Abnormal response after multiple rapid swallow provocation is not predictive of post-operative dysphagia following a tailored fundoplication approach.

INTRODUCTION: The aim was to evaluate the clinical significance of multiple rapid swallows (MRS) during high-resolution manometry (HRM) prior to fundoplication. Despite pre-operative HRM, up to 38% of patients report post-fundoplication dysphagia. Suggestion that MRS improves prediction of dysphagia after fundoplication has not been investigated when using a tailored approach. We hypothesize response to MRS is predictive of dysphagia after tailored fundoplication. METHODS: A retrospective cohort study was performed on patients undergoing HRM with MRS provocation 5/2019-7/2021 at a single institution. Patients who underwent subsequent index laparoscopic fundoplication, without peptic stricture or achalasia, were included. After performing standard 10-swallow HRM, MRS provocation was performed. Patient-reported dysphagia frequency scores were collected at initial consultation and post-operative follow-up. At least weekly symptoms were considered clinically significant. Normal MRS response was defined as adequate deglutitive inhibition and MRS contractile response. Fundoplications were tailored based on standard HRM values. RESULTS: HRM was performed in 1201 patients, 220 met inclusion criteria. Clinically significant pre-operative dysphagia was reported by 85 (38.6%). Patients undergoing partial fundoplication (n = 123, 55.9%) had lower mean distal contractile integer, distal esophageal contraction amplitude, and percent peristalsis (p < 0.005). Post-operatively, 120 (54.5%) were without dysphagia, 59 (26.8%) had improved dysphagia, 26 (11.8%) had unchanged dysphagia, and 15 (6.8%) reported new dysphagia. There was no statistical difference in early or late dysphagia outcome between tailored fundoplication groups (p = 0.69). On univariate and multivariate analysis, neither MRS response, nor standard HRM metrics were significantly associated with post-operative dysphagia. Younger age (OR 0.96, 95% CI 0.94-0.986, p = 0.042) and the presence of pre-operative dysphagia (OR 2.54, 95% CI 1.17-5.65, p = 0.015) were significant predictors of post-operative dysphagia. CONCLUSION: The risk of clinically significant dysphagia post-fundoplication is low when using a tailored approach based on standard HRM metrics. Additional data provided by MRS does not add to surgical decision-making using the investigated approach.

Diaphragmatic relaxing incisions for complex hiatal reconstruction: longer-term follow-up confirms safety, efficacy and rare complications.

BACKGROUND: Tension is an important factor in hernia repairs. Relaxing incisions to reduce tension are common with ventral hernia repairs, and techniques for relaxing incisions also exist for the hiatus. The aim of this study was to update our original experience with a diaphragm relaxing incision (DRI) in a larger group of patients with longer follow-up. METHODS: A retrospective chart review was performed to identify all patients who had a DRI between August 2016 and September 2021 during hiatal hernia repair. All DRI defects were repaired with permanent mesh remote from the esophagus. Objective follow-up was with chest x-ray, upper GI series (UGI) or both. RESULTS: Seventy-three patients had a total of 79 DRI (right in 63, left in 4, and bilateral in 6 patients), during a primary (n = 52) or redo (n = 21) hiatal hernia repair. Concomitant Collis gastroplasty was used in 38 patients (52%). A single intra-operative complication occurred where the right crus tore during a right DRI. At a median of 15 months, 78% of patients had objective follow-up. There was one hernia through a repaired right DRI (1.2%). No patient had evidence of diaphragm paralysis and there were no mesh infections. The 1-year hernia recurrence rate in these patients was 3.9%. CONCLUSIONS: A DRI can be done safely with minimal risk of intra- or post-operative complications. There was a low rate of herniation through the defect when repaired with permanent mesh. No patient developed a mesh infection despite concomitant Collis gastroplasty in 52% of patients, and there was no evidence of diaphragm paralysis on imaging studies. Further, the low rate of hiatal hernia recurrence suggests efficacy of a DRI to reduce crural closure tension. These excellent outcomes should encourage use of a DRI in patients with a difficult hiatus during hernia repair.

The Development and Natural History of Hiatal Hernias: A Study Using Sequential Barium Upper Gastrointestinal Series.

