 77 mo). A clinically significant response to POEM was achieved in 95% of patients at year 1, 84% at year 2, 80% at year 3, 79% at year 4, 78% at year 5, and 78% at year 6 and above. All trainees obtained competence within 6 cases for each step and could perform the procedure alone after 20 supervised cases. CONCLUSIONS: Overall, 78% of patients maintained positive clinical response at 6 years following POEM procedure. The recurrence rate of symptoms following POEM was 22% at a 6-year follow-up. This long-term outcome of POEM performed with trainees was comparable to those without trainees in other studies. To our knowledge, this is the longest follow-up and the largest number of patients after the POEM procedure performed with trainees.

Gastric peroral endoscopic pyloromyotomy versus gastric electrical stimulation in the treatment of refractory gastroparesis: a propensity score-matched analysis of long term outcomes.

BACKGROUND : Gastric peroral endoscopic pyloromyotomy (G-POEM) and gastric electrical stimulation (GES) have been reported as treatment options for refractory gastroparesis. In this study, we compared the long term clinical outcomes of G-POEM versus GES in the treatment of such patients. METHODS : We retrospectively evaluated 111 consecutive patients with refractory gastroparesis between January 2009 and August 2018. To overcome selection bias, we used propensity score matching (1:1) between G-POEM and GES treatment. The primary outcome was the duration of clinical response. RESULTS : After propensity score matching, 23 patients were included in each group. After a median follow-up of 27.7 months, G-POEM had a significantly better and longer clinical response than GES (hazard ratio [HR] for clinical recurrence 0.39, 95 % confidence interval [CI] 0.16 - 0.95; P = 0.04). The median duration of response was 25.4 months (95 %CI 8.7 - 42.0) in the GES group and was not reached in the G-POEM group. The Kaplan - Meier estimate of 24-month clinical response rate was 76.6 % with G-POEM vs. 53.7 % with GES. GES appeared to have little effect on idiopathic gastroparesis (HR for recurrence with G-POEM vs. GES 0.35, 95 %CI 0.13 - 0.95; P = 0.05). The incidence of adverse events was higher in the GES group (26.1 % vs. 4.3 %; P = 0.10). CONCLUSION : Among patients with refractory gastroparesis, clinical response was better and lasted longer with G-POEM than with GES. The positive outcomes with G-POEM are likely to derive from the superior clinical response in patients with idiopathic gastroparesis. Further studies are needed to confirm these findings.

Outcomes of a single-step endoscopic ultrasound-guided drainage of pancreatic-fluid collections using an electrocautery-enhanced coaxial lumen-apposing, self-expanding metal stent with and without fluoroscopy.

BACKGROUND: Fluoroscopy is often used during the endoscopic drainage of pancreatic-fluid collections (PFCs). An electrocautery-enhanced coaxial lumen-apposing, self-expanding metal stent (ELAMS) facilitates a single-step procedure and may avoid the need for fluoroscopy. This study compares the treatment outcomes using ELAMS with and without fluoroscopy. METHODS: Patients with PFCs who had cystogastrostomy from January 2014 to February 2017 were enrolled. Two groups were studied based on fluoroscopy use. Technical success was defined as uneventful insertion of ELAMS at time of procedure. Clinical success was defined as (i) clinical resolution of symptoms after the procedure and (ii) >75% reduction in cyst size on computed tomography 8 weeks after stent placement. Adverse events including bleeding, stent migration, and infection were recorded. RESULTS: A total of 21 patients (13 males) had PFCs drainage with ELAMS in the study period. The mean age was 51.6 ± 14.2 years. Thirteen patients had walled-off necrosis while eight had a pancreatic pseudocyst. The mean size of the PFCs was 11.3 ± 3.3 cm. Fluoroscopy was used in seven cases (33%) and was associated with a longer procedure time compared to non-fluoroscopy (43.1 ± 10.4 vs 33.3 ± 10.5 min, P = 0.025). This association was independent of the size, location, or type of PFCs. Fluoroscopy had no effect on the technical success rates. In fluoroless procedures, the clinical resolution was 91% as compared to 71% in fluoroscopy procedures (P = 0.52) and the radiologic resolution was 57% as compared to 71% in fluoroscopy procedures (P = 0. 65). Three cases of stent migration/displacement occurred in the fluoroless procedures. CONCLUSIONS: ELAMS may avoid the need for fluoroscopy during cystogastrostomy. Procedures without fluoroscopy were significantly shorter and fluoroscopy use had no impact on the technical or clinical success rates.

Functional lumen imaging probe in gastrointestinal motility diseases.

Dysfunction of gastrointestinal (GI) sphincters, including the lower esophageal sphincter (LES) at the esophagogastric junction (EGJ) and the pyloric sphincter, plays a vital role in GI motility disorders, such as achalasia, gastroesophageal reflux disease (GERD), gastroparesis, and fecal incontinence. Using multi-detector high-resolution impedance planimetry, the functional luminal imaging probe (FLIP) system measures simultaneous data on tissue distensibility and luminal geometry changes in the sphincter in a real-time manner. In this review we focus on the emerging data on FLIP, which can be used as an innovative diagnostic method during endoscopic or surgical procedures in GI motility disorders. Subsequent large, prospective, standardizing studies are needed to validate these findings before it can be put to routine clinical use.

Safety and efficacy of coaxial lumen-apposing metal stents in the management of refractory gastrointestinal luminal strictures: a multicenter study.

