Endoscopic Plication Research Articles

Endoscopic revision of gastric bypass: Holy Grail or Epic fail?

Approximately 20-30% of patients who undergo Roux-en-Y gastric bypass (RYGB) will not meet the goals of weight loss surgery. Revisional surgery is associated with higher morbidity compared to initial operative management, and results in terms of weight loss have been inconsistent. Endoscopic plication has been seen as a less invasive option, with encouraging initial results. The objective was to analyze the outcomes after Restorative Obesity Surgery, Endolumenal (ROSE) procedure. We retrospectively analyzed patients who underwent ROSE between 5/2008 and 11/2013. All patients had failure of weight loss or regain weight after RYGB. Demographics, operative data, and follow-up were recorded. Twenty-seven patients underwent ROSE. One patient was excluded due to lack of follow-up. Twenty-five (96%) patients were female. Mean time since initial RYGB was 11.9±4.3years. Mean initial weight and BMI were 236±47lb and 40.6±8.1kg/m(2), respectively. Mean OR time was 77±30min. Preoperative average pouch length and stoma diameter were 6.8±2.3 and 2.1±0.7cm, respectively. On average, 4±1.6 stitches were placed. Final pouch length and stoma diameter were 3.4±1.6 (50% reduction) and 0.86±0.4cm (61% reduction). A total of 12 (46%) and seven (28%) patients underwent EGD at 3 and 12months postoperatively. The mean pouch length and stoma diameter were 5±1.9 (26.5% reduction) and 1.2±0.7cm (42.9% reduction) at 3months and 6.14±1.6 (10% reduction) and 2.2±1.2cm (4.7% increase) at 12months, respectively. The %EWL was 8.9, 9.3, 8, 6.7, -10.7, -13.5, -5.8, -4.5 at 3, 6, 12, 24, 36, 48, 60, and 72months, respectively. Although endoscopic plication achieved the intended reduction in the pouch and stoma diameter at 3months, these tend toward the preoperative diameter at 12months. This anatomical failure and the lack of follow-up may explain why most patients failed to achieve sustainable weight loss.

Critical Assessment of Endoscopic Techniques for Gastroesophageal Reflux Disease.

Over the past 2 decades, a number of new endoscopic techniques have been developed for management of gastroesophageal (GE) reflux disease symptoms as alternatives to medical management and surgical fundoplication. These devices include application of radiofrequency treatment (Stretta), endoscopic plication (EndoCinch, Plicator, Esophyx, MUSE), and injection of bulking agents (Enteryx, Gatekeeper, Plexiglas, Duragel). Their goal was symptom relief through reduction of tissue compliance and enhancement of anatomic resistance at the GE junction. In this review, we critically assess the research behind the efficacy, safety, and durability of these treatments to better understand their roles in contemporary GE reflux disease management.

Lassoing of the small bowel mesentery and abdominal pain caused by band tubing after “band on bypass”

Weight regain after laparoscopic gastric bypass can be difficult to manage. A common finding is an enlarged gastrojejunal complex (dilated gastric pouch and/or jejunum, dilated gastrojejunal anastomosis). Revision of the gastrojejunal complex can be accomplished by surgical resection [1], endoscopic plication techniques [2], or more recently, placement of an adjustable band around the dilated gastric pouch (“band on bypass,” BoB). We present an unusual complication of the BoB procedure, in which the band tubing looped around the small bowel causing severe abdominal pain.

Tu1641 Endoscopic Suturing Devices and Injection Teraphy on GERD: Prospective Study With Late Follow-Up (60 Months)

Several studies regarding endoscopic treatment of GERD were published on the 90's with the intention to reduce gastro-esophageal reflux and diminish the use of acid-suppressing drugs. The appealing immediate results of these therapies that are also minimally invasive characteristics determined our goal to assess the long-term follow up of these patients. Objective: Assess the effectiveness of injection therapy with an inert polymer (G0) and endoscopic plication (G1) on GERD treatment on long-term follow-up (60months).