OBJECTIVE: The aim of this study was to use barium upper gastrointestinal series (UGI) to evaluate the development and natural history of a hiatal hernia. SUMMARY OF BACKGROUND DATA: Hiatal hernias are common but the natural history of sliding and paraesophageal type hernias is poorly understood. METHODS: We reviewed UGI reports from 1987 to 2017 using a word scanning software program to identify individuals that had a hiatal hernia. Only those with at least 2 UGI studies 5 or more years apart were selected. The studies were then reviewed. RESULTS: There were 89 individuals that met inclusion criteria. Twenty-one people had no hiatal hernia on initial UGI and over a median of 99 months a sliding hiatal hernia (SHH) developed in 16 and a PEH developed in 5 people. A SHH was present on initial UGI in 55 people and at a median of 84 months subsequent UGI showed the SHH was stable in 11 (20%), increased in size in 30 (55%), and changed to a PEH in 14 people (25%). In 13 people a PEH was present on initial UGI and over a median of 97 months it was stable in 5 and increased in size in 8 people (62%). CONCLUSIONS: We showed that both SHH and PEH can develop over time and that the majority of both increased in size on follow-up UGI study. Further, 25% of SHH became a PEH over time. Recognizing an increase in size or change in type of a hiatal hernia may be clinically relevant to help understand changing or worsening symptoms in an individual.

High Resolution Manometry in a Functioning Fundoplication - Establishing a Standard Profile: Retrospective Chart Review.

OBJECTIVE: The aim of this study was to provide a full HRM data set in patients with a normal functioning fundoplication. BACKGROUND: The Chicago classification was devised to correlate HRM values to the clinical status of patients with swallowing disorder. However, it is unclear whether those values are applicable after fundoplication as the literature is sparse. METHODS: We identified patients with pre- and postoperative HRM who had a normal functioning primary fundoplication as defined by (1) resolution of preoperative symptoms without significant postoperative side effects, (2) no dysphagia reported on a standardized questionnaire given on the day of the postoperative HRM and (3) normal acid exposure determined objectively by esophageal pH-testing. RESULTS: Fifty patients met inclusion criteria for the study. Thirty-three patients (66%) underwent complete fundoplication and 17 patients (34%) underwent posterior partial fundoplication. Postoperative HRM was performed at a median of 12 months after primary surgery. Lower esophageal sphincter (LES) values significantly increased with the addition of a fundoplication. Median integrated relaxation pressure (IRP) was 14 mm Hg ( P = 0.0001), median resting pressure 19.5 mm Hg ( P = 0.0263), and median total length LES was 3.95 cm ( P = 0.0098). The 95th percentile for IRP in a complete fundoplication was 29 versus 23 mm Hg in a partial fundoplication ( P = 0.3667). CONCLUSION: We offer a new standard manometric profile for a normally functioning fundoplication which provides a necessary benchmark for analyzing postoperative problems with a fundoplication. The previously acceptedupper limit defining esophageal outflow obstruction (IRP >20 mm Hg) is not clinically applicable after fundoplication as the majority of patients in this dysphagia-free cohort exceeded this value. Interestingly, there does not seem to be a significant difference in HRM LES values between complete and partial fundoplication.

POEM: clinical outcomes beyond 5 years.

BACKGROUND: The short-term success of peroral endoscopic myotomy (POEM) is well documented but the durability of the operation is questioned. The aim of this study was to evaluate the clinical outcomes of the POEM procedure for esophageal motility disorders in a large cohort in which all patients had at least 5 years of follow-up. METHODS: All patients from a single center who underwent a POEM between October 2010 and September 2014 were followed for long-term clinical outcomes. Postoperative Eckardt symptom scores of short term and ≥ 5 years were collected through phone interview. Clinical success was defined as an Eckardt score < 3. Overall success was defined as Eckardt score < 3 and freedom from additional interventions. RESULTS: Of 138 patients, 100 patients were available for follow-up (mean age 56, 52% male). The indication for operation was achalasia in 94. The mean follow-up duration was 75 months (range: 60-106 months). Dysphagia was improved in 91% of patients. Long-term overall success was achieved in 79% of patients (80% of achalasia patients, 67% of DES patients). Preoperative mean Eckardt score was 6. At 6 months, it was 1, and at 75 months, it was 2 (p = 0.204). Five-year freedom from intervention was 96%. Overall, 7 patients had additional treatments: 1 balloon dilation (35 mm), 4 laparoscopic Heller myotomy, and 2 redo POEM at a mean of 51 months post-POEM. Ninety-three percent expressed complete satisfaction with POEM. CONCLUSION: A multitude of studies has shown the early benefits of POEM. Here, we show that nearly 80% of patients report clinical success with no significant decrement in symptom scores between their short- and long-term follow-up. Clearly POEM is an effective option for achalasia with durable long-term treatment efficacy.

