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1.

Purpose

The three major techniques for a gastrostomy in children are open gastrostomy (OG), percutaneous endoscopic gastrostomy (PEG) and laparoscopic-assisted gastrostomy. Here, we have evaluated the outcome after OG and PEG in 69 children operated in Kuopio University Hospital.

Methods

The medical records of 69 consecutive children who had either PEG (n?=?56) or OG (n?=?13) over an 18-year period (1990–2008) were reviewed.

Results

There was no difference between the PEG- and OG-groups in the patients’ characteristics, indications for tube placement and hospital stay. The mean procedure time was 43 min shorter in the PEG-group (28?±?38 min) than in the OG-group (71?±?58 min) (P?=?0.003). Four children (8%) in the PEG-group and one (8%) in the OG-group required later surgical interventions related to gastrostomy. Severe gastro-oesophageal reflux (GER) necessitating fundoplication was detected in 15 children (27%) in the PEG-group and in 7 children (54%) in the OG-group (P?=?0.06).

Conclusion

The results of this study indicated a higher incidence for severe GER leading to fundoplication in children with OG, while no difference with complications and clinical outcome between the two techniques, OG and PEG, were observed.  相似文献   

2.

Objective

This study was designed to describe and analyze the outcomes after laparoscopic reversal to normal anatomy (NA) with or without concomitant “sleeve gastrectomy” (SG), after Roux-en-Y gastric bypass (RYGB). Reversal has been proposed as corrective strategy after RYGB.

Methods

We propose a retrospective analysis of a prospectively kept database.

Results

From January 2005 to October 2012, 20 female patients underwent laparoscopic reversal after RYGB for one or more of the following conditions: hypoglycaemic syndrome (nine patients), weight regain (six patients), severe dumping (six patients), and cachexia (two patients). Preoperative BMI was 28.0 (19.2–40.3) kg/m². Reversal was performed to NA in ten patients and included a SG procedure in another ten. Postoperative complications included one bleeding and three leaks (15 %; all in SG patients). Mean hospital stay was 7 days. Mortality was 0. With a mean follow-up of 11.5 months, all but one patient recovered from their initial condition. However, three developed severe gastroesophageal reflux disease (GERD) symptoms and three had chronic diarrhoea.

Conclusions

Outcomes of laparoscopic reversal of RYGB are good, but complications may occur when SG is added. The surgical alterations caused by the reversal may explain the GERD or diarrhoea experienced by some patients.  相似文献   

3.

Background

Endoscopic grading of the gastroesophageal flap valve (GEFV) is simple, reproducible, and suggested to be a good predictor of reflux activity. This study aimed to investigate the potential correlation between grading of the GEFV and quality of life (QoL), gastroesophageal reflux disease (GERD) symptoms, esophageal manometry, multichannel intraluminal impedance monitoring (MII) data, and size of the hiatal defect.

Methods

The study included 43 patients with documented chronic GERD who underwent upper gastrointestinal endoscopy, esophageal manometry, and ambulatory MII monitoring before laparoscopic fundoplication. The GEFV was graded 1–4 using Hill’s classification. QoL was evaluated using the Gastrointestinal Quality-of-Life Index (GIQLI), and gastrointestinal symptoms were documented using a standardized questionnaire. The size of the esophageal hiatus was measured during surgery by calculating the hiatal surface area (HSA). Analysis of the correlation between QoL, GERD symptoms, esophageal manometry, MII data, HSA size, and GEFV grading was performed. Statistical significance was set at a p value of 0.05.

Results

A significant positive correlation was found between increased GEFV grade and DeMeester score, total number of acid reflux events, number of reflux events in the supine position, and number of reflux events in the upright position. Additionally, a significant positive correlation was found between HSA size and GEFV grading. No significant influence from intensity of GERD symptoms, QoL, and the GEFV grading was found. The mean LES pressures were reduced with increased GEFV grade, but not significantly.