Endoscopic full-thickness plication versus laparoscopic fundoplication: a prospective study on quality of life and symptom control

Endoscopic antireflux techniques have emerged as alternative therapies for gastroesophageal reflux disease (GERD). Endoscopic plication receives continuing interest as an effective and safe procedure. This treatment option has not been the subject of comparison with well-established operative therapies to date. The present study aimed at comparatively evaluating the effectiveness of endoscopic plication and laparoscopic fundoplication in terms of quality of life and symptom control. Between October 2006 and April 2010, 60 patients with documented GERD were randomly assigned to undergo either endoscopic plication or laparoscopic fundoplication. Quality-of-life scores and symptom grading were recorded before treatment and at 3- and 12-month follow-up. Outcomes were compared with the statistical significance set at a p value of 0.05. Twenty-nine patients from the endoscopic group and 27 patients from the operative group were available at follow-up. Quality-of-life scores showed a substantial and similar increase for both groups after treatment. Symptoms of heartburn (p < 0.02), regurgitation (p < 0.004), and asthma (p = 0.03) were significantly improved in the endoscopic group, whereas laparoscopic fundoplication was more effective in controlling symptoms of heartburn (p < 0.01) and regurgitation (p < 0.05) compared to the endoscopic procedure. Endoscopic plication and laparoscopic fundoplication resulted in significant symptom improvement with similar quality-of-life scores in a selected patient population with GERD, whereas operative treatment was more effective in the relief of heartburn and regurgitation at the expense of higher short-term dysphagia rates.

The esophagogastric junction.

The following discussion of the esophagogastric junctions includes commentaries on the three component structures of the sphincteric segment between the stomach and the esophagus; the pressure contributions from the three sphincteric components in normal subjects and in gastroesophageal reflux (GERD) patients; the mechanism of action of endoscopic plication to determine the underlying pathophysiology of GERD; and in vitro muscle strip studies of defects within the gastroesophageal sphincteric segment potentially leading to GERD.

Serious complication following use of StomaphyX

ular surgical procedure to treat morbid obesity [1]. StomaphyX (endoGastric Solutions Inc., Redmond, Washington, USA) is designed for incisionless transoral endoscopic plication and revision of the gastric pouch (EPRGP) in case of pouch dilation with weight gain [2,3]. Nonresorbable polypropylene fasteners create fullthickness plications of the pouch wall, reducing its volume. StomaphyX was cleared by the Food and Drug Administration (FDA) in April 2007 [4] and clinical results are becoming available, with only 3% early complications [5]. We present the case of a 38-year-old woman who underwent StomaphyX EPRGP in 2007, after RYGB in 2000. The procedure was carried out in a peripheral hospital by a surgeon and was not planned within the regulations governing ongoing clinical trials. After 3 days, the patient was referred to our hospital with fever and thoracic pain. Thoracic X-ray showed left lung empyema (● Fig. 1). Antibiotics were started and she underwent two thoracic surgical procedures to drain the left hemithorax and to remove the pleural membranes (● Fig. 2). Upper gastrointestinal endoscopy showed three StomaphyX fasteners through the distal oesophageal wall and a dilated gastric pouch with another three fasteners around the gastrojejunostomy (● Fig. 3). Because of persistent empyema, a third draining thoracotomy was carried out 14 days later, which revealed adhesions at the distal esophagus. Streptococcus viridans and non-aureus Staphylococcus were cultured and antibiotics started. After a 28-day stay in the hospital, the patient was fit enough to be discharged. At present, 4 years after the complicated StomaphyX procedure, the patient is still under treatment for postoperative neuralgic pain of the left hemithorax. She was not covered by a clinical trial insurance. This case report illustrates the risk of serious complications of StomaphyX and the ethical implications of using new devices outside the control of regulated clinical trials.

Early Results of Trans-Oral Endoscopic Plication and Revision of the Gastric Pouch and Stoma following Roux-en-Y Gastric Bypass Surgery

Early Results of Trans-Oral Endoscopic Plication and Revision of the Gastric Pouch and Stoma following Roux-en-Y Gastric Bypass Surgery