Safety and efficacy of magnetic sphincter augmentation dilation.

BACKGROUND: The magnetic sphincter augmentation device (MSA) provides effective relief of gastroesophageal reflux symptoms. Dysphagia after MSA implantation sometimes prompts endoscopic dilation. The manufacturer's instructions are that it be performed 6 or more weeks after implantation under fluoroscopic guidance to not more than 15 mm keeping 3 or more beads closed. The purpose of this study was to assess adherence to these recommendations and explore the techniques used and outcomes after MSA dilation. METHODS AND PROCEDURES: We conducted a multicenter retrospective review of patients undergoing dilation for dysphagia after MSA placement from 2012 to 2018. RESULTS: A total of 144 patients underwent 245 dilations. The median size of MSA placed was 14 beads (range 12-17) and the median time to dilation was 175 days. A second dilation was performed in 67 patients, 22 patients had a third dilation and 7 patients underwent 4 or more dilations. In total, 17 devices (11.8%) were eventually explanted. The majority of dilations were performed with a balloon dilator (81%). The median dilator size was 18 mm and 73.4% were done with a dilator larger than 15 mm. There was no association between dilator size and need for subsequent dilation. Fluoroscopy was used in 28% of cases. There were no perforations or device erosions related to dilation. DISCUSSION: There is no clinical credence to the manufacturer's recommendation for the use of fluoroscopy and limitation to 15 mm when dilating a patient for dysphagia after MSA implantation. Use of a larger size dilator was not associated with perforation or device erosion, but also did not reduce the need for repeat dilation. Given this, we would recommend that the initial dilation for any size MSA device be done using a 15 mm through-the-scope balloon dilator. Dysphagia prompting dilation after MSA implantation is associated with nearly a 12% risk of device explantation.

Long-term outcomes following POEM for non-achalasia motility disorders of the esophagus.

BACKGROUND: Optimal treatment for symptomatic patients with non-achalasia motility disorders (NAD) such as diffuse esophageal spasm, esophagogastric junction outlet obstruction, and hypercontractile disorder is not well established. POEM has been offered to these patients since it is a less invasive and less morbid procedure but long-term outcomes remain undetermined. The aim of this study was to assess long-term outcomes of POEM for patients with NAD. METHODS: Records of 40 consecutive patients undergoing POEM for NAD from May 2011 to January 2016 at a single center were retrospectively reviewed. Preoperative and 6-month postoperative symptom scores, high-resolution manometry, pH testing, and timed barium swallow (TBS) data were collected. Patients were contacted by phone to obtain long-term symptom assessment. Symptoms were assessed using a standardized symptom questionnaire with scores for symptoms graded according to frequency and the Eckardt score. RESULTS: Ten percent had minor complications with no postoperative sequelae. 90% of patients had significant improvement in their mean Eckardt scores (5.02 vs. 1.12, p < 0.001) at early follow-up. Improvements in chest pain (1.02-0.36, p = 0.001) and dysphagia (2.20 vs. 0.40, p = 0.001) were seen. Significant improvements in manometric pressures and esophageal emptying on TBS were observed across groups. 38% (10/26) of patients had a postoperative pH score > 14.72. Long-term (median 48 months) symptom scores were obtained from 29 (72.5%) patients. 82% of patients (24/29) had sustained symptom improvement. A small increase in the dysphagia scores was reported in the long-term follow-up compared to the immediate postoperative period (0.36-0.89, p = 0.046). CONCLUSIONS: Chest pain and dysphagia are effectively palliated with POEM in patients with non-achalasia disorders of the esophagus. Significant improvements are durable in long-term follow-up. Despite earlier reports by our group suggesting possible inferior outcomes from POEM for this difficult group of patients, this study is far more encouraging. POEM should be considered in the treatment of patients with non-achalasia disorders of the esophagus.

SAGES review of endoscopic and minimally invasive bariatric interventions: a review of endoscopic and non-surgical bariatric interventions.

