Endoluminal GERD treatments: critical appraisal of current literature with evidence-based medicine instruments

Background The literature of endoluminal treatment of gastroesophageal reflux disease (GERD) widely varies in the level of evidence presented for analysis. Therefore there is a need for a comprehensive evidence-based medicine (EBM) analysis of the current literature evidence of the three FDA-approved modalities used for endoluminal treatment of GERD. Search strategy In January 2007, the MEDLINE database was searched for randomized controlled trials (RCTs), and controlled clinical trials of currently available endoluminal treatment of GERD. Database searches combined the specific endoluminal device keywords with the condition-specific keyword (e.g., GERD). Data collection and analysis All relevant studies have been categorized according to the evidence they provide according to the guidelines for Levels of Evidence and Grades of Recommendation supplied by the Oxford Centre for Evidence-Based Medicine. Main results and Authors’ Conclusion Sixteen studies met the inclusion criteria, representing 787 patients. The methodological quality of most of the included studies was average; four studies were grade 1b (individual randomized trial), 10 were grade 2b (individual cohort study), and two were grade 3b (individual case-control study) There is grade 1b and 2b evidence demonstrating the EndoCinch plication is effective in reducing GERD symptoms at short-term follow up. However, in the majority of the studies analyzed, the procedure does not significantly reduce the acid exposure in the distal esophagus. The majority of the studies with long-term outcome showed disappointing outcomes, probably due to suture loss in the majority of patients. There is grade 1b and 2b evidence demonstrating that the Stretta procedure is effective in reducing GERD symptoms at short- and mid-term follow up. However, in the majority of the studies analyzed, the procedure did not reduce significantly the acid exposure in the distal esophagus. There is grade 1b and 2b evidence demonstrating that full-thickness plication is effective in reducing GERD symptoms, and acid exposure in the distal esophagus.     

Paraesophageal Hernia Repair With Partial Longitudinal Gastrectomy in Obese Patients

Background and Objectives:

Treatment of gastroesophageal reflux disease (GERD) with hiatal hernia in obese patients has proven difficult, as studies demonstrate poor symptom control and high failure rates in this patient population. Recent data have shown that incorporating weight loss procedures into the treatment of reflux may improve overall outcomes.

Methods:

We retrospectively reviewed 28 obese and morbidly obese patients who presented from December 2007 through July 2013 with large or recurrent type 3 or 4 paraesophageal hernia. All of the patients underwent combined paraesophageal hernia repair and partial longitudinal gastrectomy. Charts were retrospectively reviewed, and the patients were contacted to determine symptomatic relief.

Results:

Mean preoperative body mass index was 38.1 ± 4.9 kg/m². Anatomic failure of prior fundoplication occurred in 7 patients (25%). The remaining 21 had primary paraesophageal hernia, 3 of which were type 4. Postoperative complications included pulmonary embolism (n = 1), pulmonary decompensation (n = 2), and wound infection (n = 1). Mean hospital stay was 5 ± 3 days. Upper gastrointestinal esophagogram was performed in 21 patients with no immediate recurrence or staple line dehiscence. Mean excess weight loss was 44 ± 25%. All of the patients surveyed experienced near to total resolution of their preoperative symptoms within the first month. At 1 year, symptom scores decreased significantly. At 27 months, however, there was a mild increase in the scores. Return of severe symptoms occurred in 2 patients, both of whom underwent conversion to gastric bypass.

Conclusions:

Combined laparoscopic paraesophageal hernia repair with longitudinal partial gastrectomy offers a safe, feasible approach to the management of large or recurrent paraesophageal hernia in well-selected obese and morbidly obese patients. Short-term results were promising; however, intermediate results showed increasing rates of reflux symptoms that required medical therapy or conversion to gastric bypass.     

腹腔镜Nissen胃底折叠术治疗老年胃食管反流病

目的:对比腹腔镜Nissen 胃底折叠术在老年组和非老年组胃食管反流病(GERD)的疗效,评价其在老年人应用的可行性.方法:回顾分析因GERD行腹腔镜Nissen胃底折叠术治疗的老年病人28例,随机选取同时期非老年GERD病人40例作为对照组,分析不同年龄组患者的治疗效果.结果:术后两组症状完全消失.食管下段压力由(8.8±2.6)mmHg(1mmHg =0.133 kPa)提高到(18.23±3.6)mmHg(P＜ 0.01),24 h pH值检测评分由105.4±3.7降低到8.12±2.1(P＜ 0.01),较术前明显改善,并达到正常范围.平均随访4.5年,非老年组症状复发2例,老年组1例.远期吞咽困难老年组发生8例,非老年组为1例,差异有统计学意义(P＜ 0.05).结论:在老年GERD病人中实施腹腔镜Nissen 胃底折叠术与在非老年病人中实施一样安全、有效,但远期吞咽困难发生率较非老年人为高.     

