CHICAGO (EGMN) – Several devices have been developed to endoscopically create an antireflux barrier for the treatment of gastroesophageal reflux disease. All either have failed to provide long-term symptom relief, have had significant complications, or were removed from the market. But a new device has experimentally provided the closest approximation to a standard Nissen fundoplication, according to Dr. Vic Velanovich.

Standard therapy for GERD is either medical, with proton pump inhibitors (PPIs), or surgical, with a laparoscopic or open antireflux operation. Endoscopic approaches have thus far not met with durable success, according to a presentation by Dr. Velanovich at the annual meeting of the Central Surgical Association.

However, he presented encouraging results from a small, single-site study of endoscopic endoluminal fundoplication in 23 patients using the EsophyX device (EndoGastric Solutions Inc.). This sterile, single-use instrument for incisionless fundoplication utilizes proprietary fastener technology to tighten the lower esophageal sphincter.

“I think the sweet spot for this procedure is going to be in patients with moderate symptoms that may be somewhat but not completely controlled with PPIs and aren’t symptomatic enough to want an operation,” said Dr. Velanovich, a surgeon at Henry Ford Hospital in Detroit. “Because I do think, compared with Nissen, it’s going to lose,” he said.

Patients in this study had symptomatic GERD or laryngopharyngeal reflux and a hiatal hernia of less than 2 cm. They had typical or atypical symptoms of reflux and no esophageal dysmotility or other esophageal pathology, such as Barrett’s esophagus. Pathologic acid reflux was confirmed by 24-hour pH monitoring.

During this procedure, a surgeon operated the EsophyX device while an endoscopist maneuvered the endoscope. The patients received general endotracheal anesthesia and were first positioned in the left lateral decubitus position and then in a 45-degree left lateral position.

“The device is fussy,” said Dr. Velanovich. “Advancing the H-fastener takes time to get right. The objective is to create an omega-shaped valve approximately 3-5 cm in length.”

Because the procedure is new, Dr. Velanovich admitted patients overnight, and scheduled follow-up visits at 1 week and 6-8 weeks. The 23 patients (14 women, 9 men) had a mean age of 54 years, and 4 had had prior Nissen fundoplication.

After the intervention, 11 patients were completely symptom free, 5 had persistent symptoms, 3 reported mild transient symptoms, and 2 reported much-improved heartburn but not complete relief. The procedure was not completed in two patients because of their inability to pass the device. However, overall the study showed that the use of this device was safe and effective in the treatment of GERD.

Dr. Velanovich cautioned that the same strict criteria used to select patients for laparoscopic or open antireflux operations should be used for this intervention, and noted that patient positioning and predilation minimized adverse side effects.

Dr. Nathaniel Soper of Northwestern University Hospital, Chicago, asked Dr. Velanovich how extensively he expected the device to be used. “A number of techniques have been devised and have then fallen by the wayside,” noted Dr. Soper. “You’ve reported a short-term, small study with favorable results. How many indications are really candidates for this?” he asked.

“A very select group,” said Dr. Velanovich. “Small hiatal hernia, no other pathology. Probably a minority of patients, 8%-10% or less of my patients.” However, he added, “to my knowledge, nobody who’s had this done has been put back on PPIs. The alternative is a lap Nissen, which has a success rate of more than 90%, versus 80% for this. I think the people who go for this really don’t want an operation.”

Furthermore, he said, “these patients have less bloating and dysphagia, compared with a Nissen. The recovery actually is faster; most get back to normal activity within a few days.”

Asked about reimbursement, Dr. Velanovich said that the procedure requires preapproval, but that “only a handful have not been approved.”

Dr. Velanovich noted that Dr. Lars Lundell of Karolinska University Hospital, Stockholm, is organizing a placebo-based trial with a sham arm.

The study was sponsored by Henry Ford Hospital. Dr. Velanovich reported no relevant financial interests.

Dr. Gerald M. Fried, chair of the surgery department at McGill University, Montreal, was asked to comment on the study. In an interview, he said that “this study was an observational trial without any comparison to placebo, surgery, or medication. There were no physiologic outcomes reported. The outcome measured was GERD-Health related quality of life determined by questionnaire. Patient selection was very conservative, and not equivalent to those generally going for surgical treatment.

“At this point, this endoluminal treatment is of interest, but until it is compared with standards of care in a prospective blinded trial, or at least evaluated by post-treatment pH studies, its effectiveness is unproven,” said Dr. Fried, who was not involved in the study.