Conclusions

The GEFV plays a major role in the pathophysiology of GERD. The results underscore the importance of reconstructing a valve in patients with GERD and an altered geometry of the gastroesophageal junction when they receive a laparoscopic or endoscopic intervention.  相似文献   

4.

Background

Sleeve gastrectomy (SG) is currently gaining popularity due to an excellent efficacy combined to minimal anatomic changes. However, some concerns have been raised on increased risk of postoperative gastroesophageal reflux disease (GERD) due to gastric fundus removal, section of the sling muscular fibers of gastroesophageal junction, reduced antral pump function, and gastric volume. We undertook the current study to evaluate by means of high-resolution impedance manometry (HRiM) and combined 24-h pH and multichannel intraluminal impedance (MII-pH) the impact of SG on esophageal physiology.

Methods

In this study, 25 consecutive patients had HRiM and MII-pH before and after laparoscopic SG. The following parameters were calculated at HRiM: lower esophageal sphincter (LES) pressure and relaxation, peristalsis, number of complete esophageal bolus transit, and mean total bolus transit time. The acid and non-acid GER episodes were assessed by MII-pH with the patient in both upright and recumbent positions.

Results

At a median follow-up of 13 months, HRiM showed an unchanged LES function, increased ineffective peristalsis, and incomplete bolus transit. MII-pH showed an increase of both acid exposure of the esophagus and number of non-acid reflux events in postprandial periods.

Conclusions

Laparoscopic SG is an effective restrictive procedure that creates delayed esophageal emptying without impairing LES function. A correctly fashioned sleeve does not induce de novo GERD. Retrograde movements and increased acid exposure are probably due to stasis and postprandial regurgitation.  相似文献   

5.
Background/Purpose: Percutaneous endoscopic gastrostomy (PEG) is of great benefit to a defined population of children, but gastrostomy has been implicated in causation or exacerbation of gastroesophageal reflux (GER). The aim of this study was to quantitatively and qualitatively analyze the effect of PEG on GER. Methods and Material: Sixty-four children mean age 6.7 [plusmn] 4.2 years, most of whom were impaired neurologically were evaluated for GER after PEG between 1998 and 2000. Twenty-four[ndash ]hour pH monitoring was used for quantitative assessment. Qualitative analysis was by interview to record the following: vomiting, choking, chest infection, and weight gain. Results: Twenty-four[ndash ]hour pH monitoring was performed 9.4 [plusmn] 1.2 weeks after PEG. Patients underwent follow-up for 18 [plusmn] 6 months. Seventy-two percent who did not have reflux before PEG remained reflux free. Fourteen percent who had GER before PEG continued to have reflux (P [lt ] .05). Only 5% of patients without GER before PEG had reflux afterward, and 3% of patients with preexisting GER deteriorated (P [gt ] .05). Six percent of patients with preexisting GER improved post-PEG. Of the 14 patients (22%) who had or continued to have reflux after PEG, 11 of 14 (79%) underwent antireflux surgery, and 21% were managed successfully by intensive medical treatment and change of feeding regimen. Only 6% experienced difficulties and complications with the device. Forty-eight percent of patients did not vomit pre- or postoperation. In 16%, vomiting improved post-PEG, whereas 14% experienced minor deterioration (1 to 2 vomits per month). Major deterioration was experienced by 22%. Weight gain occurred in 77%, and in 23% there was no loss of weight. There was an overall improvement in quality of life in 88% after PEG. Overall improvement in quality of life post-PEG, post[ndash ]antireflux surgery and post[ndash ]intensive medical management for pathologic GER was 94%. Conclusions: (1) PEG did not precipitate or exacerbate GER quantitatively or qualitatively in the majority of children. (2) A normal 24-hour pH study predicted a favourable outcome after PEG. (3) An abnormal preoperation pH study predicted persistence or worsening reflux after PEG, but not all of these patients required an antireflux procedure. (4) GER is not a contraindication to PEG, the overall benefits of which outweigh the risks.  相似文献   

6.