肥胖患者的腹腔镜辅助胃癌根治术

目的探讨肥胖因素对腹腔镜辅助胃癌根治术近期疗效的影响。方法回顾性分析我科2006年3月-2011年10月412例腹腔镜辅助胃癌根治术的临床资料,其中体重指数（body mass index,BMI）92594例（肥胖组）,BMI〈25318例（非肥胖组）,比较2组患者术中情况、术后恢复、手术并发症等指标。结果肥胖组手术时间明显长于非肥胖组[（220．7±40．4）min vs．（185．5±29．1）min,t=9．365,P=0．000],术中出血量明显多于非肥胖组[（132．1±34．1）mlvs．（106．2±18．6）ml,t=9．572,P=0．000],2组肛门排气时间虽有统计学差异,但无实际临床意义[（3．6±1．0）dVB．（3．4±0．8）d,t=2．005,P=0．046]。肥胖组淋巴结清扫数目为（20．8±7．5）枚,明显少于非肥胖组（27．1±8．7）枚（t=-6．356,P=0．000）。肥胖组与非肥胖组术后并发症发生率分别为19．1％（18／94）和13．2％（42／318）,无统计学差异（χ2=2．058,P=0．151）。2组围手术期死亡率分别为2．1％（2／94）和0．3％（1／318）,无统计学差异（P=0．132）。结论肥胖会延长腹腔镜辅助胃癌根治术的手术时间,影响淋巴结清扫,但不增加术后并发症发生率,开展初期应选择BMI〈25的非肥胖病例。     

Randomized controlled study: radiofrequency coagulation and plication versus ligation and excision technique for rectal mucosal prolapse

BACKGROUND: A novel technique of radiofrequency ablation and plication of the rectal mucosa (RAMP) as a treatment for rectal mucosal prolapse is reported. The results of this technique are compared with the conventional ligature and excision procedure (LEP). METHODS: Radiofrequency ablation was performed using an Ellman radiofrequency generator. Patients with rectal mucosal prolapse were randomized to undergo either LEP or RAMP. The intra- and postoperative outcomes and complications were recorded. RESULTS: RAMP on average resulted in reduced operation time, shorter hospitalization, and significantly less postoperative pain. Return to work was earlier and wound healing times were shorter than that of patients in the control group. The complication rates also were significantly shorter (9% in the RAMP group and 29% in the conventional LEP group). CONCLUSION: The procedure of radiofrequency ablation and plication of rectal mucosa is safe, effective, and swift. It can be proposed as an effective alternative to conventional surgical procedures.     

Endoscopic full-thickness plication for the treatment of GERD: long-term multicenter results

Background The purpose of the present study was to assess the long-term safety and durability of effect for endoscopic full-thickness plication for the treatment of symptomatic gastroesophageal reflux disease (GERD). The Plicator (NDO Surgical, Inc., Mansfield, MA) used delivers a transmural suture through the gastric cardia to restructure the antireflux barrier. Published reports have shown the Plicator procedure to be effective in reducing GERD symptoms and medication use at 1 year post-plication. Methods Twenty-nine patients with chronic heartburn requiring maintenance daily anti-secretory therapy were treated at five sites. Patients received a single full-thickness plication in the gastric cardia 1cm below the gastroesophageal junction (GE) junction. Re-treatments were not permitted. Patients were evaluated at baseline for GERD symptoms and medication use. Intermediate (12 month) and long-term subject follow-up (median follow-up: 36.4 months; range, 31.2–43.9 months) were completed to evaluate procedure safety and durability of effect. Results Twenty-nine patients completed the 12-month and 36-month follow-up. All procedure-related adverse events occurred acutely, and no new events were observed during extended follow-up. At 36-months post-procedure, 57% (16/28) of baseline proton pump inhibitor (PPI)-dependent patients remained off daily PPI therapy. Treatment effect remained stable from 12- to 36-months, with 21/29 patients off daily PPI at 12 months compared to 17/29 patients at 36-months. Median GERD- Health Related Quality of Life (HRQL) scores remained significantly improved at 36 months versus baseline off-meds scores (8 versus 19, p < 0.001). In addition, the proportion of patients achieving ≥ 50% improvement in GERD-HRQL score was consistent from 12 months (59%) to 36 months (55%). Conclusions Endoscopic full-thickness plication can reduce GERD symptoms and medication use for at least 3-years post-procedure. Treatment effect is stable from 1 to 3 years, and there are no long-term procedural adverse effects.     