Gastric Plication Can Reduce Slippage Rate After Laparoscopic Gastric Banding

Laparoscopic insertion of a gastric band for weight reduction is increasingly performed in obese and morbidly obese patients. Complication rates after gastric band insertion are reduced by using certain techniques. This was a prospective study of all patients who underwent laparoscopic adjustable gastric band (LAGB) insertion at our unit. This procedure is performed through the classical 4-port technique and the use of a liver retractor. The pars flaccida method is performed in all patients, and the gold finger, a malleable instrument, is used to guide the band through the retroesophageal window in patients with difficult anatomy. Band slippage is avoided by using 2 types of gastric plication, depending on the anatomical characteristics of the stomach. Outcomes and morbidity are recorded, and patients are followed up in outpatient clinics. Laparoscopic adjustable gastric band (LAGB) insertion was performed in 464 patients. A single consultant surgeon performed all procedures over a 2-year period. From August 2005 through August 2007, 380 (81.89%) women and 84 (18.10%) men were included in this study. The mean age was 41 years (range, 21 to 62). The mean body mass index was 43 (range, 35 to 62). Morbidity included dysphagia, epigastric pain, port displacement, port infection, erosion, and acute respiratory distress. Only one (0.21%) case of band slippage was reported. The mean follow-up was 26 months (range, 18 to 42). Laparoscopic gastric plication adds greater security and provides optimum gastric band placement. It is an effective method to reduce slippage after gastric band insertion.

The Endoscopic Plicator Procedure for GERD Using Two Full-Thickness Plications

Purpose: The Plicator® (NDO Surgical, Mansfield MA) endoscopically delivers full-thickness pledgeted sutures to restructure the gastroesophageal junction and the anti-reflux barrier. To date, all Plicator studies have involved the placement of a single, full-thickness suture at the gastro-esophageal junction. The purpose of this pilot study was to evaluate the safety and effectiveness of placing two pledgeted sutures in the anterior gastric cardia. Methods: Patients with symptomatic GERD requiring maintenance proton pump inhibitor therapy were entered in an open-label, prospective, single-center pilot study. Patients with hiatal hernias > 3 cm, grade III and IV esophagitis, and Barrett's esophagus were excluded. All patients received two full-thickness Plicator sutures in the anterior gastric cardia, serially placed within 1 cm of the GEJ. The following were assessed at baseline and 18-months post-treatment: GERD-HRQL, VAS and medication use. The primary study endpoint was ≥50% improvement in GERD-HRQL score. Results: Thirty-seven patients underwent endoscopic full-thickness plication using two sutures. At 18-months post-treatment, the proportion of patients achieving ≥50% improvement in GERD-HRQL score was 57%. Median GERD-HRQL scores improved 61% compared to baseline off-meds scores (12.5 vs. 25.9, P < 0.001) and were superior when compared to patients' baseline on-meds GERD-HRQL scores (12.5 vs.15.6, P= 0.023). Heartburn symptoms measured by VAS showed a median improvement of 77% versus off-med baseline (P < 0.001). Complete PPI cessation was achieved in 35% of patients, with an additional 39% of patients able to reduce their PPI dose by at least half. All procedure-related adverse events occurred acutely, as previously reported, and no new adverse events were observed during extended follow-up. Conclusion: Endoscopic full-thickness plication using two sutures showed in 57% of patients an improvement in GERD-HRQL ≥50% at 18 months. Median GERD-HRQL scores improved 61% and heartburn symptoms showed a median improvement of 77%. Complete PPI cessation was achieved in 35% of patients. No new adverse events were observed during the 18 month follow-up.

Evaluation of Endoscopic Full-Thickness Plication on Anti-Reflux Valve Competency

We sought to investigate the efficacy of endoscopically created, full-thickness plications on the competency of the anti-reflux barrier when placed at different positions on the stomach adjacent to the gastroesophageal junction. Explanted human cadaver stomachs and esophagi were used. An endoscopic plication system (Plicator, NDO Surgical, Mansfield, Massachusetts) was then fitted over a pediatric gastroscope and passed through the esophagus into the stomach. A full-thickness plication implant was then deployed at 1 of 3 positions (fundus, anterior, and between the anterior and the lesser curvature) on the explanted stomach within 1 cm of the gastroesophageal junction. Intragastric pressure was measured before and after plication at the time of visible reflux from the esophagus (reflux threshold) using a water-perfused manometer. Five explanted stomachs were used. The mean reflux threshold before plication (baseline) was 1.7 mm Hg. A single plication at each position resulted universally in a significantly increased reflux threshold over the baseline value (p < 0.006). The greatest reflux threshold was observed when plication was performed on the anterior wall of the stomach, although this reflux pressure did not achieve statistical significance over the other 2 positions. A second plication performed adjacent to the initial plication at the fundus (n = 2) and anterior (n = 2) positions did increase reflux threshold; however, this increase also failed to achieve statistical significance. These results suggest that an endoscopic, full-thickness plication system can inhibit gastroesophageal reflux effectively in an explanted stomach model. Although anterior plication resulted in the greatest intragastric pressure at reflux, it was not significantly different from intragastric pressure recorded at the other plication positions. A second plication adjacent to the first showed incremental effect, but larger studies are warranted to understand its clinical significance.