BACKGROUND: With obesity continuing as a global epidemic and therapeutic technologies advancing, several novel endoscopic and minimally invasive interventions will likely become available as treatment options. With improved technologies and different treatment strategies, as well as different patient populations being targeted, there will be greater application in the treatment armamentarium of specialists dedicated to treating obesity. We sought to review the existing technology and provide a review. METHODS: Literature review was carried out for endoscopic and minimally invasive devices. Some of these products are not FDA approved, so limited data are available in their review. RESULTS: A summary of the device and data currently available on weight loss and safety profile is provided. Several products are in clinical trials or will be soon. Some of the technology has limited data and companies will be submitting their results for FDA evaluation. CONCLUSIONS: The obesity epidemic and associated weight-related diseases represent a tremendous burden to health care practitioners. As such, a multi-modal and progressive approach, with data and outcomes examined, is likely the best and most comprehensive method to care for these patients. SAGES endorses the benefits of minimally invasive and endoscopic approaches in the treatment of obesity and its related co-morbidities.

Impedance-pH monitoring on medications does not reliably confirm the presence of gastroesophageal reflux disease in patients referred for antireflux surgery.

INTRODUCTION: The gold standard for the objective diagnosis of gastroesophageal reflux disease (GERD) is ambulatory-pH monitoring off medications. Increasingly, impedance-pH (MII-pH) monitoring on medications is being used to evaluate refractory symptoms. The aim of this study was to determine whether an MII-pH test on medications can reliably detect the presence of GERD. METHODS: Patients referred for persistent reflux symptoms despite pH confirmed adequate acid suppression (DeMeester score ≤14.7) were reviewed retrospectively. All patients who originally had MII-pH testing on medications were re-evaluated with an off medication Bravo-pH study. Acid exposure results (defined by off medication Bravo) were compared to the original on medication MII-pH. RESULTS: There were 49 patients who met study criteria (median age 51). Patients had normal acid exposure during their MII-pH test on medications (average DMS 4.35). Impedance was abnormal (normal ≤47) in 25 of the 49 patients (51%). On subsequent Bravo-pH off medications, 37 patients (75.7%) showed increased esophageal acid exposure (average DMS 36.4). Bravo-pH testing was abnormal in 84% of patients with abnormal MII testing and in 67% with normal MII testing. The sensitivity and specificity of an abnormal MII-pH on medications for increased esophageal acid exposure off medications was 56.8 and 66.7%, respectively. The positive predictive value of confirming GERD from an abnormal MII-pH on medications is 84%, while the negative predictive value is 33.3%. A receiver operating characteristic (ROC) curve was generated and the area under the curve was 0.71, indicating that MII-pH on medications is a fair test (0.7-0.8) in diagnosing pathologic GERD. CONCLUSION: Compared to the gold standard, MII-pH on medications does not reliably confirm the presence of GERD. Excellent outcomes with antireflux surgery are dependent on the presence of GERD; thus, patients should not be offered antireflux surgery until GERD is confirmed with pH testing off medications.

Endoscopic resection of giant fibrovascular esophageal polyps.

BACKGROUND: Giant fibrovascular esophageal polyps are rare benign intraluminal tumors that originate from the submucosa of the cervical esophagus [Owens et al. (JAMA 103: 838-842, 1994), Totten et al. (JAMA 25:606-622, 1953)]. Due to their indolent course, these tumors tend to reach enormous proportions before patients develop symptoms. Accurately diagnosing these tumors is difficult, as endoscopy may miss 25% of these lesions because these polyps exhibit normal intact esophageal mucosa [Levine et al. (JAMA 166: 781-787, 1996)]. METHODS: Surgical resection has been the treatment of choice. We present a video that illustrates the feasibility of an endoscopic approach. TECHNIQUE/CASE: A 62-year-old man presented to our clinic with a pedunculated esophageal mass. During this time, he developed progressive dysphagia to solid foods. A complete workup confirmed the presence of a giant polyp and endoscopic resection under general anesthesia was planned. Using an endoscopic snare-technique, a 16 cm × 3 cm polyp was amputated and retracted out of the oropharynx. Upon repeat endoscopy a second 7 cm × 3 cm polyp was discovered originating proximal to the larger polyp. Again, removal of this polyp was attempted using a snare-technique. Following amputation of the polyp, a broad-based component of the polyp remained. Given its proximal location in the esophagus, we were able to use a snare to pull the broad base of the remaining polyp into the oropharynx and remove it at its origin. Postoperative endoscopy and endoscopic ultrasound confirmed that the polyps were completely removed and the muscular resection bed was hemostatic. Clinically, the patient's symptoms resolved and he encountered no adverse sequela as a result of the operation. CONCLUSION: Giant fibrovascular esophageal polyps are rare benign intraluminal tumors that can lead to obstructive symptoms. Surgical resection is the treatment of choice, and may be possible with an endoscopic approach. An endoscopic snare technique can be used to resect these lesions while minimizing patient morbidity.