Endoscopic full-thickness plication for the treatment of GERD: Five-year long-term multicenter results

Background The Plicator™ (NDO Surgical, Inc., Mansfield, MA) endoscopically places a full-thickness permanent suture to augment the antireflux barrier. At 3-years post-treatment, published results demonstrated a reduction in subjects’ gastroesophageal reflux disease (GERD) symptoms and related medication use. Aim To evaluate the Plicator’s safety and durability of effect at improving GERD symptoms at 5-years post-treatment. Methods A total of 33 chronic GERD sufferers across seven sites were followed for approximately 5 years (median follow-up: 59 months, range 50–65 months) after receiving a single full-thickness plication approximately 1 cm below the gastroesophageal (GE) junction in the anterior gastric cardia. At baseline, 30 out of 33 subjects required daily proton-pump inhibitor (PPI) therapy. Results Of the subjects who were PPI dependent prior to treatment 67% (20/30) remained off daily PPI therapy at 60 months and 5-year median GERD health-related quality-of-life (HRQL) scores show significant improvement from baseline off-meds scores (10 versus 19, p < 0.001). Additionally, 50% (16/32) of subjects achieved ≥ 50% score improvement in GERD-HRQL. No new adverse events were identified and all device-related events occurred acutely. These results were comparable to the results seen at 36 months follow-up. Conclusions Endoscopic full-thickness plication can reduce GERD symptoms and medication use for at least 5-years post procedure with no long-term adverse events post treatment.     

急性阑尾炎肥胖患者腹腔镜与开腹手术的对比研究

目的：探讨肥胖的急性阑尾炎患者行腹腔镜手术的效果及优缺点。方法回顾性分析2010年1月～2013年12月80例手术治疗肥胖的急性阑尾炎患者的临床资料,体重指数28～40。开腹组38例,腹腔镜组42例。比较2组手术时间、术中出血量、止痛药物及抗生素应用、术后发热、术后并发症、住院时间及费用的差异。结果腹腔镜组2例中转开腹。2组手术时间差异无显著性（P＞0．05）。与开腹组比较,腹腔镜组术中出血少[（14．98±12．77） ml vs．（31．58±19．00） ml, t＝-4．550, P＝0．000],术后抗生素使用时间短[（2．7±1．0） d vs．（4．1±1．2） d, t＝-5．470, P＝0．000],术后需要止痛少[5．0％（2／40） vs．26．3％（10／38）,χ2＝6．802,P＝0．009],留置引流少[2．5％（1／40） vs．18．4％（7／38）,χ2＝5．367, P＝0．021],术后发热少[5．0％（2／40） vs．23．7％（9／38）,χ2＝5．616, P＝0．018],术后切口愈合不良少[5．0％（2／40） vs．21．1％（8／38）,χ2＝4．493, P＝0．034],住院时间短[（5．9±3．2） d vs．（8．7±4．1） d, t＝-3．345, P＝0．001],但住院费用高[（7800±396）元vs．（4914±434）元, t＝30．716, P＝0．000]。结论对于肥胖的阑尾炎患者,腹腔镜阑尾切除术具有手术创伤小、术后恢复快、疼痛轻、并发症少、住院时间短等优点,住院费用可以接受,是首选治疗方法。     