Endoscopic Plication for Treatment of GERD

Many patients with gastroesophageal reflux disease (GERD) would like to discontinue their medications but are unwilling to undergo surgery. Endoscopic

Endoscopic Plication for GERD Treatment: First Results of the Multi-Center Study with Serial Full-Thickness Plications Using the NDO Surgical Plicator™

Endoscopic Plication for GERD Treatment: First Results of the Multi-Center Study with Serial Full-Thickness Plications Using the NDO Surgical Plicator™

Endoscopic plication partially restores a missing tonic pressure component to the LES and the stiffness of relaxed esophageal muscle during tLESR in patients with GERD

Temple University Medical Center, United States Special Issue of the 8th World Congress of OESO Avignon, September 3–6, 2006 Oral, Video and Poster Sessions

The His-Wiz Antireflux Procedure Results in Symptomatic and pH Improvement At 1 Year of Follow-Up

Introduction: We have previously described the development of the His-Wiz as a novel endoscopic device that allows for infrasphincteric plication resulting in accentuation of the gastroesophageal barrier. The device, which is overtube based, is simple and rapid and allows for the placement of full-thickness suturing and automatic cutting ability in a one-step procedure. We now report the results of a one year follow-up of 7 patients treated with a 2-plication approach. Methods: A prospective pilot study was performed in 7 patients with chronic GERD requiring maintenance antisecretory therapy. Two plications were performed on the anterior and posterior walls just below the gastroesophageal junction. Patients were followed clinically with periodic monitoring of heartburn score (HBS), 24 hr pH-monitoring and use of acid suppressive therapy up to 1 year after treatment. Results: The procedure was done using IV propofol anesthesia in the outpatient setting and took approximately 5-10 minutes to complete. All patients improved clinically with an improvement in heartburn scores that was sustained up to 1 year along with significant improvements in pH monitoring (which normalized at 6 months) although a trend towards worsening of acid reflux was seen at 1 year (TABLE). At the end of 1 year, 4/7 patients remained off all antisecretory medication, with the rest requiring occasional (<2 pills/week)therapy with the same. Most side effects were minor and transient (e.g. chest pain); however, one patient experienced significant bleeding after the second plication requiring endoscopic therapy. Conclusions: Endoscopic plication for GERD using the His-Wiz device appears to be simple, feasible and effective in both improving symptoms and esophageal pH exposure for up to 1 year at least. This is one of the few endoscopic treatments that has a robust effect on acid reflux in addition to symptoms. Further follow-up is required to establish more firm conclusions about the safety and efficacy of this new procedure. Tabled 1 Baseline 3 month 6 month 1 year HB Score 21.9 ± 0.9 4.6 ± 2.2 ∗ P < 0.001; 5.0 ± 2.1 ∗ P < 0.001; 6.3 ± 2.6 ∗ P < 0.001; % pH <4 10.9 ± 1.7 4.2 ± 0.9 P < or = 0.01 (compared with baseline) 3.0 ± 0.8 P < or = 0.01 (compared with baseline) 6.6 ± 2.7 ∗ P < 0.001; ∗∗ P < or = 0.01 (compared with baseline) Open table in a new tab

Endoscopically Placed Titanium Plicator for GERD: Pivotal Phase -- Preliminary 6-Month Results