Clinical outcomes five years after POEM for treatment of primary esophageal motility disorders.

BACKGROUND: Peroral endoscopic myotomy (POEM) is a novel operation for the treatment of achalasia and other esophageal motility disorders. While POEM has shown excellent short-term safety and efficacy, the long-term symptomatic outcomes after the procedure are unknown. METHODS: Patients from a single center that underwent POEM for treatment of esophageal motility orders and were greater than 5 years removed from their operation were studied. Patients were contacted to assess current symptoms and encouraged to undergo repeat endoscopy for objective follow-up. RESULTS: Thirty-six patients underwent POEM from October, 2010 to February, 2012 and current symptom scores were obtained from 29 patients at median 65-month follow-up. In the 23 patients with achalasia, Eckardt scores were significantly improved from preoperative baseline (mean current 1.7 vs. preoperative 6.4, p < 0.001). Nineteen patients (83%) with achalasia had a symptomatic success (Eckardt ≤3) and none required retreatment for symptoms. Eckardt scores were dramatically improved at 6 months and maintained at 2 years; however, there was a small but significant worsening of symptoms between 2 and 5-years. Of the five patients with EGJ outflow obstruction, all had current Eckardt scores ≤3 but two needed reintervention for persistent or recurrent symptoms, one with a laparoscopic Heller myotomy and another with an endoscopic cricomyotomy and proximal esophageal myotomy extension. At 6-month follow-up, repeat manometry showed decreased EGJ relaxation pressures and esophagram demonstrated improved emptying. 24-h pH monitoring showed abnormal distal esophageal acid exposure in 38% of patients. Fifteen patients underwent endoscopy at 5-years, revealing erosive esophagitis in two (13%), new hiatal hernia in two, and new non-dysplastic Barrett's esophagus in one. The patient with Barrett's underwent a subsequent laparoscopic hiatal hernia repair and Toupet fundoplication. CONCLUSIONS: POEM resulted in a successful palliation of symptoms in the majority of patients after 5 years, though these results emphasize the importance of long-term follow-up in all patients.

Peroral endoscopic myotomy as salvation technique post-Heller: International experience.

BACKGROUND: Treatment for achalasia has traditionally been Heller myotomy (HM). Despite its excellent efficacy rate, a number of patients remain symptomatic post-procedure. Limited data exist as to the best management for recurrence of symptoms post-HM. We present an international, multicenter experience evaluating the efficacy and safety of post-HM peroral endoscopic myotomy (POEM). METHODS: Patients who underwent POEM post-HM from 13 centers from January 2012 to January 2017 were included as part of a prospective registry. Technical success was defined as successful completion of the myotomy. Clinical success was defined as an Eckardt score of ≤3 on 12-month follow up. Adverse events (AE) including anesthesia-related, operative, and postoperative complications were recorded. RESULTS: Fifty-one patients were included in the study (mean age 54.2, 47% male). Technical success was achieved in 100% of patients. Clinical success on long-term follow up was achieved in 48 patients (94%), with a mean change in Eckardt score of 6.25. Seven patients (13%) had AE: six experienced periprocedural mucosal defect treated endoscopically and two patients developed mediastinitis treated conservatively. CONCLUSION: For patients with persistent symptoms after HM, POEM is a safe salvation technique with good short-term efficacy. As a result of the challenge associated with repeat HM, POEM might become the preferred technique in this patient population. Further studies with longer follow up are needed.

Comprehensive Analysis of Adverse Events Associated With Per Oral Endoscopic Myotomy in 1826 Patients: An International Multicenter Study.