双心房或单纯右心房射频消融术治疗成人先天性心脏病房间隔缺损合并心房颤动的对比研究

目的分析双心房射频消融术与单纯右心房射频消融术治疗成人先天性心脏病房间隔缺损合并心房颤动（房颤）的效果。方法回顾性分析2007年1月至2012年12月47例房间隔缺损合并心房颤动接受房间隔缺损修补联合射频消融术治疗患者的临床资料,其中男20例,女27例;年龄35～76岁;房颤病程3个月至15年;持续性房颤18例,长程持续性房颤29例。合并二尖瓣轻度至中度以上关闭不全10例,三尖瓣轻度至中度以上关闭不全28例。根据手术方式不同将47例患者分为两组,单纯右心房消融组（n=19）：行房间隔缺损修补术＋单纯右心房射频消融术;双心房消融组（n=28）：行房间隔缺损修补术＋双心房射频消融术。对于二尖瓣、三尖瓣存在轻一中度以上反流者,术中同期行二尖瓣、三尖瓣成形术。所有患者术后3个月、6个月、12个月均接受24h动态心电图检查,1年后间断门诊随访。结果双心房消融组的体外循环时间、主动脉阻断时间及术后住院时间较单纯右心房消融组略长,但两组术后早期并发症及恢复情况无明显差异。心脏复跳时,双心房消融组25例（89．3％）直接恢复窦性心律,3例为交界心律,无房颤心律。单纯右心房消融组14例（73．7％）直接恢复窦性心律,2例为交界心律,3例为房颤心律。出院时,双心房消融组28例（100％）均维持窦性心律;单纯右心房消融组15例（78．9％）维持窦性心律,4例房颤复发（P=0．045）。所有患者均得到随访,随访时间3～75个月,全组无死亡病例;房间隔无残余分流;2例出现二尖瓣轻一中度以上关闭不全,4例出现三尖瓣轻．中度以上关闭不全;双心房消融组术后2年累积窦性心律维持率为87．7％±6．7％,明显高于单纯右心房消融组的47．4％±11．5％（P=0．003）。结论对于成人房间隔缺损合并房颤,双心房射频消融术较单纯右心房射频消融术有更好的治疗效果,而且不会增加手术的风险。     

经皮热消融治疗可再手术切除的复发性肝细胞癌

目的评估经皮热消融治疗可再手术切除复发性肝细胞癌(RHCC)的临床疗效。方法 37例肝切除后 RHCC,肿瘤直径1.2～7.0 cm,平均(2.8±1.3)cm,临床评估可再切除但由于病人不愿意接受手术,采用超声引导经皮微波消融(MWA)或射频消融(RFA)治疗,观察局部疗效、治疗并发症和远期生存情况。结果肿瘤完全消融率(完全灭活率)91.9%(34/37),其中直径≤3 cm结节为95.8%、3 cm 以上者84.6%。并发症发生率5.4%(2/37),无治疗死亡。平均随访(20.5±14.4)个月,肿瘤局部复发与肝内远处复发率分别为21.2%、72.2%。消融后1、3年无瘤生存率分别为35.9%、17.4%,中位无瘤生存期为6.7个月;消融后1、3及5年累积生存率分别为70.0%、35.3%和35.3%,中位生存期为32.6个月;初次肝切除后1、3、5及10年生存率分别为85.1%、63.4%、41.0%和37.6%,中位生存期47.0个月。结论经皮热消融技术是可再手术切除 RHCC 的有效治疗手段。     

腹腔镜辅助阴式子宫切除术治疗肥胖型早期子宫内膜癌17例

目的探讨腹腔镜手术治疗肥胖患者早期子宫内膜癌的可行性及临床效果。方法2003年8月-2009年10月采用腹腔镜辅助下经阴道子宫切除术治疗17例体重指数≥30的I期子宫内膜癌,对于临床分期Ⅰβ、Ⅰε期患者同时淋巴结取样。结果手术时间（215±50）rain,术中出血量（231±88）ml,肠功能恢复时间（40±lO）h,术后住院（8．2±1．1）d。术中1例损伤膀胱,1例损伤肠道,经镜下修补处理后未引起临床后果;1例因合并糖尿病手术穿刺口部位术后1周出现脂肪液化;1例腹壁穿刺孔出现皮下淤血,经过延长换药时间及微波物理治疗后好转。16例随访3年存活,1例术后13个月阴道残端复发次年死于全身转移。结论在一定腹腔镜基本技能基础上,肥胖患者早期子宫内膜癌不再是腹腔镜手术的相对禁忌证。     

Treatment of Thoracic Esophageal Anastomotic Leaks and Esophageal Perforations with Endoluminal Stents: Efficacy and Current Limitations

Background  Intra-thoracic esophageal leakage after esophageal resection or esophageal perforation is a life-threatening event. The objective of this non-randomized observational study was to evaluate the effects of endoluminal stent treatment in patients with esophageal anastomotic leakages or perforations in a single tertiary care center. Methods  Thirty-two consecutive patients with an intrathoracic esophageal leak, caused by esophagectomy (n = 19), transhiatal gastrectomy (n = 3), laparoscopic fundoplication (n = 2), and iatrogenic or spontaneous perforation (n = 8), undergoing endoscopic stent treatment were evaluated. Hospital stay, mortality and morbidity, sealing rate, extraction rates, complications, and long-term effects were measured. Results  Median time interval between diagnosis and stent treatment was 3 and 5 days, respectively. Eighteen patients had futile surgical closure of the defect before stenting, while in 14 patients, stent placement was the primary treatment for leakage. Stent placement was technically correct in all patients. Functional sealing was achieved in 78%. Mortality was 15.6%. Stent extraction rate was 70%. Overall method-related complications occurred in nine patients (28%). Conclusions  Implantation of self-expanding stents after esophageal resection or perforation is a feasible and safe procedure with an acceptable morbidity even if used as last-choice treatment. Dirk Tuebergen and Emile Rijcken contributed equally to this work.     