BACKGROUND AND AIMS: Benign gastrointestinal (GI) strictures are often refractory to standard endoscopic interventions. Fully covered coaxial lumen-apposing metal stents (LAMS) have emerged as a novel therapy for these strictures. The aim of this study was to evaluate the safety and efficacy of LAMS for refractory GI strictures. PATIENTS AND METHODS: A retrospective analysis was performed for patients who underwent LAMS placement for benign luminal strictures in three US centers between January 2014 and December 2016. The primary outcomes were technical success and initial clinical success of LAMS placement. Secondary outcomes were stent migration, rate of re-intervention, and adverse events. RESULTS: A total of 49 patients underwent 56 LAMS placement procedures. Previous treatment had failed in 39 patients (79.6 %), and anastomotic strictures were the indication in 77.6 % (38/49), with the most common site being gastrojejunal (34.7 % [17/49]). Technical success was achieved in all procedures and initial clinical success was achieved in 96.4 % of all procedures (54/56). Patient initial clinical success was 95.9 % (47/49). Stent migration occurred in 17.9 % of procedures, and was more likely to occur at sites in the lower GI tract ( P  = 0.02). The mean stent dwell time was 100.6 days, and the mean follow-up was 169.8 days. Minor adverse events, not requiring hospitalization, occurred in 33.9 % of procedures, including subsequent stricture progression (10.7 %). In cases where LAMS were removed, mean follow-up time was 102.2 days. The re-intervention rate was 75 % at 300 days follow-up after stent removal. Of the LAMS placed at anastomotic strictures, 36.4 % required re-intervention, with approximately two-thirds of these re-interventions requiring placement of a new stent or surgery. CONCLUSION: LAMS placement was successful for the management of refractory GI strictures, with good technical and initial clinical success rates. However, re-intervention rates after LAMS removal were high, and many strictures were not resolved by an extended period of stenting with these coaxial stents. LAMS placement offers additional therapeutic options and in selected cases might be considered a destination therapy for patients with recalcitrant benign strictures.

Concurrent myotomy and tunneling after establishment of a half tunnel instead of myotomy after establishment of a full tunnel: a more efficient method of peroral endoscopic myotomy.

BACKGROUND AND STUDY AIMS: Peroral endoscopic myotomy (POEM) is a time-consuming and challenging procedure. Traditionally, the myotomy is done after the submucosal tunnel has been completed. Starting the myotomy earlier, after submucosal tunneling is half completed (concurrent myotomy and tunneling), may be more efficient. This study aims to assess if the method of concurrent myotomy and tunneling may decrease the procedural time and be efficacious. PATIENTS AND METHODS: This is a retrospective case series of patients who underwent modified POEM (concurrent myotomy and tunneling) or traditional POEM at a tertiary care medical center. Modified POEM or traditional POEM was performed at the discretion of the endoscopist in patients presenting with achalasia. The total procedural duration, myotomy duration, myotomy length, and time per unit length of myotomy were recorded for both modified and traditional POEM. RESULTS: Modified POEM was performed in 6 patients whose mean age (± standard deviation [SD]) was 58 ±â€Š13.3 years. Of these, 5 patients had type II achalasia and 1 patient had esophageal dysmotility. The mean Eckardt score (±â€ŠSD) before the procedure was 8.8 ±â€Š1.3. The modified technique was performed in 47 ±â€Š8 minutes, with 6 ±â€Š1 minutes required per centimeter of myotomy and 3 ±â€Š1 minutes required per centimeter of submucosal space. The Eckardt score was 3 ±â€Š1.1 at 1 month and 3 ±â€Š2.5 at 3 months. The procedure time for modified POEM was significantly shorter than that for traditional POEM. CONCLUSIONS: Modified POEM with short submucosal tunneling may be more efficient than traditional POEM with long submucosal tunneling, and outcomes may be equivalent over short-term follow-up. Long-term data and randomized controlled studies are needed to compare the clinical efficacy of modified POEM with that of the traditional method.

Cannulation time is a more accurate measure of cannulation difficulty in endoscopic retrograde cholangiopancreatography than the number of attempts.

BACKGROUND: Cannulation of the common bile duct (CBD) is the initial and sometime challenging step in endoscopic retrograde cholangiopancreatography (ERCP) procedure. Endoscopists often use cannulation attempts and cannulation time to grade cannulation difficulty, but a standard system has yet to be established. The objective of this study was to compare cannulation times with numbers of cannulation attempts, as measures of cannulation difficulty. METHODS: We conducted a prospective study in a tertiary referral center, enrolling 58 patients who were undergoing ERCP for a variety of indications. Cannulation time and the number of cannulation attempts were recorded for each patient. A subset of 14 ERCPs had two observers assessing attempts at cannulation. Cannulation time, number of attempts and inter-observer variability in assessment of attempts were compared and studied. RESULTS: The degree of agreement between two the methods (cannulation times and number of cannulation attempts) was unacceptable. There were considerable discrepancies between attempt tallies from two observers but the mean difference was statistically insignificant. CONCLUSION: The grade of cannulation difficulty for a given ERCP procedure may differ when different methods are used (total cannulation time vs number of attempts); thus, grading by different methods should not be used interchangeably. Cannulation time is a more objective and more accurate assessment tool for grading cannulation difficulty than the number of attempts to cannulate the papilla.

Advances in endoscopic retrograde cholangiopancreatography cannulation.

Endoscopic retrograde cholangiopancreatography is an important tool in the diagnosis and treatment of pancreatobiliary diseases. A critical step in this procedure is deep cannulation of the bile duct as failure of cannulation generally results in an aborted procedure and failed intervention. Expert endoscopists usually achieve a high rate of successful cannulation while those less experienced typically have a much lower rate and a greater incidence of complications. Prolonged attempts at cannulation can result in significant morbidity to patients, anxiety for endoscopists, unnecessary radiation exposure and inefficient patient care. Here we review the most common endoscopic techniques used to achieve selective biliary cannulation. Pharmacologic aids to cannulation are also discussed briefly in this review.