OBJECTIVES: The safety of peroral endoscopic myotomy (POEM) is still debated since comprehensive analysis of adverse events (AEs) associated with the procedure in large multicenter cohort studies has not been performed. To study (1) the prevalence of AEs and (2) factors associated with occurrence of AEs in patients undergoing POEM. METHODS: Patients who underwent POEM at 12 tertiary-care centers between 2009 and 2015 were included in this case-control study. Cases were defined by the occurrence of any AE related to the POEM procedure. Control patients were selected for each AE case by matching for age, gender, and disease classification (achalasia type I and II vs. type III/spastic esophageal disorders). RESULTS: A total of 1,826 patients underwent POEM. Overall, 156 AEs occurred in 137 patients (7.5%). A total of 51 (2.8%) inadvertent mucosotomies occurred. Mild, moderate, and severe AEs had a frequency of 116 (6.4%), 31 (1.7%), and 9 (0.5%), respectively. Multivariate analysis demonstrated that sigmoid-type esophagus (odds ratio (OR) 2.28, P=0.05), endoscopist experience <20 cases (OR 1.98, P=0.04), use of a triangular tip knife (OR 3.22, P=0.05), and use of an electrosurgical current different than spray coagulation (OR 3.09, P=0.02) were significantly associated with the occurrence of AEs. CONCLUSIONS: This large study comprehensively assessed the safety of POEM and highly suggests POEM as a relatively safe procedure when performed by experts at tertiary centers with an overall 7.5% prevalence of AEs. Severe AEs are rare. Sigmoid-type esophagus, endoscopist experience, type of knife, and current used can be considered as predictive factors of AE occurrence.

A multicenter international registry of redo per-oral endoscopic myotomy (POEM) after failed POEM.

BACKGROUND AND AIMS: Per-oral endoscopic myotomy (POEM) has become an accepted treatment for patients with achalasia. Despite its excellent efficacy rate of greater than 80%, a small percentage of patients remain symptomatic after the procedure. Limited data exist as to the best management for recurrence of symptoms after POEM. We present the first international, multicenter experience on the efficacy and safety of a repeat POEM in the management of achalasia. METHODS: Patients who underwent a redo POEM from 15 centers in 9 countries were included in a dedicated registry. Technical success was defined as successful completion of a second myotomy. Clinical success was defined as an Eckardt score of less than or equal to 3 after the second myotomy. Adverse events including anesthesia-related, operative, and postoperative adverse events were recorded. RESULTS: Forty-six patients were included in the study. The average age was 49.3 ± 16.78 years. Twenty (45%) patients were male. The mean pre-redo-POEM Eckardt score was 4.3 ± 2.48. Technical success was achieved in 46 (100%) patients. Clinical success was achieved in 41 patients (85%). The average post-POEM Eckardt score was 1.64 ± 1.67, with a significant difference of 2.58 (P < .00001). Eight patients (17%) had adverse events consisting of procedural bleeding, all managed endoscopically. There were no deaths. No POEMs were aborted or required surgical conversion or assistance. DISCUSSION: For patients with persistent symptoms after POEM, repeat POEM appears to be an efficacious and safe technique. Further randomized trials comparing redo POEM versus Heller should be considered. (Clinical trial registration number: NCT02162589.).

Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial.

BACKGROUND & AIMS: Transoral esophagogastric fundoplication (TF) can decrease or eliminate features of gastroesophageal reflux disease (GERD) in some patients whose symptoms persist despite proton pump inhibitor (PPI) therapy. We performed a prospective, sham-controlled trial to determine if TF reduced troublesome regurgitation to a greater extent than PPIs in patients with GERD. METHODS: We screened 696 patients with troublesome regurgitation despite daily PPI use with 3 validated GERD-specific symptom scales, on and off PPIs. Those with at least troublesome regurgitation (based on the Montreal definition) on PPIs underwent barium swallow, esophagogastroduodenoscopy, 48-hour esophageal pH monitoring (off PPIs), and high-resolution esophageal manometry analyses. Patients with GERD and hiatal hernias ≤2 cm were randomly assigned to groups that underwent TF and then received 6 months of placebo (n = 87), or sham surgery and 6 months of once- or twice-daily omeprazole (controls, n = 42). Patients were blinded to therapy during follow-up period and reassessed at 2, 12, and 26 weeks. At 6 months, patients underwent 48-hour esophageal pH monitoring and esophagogastroduodenoscopy. RESULTS: By intention-to-treat analysis, TF eliminated troublesome regurgitation in a larger proportion of patients (67%) than PPIs (45%) (P = .023). A larger proportion of controls had no response at 3 months (36%) than subjects that received TF (11%; P = .004). Control of esophageal pH improved after TF (mean 9.3% before and 6.3% after; P < .001), but not after sham surgery (mean 8.6% before and 8.9% after). Subjects from both groups who completed the protocol had similar reductions in GERD symptom scores. Severe complications were rare (3 subjects receiving TF and 1 receiving the sham surgery). CONCLUSIONS: TF was an effective treatment for patients with GERD symptoms, particularly in those with persistent regurgitation despite PPI therapy, based on evaluation 6 months after the procedure. Clinicaltrials.gov no: NCT01136980.