Background: Endoscopic treatment of GERD has emerged as an alternative to medicine & surgery. The Syntheon Anti-Reflux Device (ARD) consists of a titanium implant that is used to create a full-thickness gastric plication in the cardia along the anterior lesser curve. It allows the use of a standard gastroscope without an overtube and is easily removable in the first 48 hours post placement. Aim: Determine safety and efficacy of ARD in treatment of GERD. Methods: Seventy (70) subjects with symptomatic chronic GERD, abnormal esophageal pH studies, normal esophageal motility, dependent on and responsive to daily use of antisecretory therapy were treated. Exclusion criteria were hiatal hernia >2 cm, BMI >35, LA grade “C” or “D” esophagitis, Barrett's and non-responsiveness to medication. Baseline and follow-up testing at 1, 3 & 6 months included medication history, 48 hr pH study, esophageal manometry, EGD, GSRS, GERD-HRQL, SF-36. Results: 40 males & 30 females (mean age 50, mean BMI 28.5) underwent endoscopic plication. No retreatments were performed. In a group of 57 patients that have completed the six month follow up the mean GERD-HRQL improved 69% and the median improvement was 75%. The majority of patients (79%) showed a 50% or better improvement in GERD-HRQL. Ambulatory pH monitoring (48 hr) with pH <4 showed a median decrease of 27% (50 patients) with 26% (13/50) of the patients experiencing a normalization of pH. There was an increase in median LES length of 29%. At six months 33 of 52 (63%) were off all antisecretory therapy. The mean ARD procedure time was 16 minutes. All implants were in place at follow-up endoscopy. The most common adverse event was epigastric/referred chest pain (31%). A single gastric perforation occurred during closure of the device in a patient with a prior history of complicated peritoneal infection. Following surgical intervention, the patient had an uneventful recovery. Conclusions: The ARD device for full-thickness plication of the gastric cardia proved efficacious and time efficient with an acceptable safety profile for well selected patients. The ARD reduced symptoms, medication use, and acid exposure in GERD patients studied.

Endoscopic plication of massively bleeding peptic ulcer by using the Eagle Claw VII device: a feasibility study in a porcine model

We examined the efficacy of endoscopic plication when using Eagle Claw VII in a porcine bleeding ulcer model. ANIMAL MODEL PREPARATION: The right gastroepiploic artery (diameter 1.5-2 mm) was isolated and was tunneled to small gastrotomies at either the lesser or greater curvature of the stomach. We applied the Eagle Claw VII to achieve hemostasis. The survival of the pigs after endoscopic plication for hemostasis, time to achieve hemostasis with Eagle Claw VII, recurrent bleeding, number of successful plication, and number of suture remained. Endoscopic plication was performed on bleeding gastric ulcers in 6 pigs. The time to achieve hemostasis was 6 minutes 56 seconds +/- 3 minutes 50 seconds. There was no complication. A total of 14 plications were performed. All animals survived for 1 week without recurrent bleeding. At the postmortem, 10 of the plication sutures remained. Our model cannot simulate the chronicity of peptic ulcer. In this porcine model, the Eagle Claw VII effectively stopped bleeding from arteries 2 mm in size.

Comparison of Transesophageal Endoscopic Plication (TEP) with Laparoscopic Nissen Fundoplication (LNF) in the Treatment of Uncomplicated Reflux Disease

Transesophageal endoscopic plication (TEP) is a novel endotherapeutic approach in the management of gastroesophageal reflux disease (GERD). This non-randomized prospective study compares TEP with laparoscopic Nissen fundoplication (LNF). Twenty-four consecutive patients treated with LNF, and 27 managed by TEP were studied. Symptom severity scores, endoscopy, 24 h esophageal pH and esophageal manometry and quality-of-life assessments were obtained pre- and posttreatment. In the LNF group the mean age was 36 yr (17-68) compared with 39 yr (22-62) in the TEP group. Symptom scoring, acid regurgitation score, reduction in the requirements of proton pump inhibitors (PPIs), and quality of life remained significantly improved in both groups at a median of 1 yr [10-18 months] follow-up post procedure. However, the improvement was significantly better in symptom score (p= 0.0383) and the control of acid reflux in the LNF group (p= 0.0007). Post-procedure dysphagia was more common in the LNF group. Both techniques improved symptom score, acid regurgitation, quality of life, and reduced the requirements for PPIs. The control of heartburn and acid reflux was better for LNF. TEP, like LNF, is a safe and effective method of management of symptomatic GERD but further developments are necessary to ensure control of esophageal acid reflux.

Laparoscopic Nissen fundoplication after biopolymer injection: a case report

Both medical and surgical therapies can be highly successful in the management of the symptoms and signs of GERD. During the past few years, new endoscopic techniques for GERD treatment have been described and approved by the Food and Drug Administration: endoscopic plication, radiofrequency application, and biopolymer injection into the lower esophageal sphincter (LES). Greater experience is needed before these new techniques can be considered as alternatives to proton pump inhibitor (PPI) therapy.

Endoscopic Gastric Plication for the Treatment of GERD

Endoscopic Gastric Plication for the Treatment of GERD