Background

The topic of “when and what” for gastroesophageal reflux disease (GERD) procedures centers on the correct indications for antireflux surgery gleaned from a thorough preoperative evaluation (the “when”) and on the right antireflux operation to perform once the ideal candidate is identified (the “what”).

Aims

The goals of this evidence-based review are the following: (1) to identify the key indications for surgery and predictors of good outcomes in the initial evaluation of patients with symptoms of GERD; (2) to describe the operations for GERD in the armamentarium of the general surgeon and their indications, as well as the technical elements of the operation; and (3) to describe the optimal surgical treatment of GERD and obesity when the two diseases coexist.  相似文献   

7.

Introduction

The threshold for pathologic proximal acid reflux is a controversial topic. Most values previously published are based on absolute numbers. We hypothesized that a relative value representing the quantitative relation between the amount of acid reflux that reaches proximal levels and the amount of distal reflux would be a more adequate parameter for defining pathologic proximal reflux.

Methods

We studied 20 healthy volunteers (median age 30 years, 70 % women) without gastroesophageal reflux disease (GERD); 50 patients (median age 51 years, 60 % women) with esophageal symptoms of GERD (heartburn, regurgitation); and 50 patients (median age 49 years, 60 % women) with extra-esophageal symptoms of GERD. All individuals underwent manometry and dual-probe pH monitoring. GERD was defined as a DeMeester score >14.7. The proximal/distal reflux ratio was calculated for all six parameters that constitute the DeMeester score.

Results

Absolute numbers for proximal reflux were not different for the three groups except for the number of episodes of reflux, which was higher for patients with GERD and esophageal symptoms than for patients with GERD and extra-esophageal symptoms (p = 0.007). The number of episodes of distal reflux reaching proximal levels was significantly higher in volunteers than in all patients with GERD and significantly higher in patients with GERD and esophageal symptoms than in those with extra-esophageal symptoms.

Conclusions

Our results suggest that the proximal/distal reflux ratio is not a good normative value for defining proximal reflux.  相似文献   

8.

Background

Transoral incisionless fundoplication (TIF), a novel endoscopic procedure for treating gastroesophageal reflux disease (GERD), currently is under evaluation. In case of treatment failure, subsequent revisional laparoscopic antireflux surgery (rLARS) may be required. This study aimed to evaluate the feasibility, safety, and outcomes of revisional antireflux surgery after previous endoscopic fundoplication.

Methods

Chronic GERD patients who underwent rLARS after a previous TIF procedure were included in the study. Pre- and postoperative assessment included GERD-related quality-of-life scores, proton pump inhibitor (PPI) usage, 24-h pH-metry, upper gastrointestinal endoscopy, and registration of adverse events.

Results

Revisional laparoscopic Nissen fundoplication was feasible for all 15 patients included in the study without conversions to open surgery. Acid exposure of the distal esophagus improved significantly after rLARS, and esophagitis, PPI usage, and hiatal hernia decreased. Quality of life did not improve significantly after rLARS, and 33 % of the patients experienced dysphagia.

Conclusion

Revisional laparoscopic Nissen fundoplication was feasible and safe after unsuccessful endoscopic fundoplication, resulting in objective reflux control at the cost of a relatively high rate of dysphagia.  相似文献   

9.

Introduction

Management of gastroesophageal reflux disease (GERD) is based on the concept that gastric contents, principally acid and pepsin, are responsible for symptoms of reflux and esophageal injury. Pharmacologic treatment is based on the principle that controlling intragastric pH will affect esophageal healing and subsequently symptom relief.

Results and Discussion

Control of pH can be accomplished with antisecretory agents, principally proton pump inhibitors (PPIs). The majority of patients respond to a single daily dose of a PPI; however, some will require higher doses, and a small percentage are “refractory” to twice daily dosing of these drugs. The success of these agents, and in fact the reasons for “failure,” is elucidated by understanding the mechanism of action of PPIs and the effect of dose timing and meals on their efficacy.