Covered stents in cervical anastomoses following esophagectomy.

INTRODUCTION: Anastomotic complications after esophagectomy are relatively frequent. The off-label use of self-expanding covered metal stents has been shown to be an effective initial treatment for leaks, but there is a paucity of literature regarding their use in cervical esophagogastric anastomoses. We reviewed our outcomes with anastomotic stenting after esophagectomy with cervical esophagogastric reconstruction. METHODS: All stents placed across cervical anastomoses following esophagectomy from 2004 to 2014 were retrospectively reviewed. Indications for surgery and stent placement were collected. For patients with serial stents, each stent event was evaluated separately and as part of its series. Success was defined as resolution of indicated anastomotic problem for at least 90 days. Complications were defined as development of stent-related problems. RESULTS: Twenty-three patients had a total of 63 stents placed (16 % prophylactic, 38 % leak, 46 % stricture). Sixty percent of patients had successful resolution of their initial anastomotic problem; 67 % required more than one stent. Strictures and leaks healed in 27 and 70 % of patients, respectively, at a median of 55.5 days. Stent-related complications occurred in 78 % of patients. Complications (per stent event) included 62 % migration, 11 % clinically significant tissue overgrowth, 8 % minor erosion (ulcers), and 8 % major erosion. Stents placed for stricture were more likely to result in complications, especially migration (76.7 vs. 48.5 %, p = 0.02). Preoperative chemoradiation was a significant risk factor for erosion (22.5 vs. 4.3 %, p = 0.05), but not for overall complications. Patients with major erosions had longer stent duration compared to those without (92 vs. 36 days, p = 0.14). DISCUSSION: Although stents are effective at controlling post-esophagectomy anastomotic leaks, they are not effective for treating strictures. Stents have high complication rates, but most are minor. Chemoradiation is a risk factor for stent erosion. Caution should be used when stent duration exceeds 2-3 months due to the risk of erosion.

Endoscopic treatment for iatrogenic achalasia post-laparoscopic adjustable gastric banding.

BACKGROUND: Esophageal obstruction is a known complication of laparoscopic adjustable gastric band (LAGB) and usually occurs in the context of band slippage. Current reports of pseudoachalasia post-LAGB describe that in some patients esophageal function improves after band removal. For those without improvement, current treatments include division of the fibrotic band post-LAGB or revisional surgery. Our hypothesis, illustrated in the submitted video, is that an endoscopic division of LAGB-induced stricture will improve esophageal function. METHODS: This video presents the case of a patient presenting with dysphagia post-LAGB removal. The preoperative high-resolution manometry was compatible with a type I achalasia. Using a high-definition endoscope and the equipment used for per-oral endoscopic myotomy (POEM) procedure, the intramural fibrotic tissue caused by the LAGB is divided, thus releasing the stricture and restoring baseline esophageal function. This is demonstrated with intraoperative endoscopic functional lumen imaging probe (EndoFLIP; Crospon Ltd, Galway, Ireland). RESULTS: Similar to the POEM technique, a 12-cm tunnel and 8-cm myotomy were performed. No intra-procedural or post-procedural complications were noted. Using impedance planimetry, the division of the LAGB-induced stricture induced an increase in the minimal diameter from 5.3 to 8.6 mm. The cross-sectional area increased from 22 to 58 mm(2). The patient denies any residual dysphagia, regurgitation, or heartburn at 6-month follow-up. On the postoperative high-resolution manometry, significant improvement in LES pressure parameters was seen post-myotomy with return of 30 % peristalsis. DISCUSSION: In LAGB patients with pseudoachalasia in which removal of fluid from the band does not result in clinical or manometric improvement, laparoscopic removal of the band with division of the peri-esophageal scar tissue has been advocated. This video illustrates that an endoscopic division of the LAGB-induced esophageal fibrosis is another potential treatment for adjustable gastric band-induced achalasia.