Copyright (c) 2009 Elsevier Global Medical News. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

芝加哥(EGMN)——对于胃食管反流病(GERD)的治疗，目前已研制出了数种可在内镜下建立抗反流屏障的装置。不过这些装置要么无法实现长期的症状缓解，或可能导致明显的并发症，要么已被撤市。但Vic Velanovich博士称，试验表明，一种新的装置能够产生与标准Nissen胃底折叠术最为接近的效果。

 

Velanovich 博士在中心外科协会2010年年会上的发言中称，GERD的标准治疗可以是以质子泵抑制剂(PPI)为主的内科治疗，或是以腹腔镜或开放性抗反流手术为主的外科治疗。到目前为止，内镜治疗的远期成功率都不高。

 

但Velanovich 博士报告了一项小规模单中心试验得到的令人鼓舞的结果。该试验采用EsophyX 装置(EndoGastric Solutions公司生产)在23例患者中施行了内镜下腔内胃底折叠术。这种用于无切口胃底折叠术的一次性无菌装置采用的是紧固件专利技术以收紧下食管括约肌。

 

美国底特律市Henry Ford医院的Velanovich 博士说：“我认为，这种治疗方法适用于那些表现出中度症状、PPI可在一定程度上控制这些症状但无法完全控制、且症状强度不足以令其愿意接受手术的GERD患者。因为我确实也承认这种手术的效果不及Nissen。”

 

该试验的受试者均患有症状性GERD或咽喉反流且食管裂孔疝小于2cm。患者均出现了典型或非典型反流症状且不伴食管运动功能障碍或其他食管病变，如Barrett食管。采用24h pH值监测以证实患者存在病理性反酸。

 

治疗过程中，在内镜师操纵内镜的同时由另一名外科医生来操作EsophyX装置。患者接受的是气管内全身麻醉，先采用左侧卧位，然后再改为45度左侧位。

 

Velanovich 博士说：“该装置需谨慎操作。将H形的紧固件放置到位需要花费一定的时间。目的是形成一个长约3~5cm的ω形活瓣。”

 

由于这是一种新的治疗方法，因此，Velanovich 博士在施术前一天晚上将患者收治入院，并于术后1周和6~8周安排了随访。这23例患者(14例女性，9例男性)的平均年龄为54岁，其中4例之前曾接受过Nissen胃底折叠术。

 

治疗后，11例患者症状完全消失，5例症状仍然持续，3例称仅有轻度一过性症状，2例称烧心症状大有改善但仍未完全缓解。其余2例患者由于该装置无法通过其食管而未能完成该治疗。但总的来说，该试验表明，这种装置用于GERD的治疗是安全且有效的。

 

Velanovich 博士提醒道，要施行这种干预措施，也必须采用与腹腔镜或开放性抗反流手术相同的严格标准来挑选患者。他还指出，患者的体位和预扩张处理可将不良反应的发生率降到最低。

 

美国芝加哥西北大学医院的Nathaniel Soper博士向Velanovich 博士提问：您预计该装置的使用范围会有多广？Soper博士指出：“到目前为止，研制出来的技术已有不少，但后来都未能得以广泛应用。您报告的只是一项短期小规模试验得到的阳性结果。那么这种干预措施的适应证到底有多广呢？”

 

Velanovich 博士回答道：“这只适用于很少一部分患者。食管裂孔疝要小，并且不能有其他食管病变。因此很可能只有少部分患者符合这些要求，估计8%~10%，也可能更少。”不过，Velanovich 博士补充道：“据我所知，接受了这种干预措施的患者都没有再重新用过PPI。对于这类患者，另一种可选方案便是腹腔镜Nissen术，这种手术的成功率在90%以上，而EsophyX的成功率也达到了80%。我想因GERD来就诊的患者其实都不愿意接受手术。”

 

Velanovich 博士说：“而且，与Nissen相比， EsophyX治疗后胃胀和吞咽困难的发生率更低。事实上患者恢复得更快；大多数患者可在数日内恢复正常活动。”

 

当问及治疗费用报销问题时，Velanovich 博士说，该治疗需要提前审批，但“只有少部分人没有通过审批。”

 

Velanovich 博士指出，瑞典斯德哥尔摩卡罗琳斯卡大学医院的Lars Lundell博士目前正在组织开展一项EsophyX安慰剂对照试验。

 

这项试验由Henry Ford医院资助。Velanovich 博士声明无相关经济利益冲突。

 

加拿大蒙特利尔麦吉尔大学外科主任Gerald M. Fried博士应邀对该试验作出评论。Fried博士在采访中说：“这是一项观察性试验，没有设置安慰剂、手术治疗或药物治疗等对照组。试验也没有报告患者的生理学指标，所测量的结局指标是基于问卷调查而确定的GERD-健康相关性生活质量。受试者的选择也相当保守，无法代表那些普遍都要接受手术治疗的患者。”

 

Fried博士说：“在这一点上，这种腔内治疗的确值得关注，但必须开展前瞻性盲法试验将其与标准治疗进行对照，或至少在治疗后通过pH值检测来进行评价，才能证实其疗效。” Fried博士没有参与这项试验。

 

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