Conclusion

Awareness of new concerns regarding potential side effects of PPIs when used long-term require careful thought as GERD is a chronic disease with most needing some form of medical treatment over time. This article reviews the pharmacologic properties of PPIs and the impact on the treatment of GERD.
  相似文献   

10.

Background

Many surgeons feel comfortable performing antireflux surgery (ARS) on the basis of symptomatic evaluation, endoscopy, and barium esophagography. While esophageal manometry is often obtained to assess esophageal peristalsis, pH monitoring is rarely considered necessary to confirm the diagnosis of gastroesophageal reflux disease (GERD).

Aims

The aim of this study was to analyze the sensitivity and specificity of symptoms, endoscopy, barium esophagography, and manometry as compared to pH monitoring in the preoperative evaluation of patients for ARS.

Patients and Methods

One hundred and thirty-eight patients were referred for ARS with a diagnosis of GERD based on symptoms, endoscopy, and/or barium esophagography. Barium esophagography, esophageal manometry, and ambulatory 24-h pH monitoring were performed preoperatively in every patient.

Results

Four patients were found to have achalasia and were excluded from the analysis. Based on the presence or absence of gastroesophageal reflux on pH monitoring, the remaining 134 patients were divided into two groups: GERD+ (n?=?78, 58 %) and GERD? (n?=?56, 42 %). The groups were compared with respect to the incidence of symptoms, presence of reflux and hiatal hernia on esophagogram, endoscopic findings, and esophageal motility. There was no difference in the incidence of symptoms between the two groups. Within the GERD+ group, 37 patients (47 %) had reflux at the esophagogram and 41 (53 %) had no reflux. Among the GERD? patients, 17 (30 %) had reflux and 39 (70 %) had no reflux. A hiatal hernia was present in 40 and 32 % of patients, respectively. Esophagitis was found at endoscopy in 16 % of GERD+ patients and in 20 % of GERD? patients. Esophageal manometry showed no difference in the pressure of the lower esophageal sphincter or quality of peristalsis between the two groups.

Conclusions

The results of this study showed that (a) symptoms were unreliable in diagnosing GERD, (b) the presence of reflux or hiatal hernia on esophagogram did not correlate with reflux on pH monitoring, (c) esophagitis on endoscopy had low sensitivity and specificity, and (d) manometry was mostly useful for positioning the pH probe and rule out achalasia. Ambulatory 24-h pH monitoring should be routinely performed in the preoperative work-up of patients suspected of having GERD in order to avoid unnecessary ARS.  相似文献   

11.

Background

Enteral nutrition (EN) is a widely used, standard-of-care technique for nutrition support in critically ill and trauma patients.

Objective

To review the current techniques of gastrointestinal tract access for EN.

Methods

For this traditional narrative review, we accessed English-language articles and abstracts published from January 1988 through October 2012, using three research engines (MEDLINE, Scopus, and EMBASE) and the following key terms: “enteral nutrition,” “critically ill,” and “gut access.” We excluded outdated abstracts.

Results

For our nearly 25-year search period, 44 articles matched all three terms. The most common gut access techniques included nasoenteric tube placement (nasogastric, nasoduodenal, or nasojejunal), as well as a percutaneous endoscopic gastrostomy (PEG). Other open or laparoscopic techniques, such as a jejunostomy or a gastrojejunostomy, were also used. Early EN continues to be preferred whenever feasible. In addition, evidence is mounting that EN during the early phase of critical illness or trauma trophic feeding has an outcome comparable to that of full-strength formulas. Most patients tolerate EN through the stomach, so postpyloric tube feeding is not needed initially.

Conclusion

In critically ill and trauma patients, early EN through the stomach should be instituted whenever feasible. Other approaches can be used according to patient needs, available expertise, and institutional guidelines. More research is needed in order to ensure the safe use of surgical tubes in the open abdomen.  相似文献   

12.