Hill procedure for recurrent GERD post-Roux-en-Y gastric bypass.

BACKGROUND: Roux-en-Y gastric bypass (RYGB) is considered to be an optimal surgical treatment option for GERD in the morbidly obese patient. Nevertheless, a subgroup of patients suffer from recurrent or persistent GERD after their gastric bypass. Unfortunately, limited treatment options are available in these patients. Fundoplication via mobilization of the remnant stomach and radiofrequency treatment of the lower esophageal sphincter have been described with some success. Our objective is to illustrate a safe and durable surgical option in the treatment of patients with medically refractory GERD post-RYGB. METHODS: After placing five trocars in the usual position for a foregut laparoscopic surgery, a lysis of adhesions and standard dissection of the hiatus is performed. The anterior and posterior vagal nerves associated phrenoesophageal tissue bundles are identified. A primary crural repair with interrupted nonabsorbable sutures is performed. Four full-length nonabsorbable sutures are placed sequentially through the anterior and posterior phrenoesophageal bundle, posterior fundus and finally through the pre-aortic fascia. The repair is calibrated on a 44 French bougie. The sutures are tied from medial to lateral in the order of their placement under endoscopic guidance. RESULTS: No peri-procedural complications were encountered. Standard post-antireflux surgery clinical follow-up with the patient completing a validated GERD clinical questionnaire at 1 and 6 months after the surgery demonstrated excellent GERD symptom control without any dysphagia. A pH study and EGD performed at 6 months post-Hill procedure show the absence of pathological reflux with an intact Hill mechanism. CONCLUSION: The Hill procedure is a valid treatment for the post-bariatric surgical patient with GERD in which the gastric fundus is absent or inaccessible thus eliminating standard fundoplication as a reasonable option. This also represents a safe and durable treatment of GERD in this uniquely challenging patient population.

Trans-oral cricomyotomy using a flexible endoscope: technique and clinical outcomes.

INTRODUCTION: Zenker's diverticulum (ZD) is a rare upper esophageal pathology that is most prevalent in the sixth and seventh decade. Three different therapeutical options are available: (1) open trans-cervical approach, (2) rigid endoscopy and (3) flexible endoscopy. Our hypothesis is that a flexible endoscopic cricomyotomy represents a safe and effective treatment of ZD as well as cricopharyngeal spasm. METHODS: A retrospective analysis of all patients that underwent a flexible endoscopic cricomyotomy at our institution between October 2008 and May 2014 was performed. Preoperative and postoperative (1 month and long-term follow-up) symptom scores and clinical outcomes were collected. Briefly, the ZD is carefully identified endoscopically and the common wall is divided using needle knife cautery with the help of an endoscopic cap. Clips are used to close the mucosal defect starting with the apex. RESULTS: Twenty-six patients underwent a flexible endoscopic myotomy for a ZD. Of 26 patients, five (19.2 %) had a history of previous open or stapled trans-oral myotomy and four (15.4 %) underwent a concomitant foregut procedure. Mean length of stay was 1.5 days (range 1-11). Mean operative time was 68 min (range 28-149). One patient presented with a postoperative leak, and one patient presented with a retained clip. Both were treated endoscopically. Recurrent weekly dysphagia was present in 3/26 (11.5 %). One patient (3.8 %) underwent an endoscopic bougie dilatation postoperatively. With regard to clinical outcomes, there was a statistically significant improvement in both short-term (1 month) and long-term (median follow-up 21.8 months; range 1-68.2 months) dysphagia (p < 0.001; p < 0.001), regurgitation (p = 0.001; p = 0.017), cough (p = 0.006; p = 0.025) and aspiration (p = 0.013; p = 0.013). CONCLUSION: Flexible endoscopic cricomyotomy offers durable relief of dysphagia, regurgitation, cough and aspiration in ZD patients. It appears to have a good safety profile with symptomatic recurrence occurring in up to 11.5 % of cases.