肝切除联合术中热消融治疗肝硬化背景下多灶性肝癌

目的探讨肝切除联合术中热消融治疗肝硬化背景下多灶性肝癌的有效性和安全性。方法回顾性分析63例接受肝切除联合术中热消融治疗肝硬化背景下多灶性肝癌患者的临床资料,分析患者的治疗效果及并发症。结果 63例患者共切除病灶85个,病灶平均最大直径(4.66±3.82)cm,热消融治疗病灶146个,病灶平均最大直径(1.48±0.66)cm。146个病灶完全消融率达100%(146/146),局部复发率4.11%(6/146)。患者1、2、3、4年无瘤生存率分别为54.82%、31.28%、12.03%、6.02%;1、3、5年累积生存率分别为83.51%、56.83%、45.20%。未出现治疗相关的死亡病例。肝切除相关严重并发症8例(8/63,12.70%)。未出现热消融相关严重并发症。结论肝切除联合术中热消融治疗肝硬化背景下多灶性肝癌安全、有效,扩大了肝切除术的适应证。     

二尖瓣置换术同期行心房颤动射频消融术后房性心动过速的射频消融术治疗

目的随访风湿性心脏病患者行二尖瓣置换术同期行心房颤动射频消融术后的心律,探索发生房性心动过速（房速）患者的导管射频消融效果。方法纳入因风湿性心脏病行二尖瓣置换术同期行心房颤动外科消融术后发生房速的11例患者,在心动过速持续状态下采用三维电解剖标测系统,建立左心房或右心房标测图,根据标测结果选择心动过速的关键部位行射频消融术。男4例、女7例,平均年龄（49±8）岁。结果该组患者行外科手术时间为（149±18）min,术后住院时间（9．5±2．9）d,住ICU时间（1．8±0．4）d。在电解剖标测过程中,11例患者共标测出17种心动过速,其中5例患者（6例次,35％）起源于右心房,6例患者（11例次,65％）起源于左心房,其中2例与二尖瓣环有关。消融术中即时成功率为91％（10／11）。平均随访（17±4）个月后,2例左心房房速患者复发。结论该类患者发生的房速来自左心房居多,大多数非二尖瓣瓣环依赖,行导管射频消融术效果满意且安全。     

Prospective Assessment of Patient Selection for Antireflux Surgery by Combined Multichannel Intraluminal Impedance pH Monitoring

Introduction  Selecting gastroesophageal reflux disease (GERD) patients for surgery on the basis of standard 24-h pH monitoring may be challenging, particularly if this investigation does not correlate with clinical symptoms. Combined multichannel intraluminal impedance pH monitoring (MII-pH) is able to physically detect each episode of intraesophageal bolus movements, enabling identification of either acid or non-acid reflux episodes and thus establish the association of the reflux with symptoms. Materials and Methods  We prospectively assessed and reviewed data from 314 consecutive patients who underwent MII-pH for GERD not responsive or not compliant to proton pump inhibitor therapy. One hundred fifty-three patients with a minimum follow-up of 1 year constituted the study population. Clinical outcomes and satisfaction rate were collected in all patients who underwent laparoscopic Nissen–Rossetti fundoplication. Outcomes were reported for patients with normal and ineffective peristalsis and for patients with positive pH monitoring, negative pH monitoring and positive total number of reflux episodes at MII, and negative pH monitoring and normal number of reflux episodes at MII and a positive symptom index correlation with MII. Results  The overall patient satisfaction rate was 98.3%. No differences were recorded in the clinical outcomes of the patients with preoperative normal and ineffective peristalsis. No differences in patients’ satisfaction and clinical postoperative DeMeester symptom scoring system were noted between the groups as determined by MII-pH. Conclusion  MII-pH provides useful information for objective selection of patients to antireflux surgery. Nissen fundoplication provides excellent outcomes in patients with positive and negative pH and positive MII monitoring or Symptom Index association. More extensive studies are needed to definitively standardize the useful MII-pH parameters to select the patient to antireflux surgery.