Background

Laparoscopic sleeve gastrectomy (SG) is a relatively new procedure that is gaining wide acceptance and represents an innovative new approach to the surgical management of morbid obesity. Our purpose is to evaluate the SG as a surgical bariatric procedure.

Methods

We conducted a literature review on “PubMed” based on all publications related to SG since 2000 to July 30, 2014.

Results

The complication rate after SG varies in the literature, ranging from 0 to 29 %. The most feared complication after SG is leakage on the staple line, occurring in 0–7 % of cases. The mortality rate reported varies between 0 and 3.3 %. No consensus has developed on the types of stapling used or the methods of strengthening the staple line. SG may aggravate and be responsible for gastroesophageal reflux disease (GERD). SG improves comorbidities in more than 50 % after 5 years.

Conclusions

SG can be proposed as a surgical technique at first intension in patients not having GERD.  相似文献   

13.

Background/Purpose

The percutaneous endoscopic gastrostomy (PEG) is contested on the ground that it could cause gastroesophageal reflux (GER). The authors studied the complications of PEG to ponder the validity of this contraindication.

Methods

The authors followed up with a group of 81 patients subjected to PEG to assess their complications, GER in particular.

Results

In half of the patients, PEG was performed under deep sedation in the intensive care unit and the other half under general anesthesia. The procedure lasted about 12 minutes in both subgroups. Early complications were not observed. Late complications relating to the care of the tube were similar to those reported for other techniques. GER appeared in 8%, but surgical treatment was unnecessary, whereas in patients that presented GER before surgery, it subsided in 38%. A colocutaneous fistula observed in one patient was a consequence of previous interventions.

Conclusions

PEG is minimally invasive, general anesthesia may be avoided, the procedure is rapid, major complications are conspicuously absent, and the incidence of GER is smaller than that associated with alternative techniques. In addition, the cost is low. The authors consider PEG the technique of choice because it has important advantages compared with open or laparoscopic techniques.  相似文献   

14.

Purpose

Percutaneous endoscopic gastrostomy (PEG) tube placement is a common procedure performed for children with oral aspiration and failure to thrive. The concurrent presence of gastroesophageal reflux (GER) may be difficult to diagnose in these children and may dictate the need for an antireflux procedure. The purpose of this study was to review our preoperative evaluation of children undergoing PEG placement to better elucidate preoperative factors that may require eventual fundoplication.

Methods

A retrospective review at a tertiary care, children's hospital between May 2002 and August 2007 was performed of patients undergoing PEG placement. Patients were identified through database search by operative procedure codes. Patient groups were defined as those undergoing PEG alone (group 1) and those requiring fundoplication after prior PEG (group 2). Comparison of patient demographics and radiologic qualitative results of GER was analyzed using χ2 analysis, with significance determined at P < .05.

Results

A total of 863 patients underwent PEG placement over this 64-month period. A sampled cohort of patients undergoing PEG over a year comprised group 1. Forty-four patients (5.1%) underwent Nissen fundoplication after prior PEG placement (group 2). Patient demographics were similar between the groups. Comparison of comorbid conditions and qualitative indicators of GER between the groups showed only cerebral palsy had a significantly higher associated risk of GER that required antireflux surgery. Preoperative clinical assessment had a 95% positive predictive value in identifying children who required only PEG.

Conclusions

Despite the high predictive value of individualized clinical assessment in the ultimate decision for gastrostomy without need of fundoplication, further studies are needed to determine whether children with conditions such as cerebral palsy may require a concurrent antireflux surgery at the time of gastrostomy.  相似文献   

15.

Aim — Background

Barrett’s oesophagus is a condition caused by acid reflux from the stomach to the oesophagus for a prolonged period of time. Patients with Barrett’s oesophagus are at significant risk of developing oesophageal adenocarcinoma. This risk decreases with antireflux surgery. Treatment of gastroesophageal reflux disease (GERD) by Nissen fundoplication surgery has a success rate of 85–90%. The aim of this study is to highlight the significance of oesophageal pH measurement as part of the postoperative follow-up of patients diagnosed with Barrett’s oesophagus who undergo the Nissen fundoplication procedure.

Patients and methods

Between 2010 and 2012, eleven patients with Barrett’s oesophagus underwent Nissen fundoplication in our clinic, followed by 48h wireless oesophageal pH-metry monitoring.

Results

All patients reported relief of GERD typical symptoms. Mean DeMeester score of 1.5 was measured at the fifth postoperative month.

Conclusion

Prevention of oesophageal adenocarcinoma in patients with Barrett’s oesophagus is crucial. These patients are exposed to a great risk of adenocarcinoma development, not only owing to the potential progression of Barrett’s oesophagus to adenocarcinoma, but also because of the decreased capacity to experience typical GERD symptoms. Given the possibility of antireflux surgery failure and the fact that symptoms may be an unreliable indicator of GERD presence, postoperative oesophageal pHmetry is mandatory.  相似文献   

16.

Background

The optimal treatment strategy of esophageal high-grade dysplasia (HGD) and superficial adenocarcinoma remains controversial.

Methods

Here, we describe endoscopic, circumferential mucosal-submucosal en-bloc resection of the entire abnormal esophageal epithelium with extracellular matrix (ECM) placement to regenerate neoepithelium and minimize stricture. That procedure was then followed by a laparoscopic fundoplication as a novel esophageal-preserving approach to treat HGD and superficial adenocarcinoma in the face of chronic gastroesophageal reflux disease (GERD).

Conclusions

This approach could be an ideal option as an alternative to esophagectomy in selected patients.  相似文献   

17.

Background

Intragastric balloons (BIB) are routinely used for weight reduction. They should be placed to the gastric fundus, as this place is believed more effective for achievement of satiety and thus weight reduction. The aim of the present study was to evaluate whether the balloon position may affect 6-month weight loss as well as first-month side-effects, i.e. nausea, vomiting, and gastroesophageal reflux.

Methods

From a total of 158 BIB-treated obese individuals, 105 females were found eligible, since the balloon in the stomach was found upon removal in the same position (fundus or antrum) placed at the time of insertion. These subjects were divided into fundus and antral groups. Data related to obesity were recorded on day 0 and upon BIB removal, 6?months thereafter. Data related to transient side-effects (nausea, vomiting, gastroesophageal reflux) were recorded on days 0?C3, 7, and weekly thereafter, for 1?month.

Results

BIB placed in the antrum was found to have significantly better results on weight loss parameters, while nausea, vomiting (p?=?0.02) as well as gastroesophageal reflux still remained up to the fourth week in a relation to the fundus group. Similarly, the rate of gastric distension was found significantly increased (p?=?0.001) during the days 1?C3 in fundus group in relation to antrum, followed by a progressive decrease in both groups.

Conclusions

Intragastric balloon placed in the antrum lead to better results in weight reduction but to longer duration of tolerability-related side-effects, i.e., nausea, vomiting, and gastroesophageal reflux.  相似文献   

18.

Background

Proof of the relationship between gastroesophageal reflux disease (GERD) and respiratory symptoms remains a challenge. Our aim was to determine the association between reflux events and O2 desaturation in GERD patients with primary respiratory symptoms (RS) compared to those with primary esophageal symptoms (ES) using ambulatory monitoring systems.

Methods

One thousand eight hundred fifty-one reflux episodes were detected by multichannel intraluminal impedance (MII)–pH testing in 30 patients with symptoms of GERD (20 RS, ten ES.) All patients underwent simultaneous 24-h MII–pH and continuous O2 saturation monitoring via pulse oximetry. Reflux-associated desaturation events were determined by correlating synchronized 24-h esophageal pH and/or impedance and O2 desaturation.

Results

One thousand one hundred seventeen reflux events occurred in patients with RS and 734 in those with ES. Nearly 60% of these 1,851 reflux events were associated with O2 desaturation. Markedly more events were associated with O2 desaturation in patients with RS (74.5%, 832/1,117) than in patients with ES (30.4%, 223/734, p?<?0.0001). The difference in reflux desaturation association was more profound with proximal reflux—80.3% with RS vs. 29.4% with ES (p?<?0.0001).

Conclusions

A remarkably high prevalence of O2 desaturation associated with gastroesophageal reflux was noted in patients with RS. Given further study, simultaneous combined esophageal reflux and O2 saturation monitoring may prove a useful diagnostic tool in this difficult group of patients.  相似文献   

19.

Background/Purpose

Previously, we performed concomitant antireflux surgery in patients with abnormal pH study undergoing gastrostomy. This increased complications without always alleviating the troublesome symptom of vomiting. In contrast, vomiting with normal preoperative pH study generally disappeared after gastrostomy placement. Therefore, we changed policy to perform only gastrostomy, regardless of pH study results. Subsequent antireflux surgery is performed only as necessary. We report here our results.

Methods

We retrospectively reviewed patients undergoing gastrostomy from April 1997 to January 2004. For patients with abnormal preoperative pH studies, detailed data were recorded including medical history, indication for gastrostomy, operative technique, symptoms of gastroesophageal reflux (GER), and use of antireflux medication. Symptomatic GER postgastrostomy was managed pharmacotherapeutically. If this proved inadequate, patients underwent antireflux surgery.

Results

Twenty-eight patients with abnormal pregastrostomy pH study entered the study. Median age was 3 years and 2 months. Seventy-five percent were neurologically impaired. Indication for gastrostomy was inadequate oral nutrition in 26 of 28 patients. Only 3 of 28 patients were asymptomatic for GER. Of the 25 symptomatic patients 19 improved postgastrostomy (6 did not). Antireflux surgery ultimately proved indicated in 2 patients (7% [2/28]). The asymptomatic patients remained asymptomatic.

Conclusions

For patients with abnormal pH study presenting primarily for gastrostomy placement, concomitant antireflux surgery is not indicated.  相似文献   

20.

Background

The full-thickness Plicator® (Ethicon Endosurgery, Sommerville, NJ, USA) was developed for endoscopic treatment of gastroesophageal reflux disease (GERD). The goal is to restructure the antireflux barrier by delivering transmural pledgeted sutures through the gastric cardia. To date, studies using this device have involved the placement of a single suture to create the plication. The purpose of this study was to evaluate the 12-month safety and efficacy of this procedure using multiple implants to restructure the gastroesophageal (GE) junction.

Methods

A multicenter, prospective, open-label trial was conducted at four tertiary centers. Eligibility criteria included symptomatic GERD [GERD Health-Related Quality-of-Life (GERD-HRQL) questionnaire, off of medication], and pathologic reflux (abnormal 24-h pH) requiring daily proton pump inhibitor therapy. Patients with Barrett’s epithelium, esophageal dysmotility, hiatal hernia >3 cm, and esophagitis (grade III or greater) were excluded. All patients underwent endoscopic full-thickness plication with linear placement of at least two transmural pledgeted sutures in the anterior gastric cardia.

Results

Forty-one patients were treated. Twelve months post treatment, 74% of patients demonstrated improvement in GERD-HRQL scores by ≥50%, with mean decrease of 17.6 points compared with baseline (7.8 vs. 25.4, p < 0.001). Using an intention-to-treat model, 63% of patients had symptomatic improvements of ≥50%, with mean GERD-HRQL decrease of 15.0 (11.0 vs. 26.0, p < 0.001). The need for daily proton pump inhibitor (PPI) therapy was eliminated in 69% of patients at 12 months on a per-protocol basis, and 59% on an intention-to-treat basis. Adverse events included postprocedure abdominal pain (44%), shoulder pain (24%), and chest pain (17%). No long-term adverse events occurred.

Conclusions

Endoscopic full-thickness plication using multiple Plicator implants can be used safely and effectively to improve GERD symptoms and reduce medication use.  相似文献   

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