Jobe Blair A, O'Rourke Robert W, McMahon Barry P, Gravesen Flemming, Lorenzo Cedric, Hunter John G, Bronner Mary, Kraemer Stefan J M
Division of Thoracic and Foregut Surgery, Heart, Lung and Esophageal Surgery Institute, University of Pittsburgh, Pittsburgh, Pennsylvania 15232, USA.
Ann Surg. 2008 Jul;248(1):69-76. doi: 10.1097/SLA.0b013e31817c9630.
To determine the safety, mechanism of action, immediate postprocedural anatomic impact on the esophagogastric junction, and short-term efficacy of the first entirely endolumenal antireflux procedure.
A safe and effective endoscopic antireflux procedure remains elusive. Transoral endolumenal surgery has enormous potential for the treatment of gastroesophageal reflux disease (GERD) and other esophagogastric diseases. A canine model was used to study a novel endoscopic device, which allows for creation of an endoluminal fundoplication.
The transoral incisionless fundoplication (TIF) was performed in 21 canines in a phase I feasibility and safety study, and in 21 canines in a phase II study that included a detailed objective assessment of the effects of 2 variants of the TIF procedure (TIF 1.0 and TIF 2.0) versus sham on esophageal physiology and esophagogastric junction (EGJ) anatomy.
In phase I, TIF provided a safe and feasible endolumenal therapy for GERD, with histologic data that demonstrated serosal fusion of approximated full-thickness tissue plications and durability of the fundoplication. TIF procedures effectively reduced cardia circumference and improved Hill classification grade. In phase II, the TIF 2.0 procedure achieved normalization of distal esophageal acid exposure and increased lower esophageal sphincter (LES) pressure and length based on objective testing over a 2-week period. TIF 2.0 demonstrated superior results to TIF 1.0, and valve appearance and location exhibited similarity to the Nissen fundoplication by vector volume analysis.
The TIF procedure is safe and results in a durable and functional fundoplication as well as a platform for further development and modification of the procedure, which can be use to impact outcome. This work provides the foundation for human translation and assessment of long-term outcomes.
确定首例完全腔内抗反流手术的安全性、作用机制、术后即刻对食管胃交界部的解剖学影响以及短期疗效。
安全有效的内镜抗反流手术仍难以实现。经口腔内手术在治疗胃食管反流病（GERD）和其他食管胃疾病方面具有巨大潜力。采用犬类模型研究一种新型内镜设备，该设备可用于创建腔内胃底折叠术。
在一项I期可行性和安全性研究中，对21只犬实施经口无切口胃底折叠术（TIF），在一项II期研究中，对另外21只犬实施该手术，II期研究包括对TIF手术的2种变体（TIF 1.0和TIF 2.0）与假手术对照，详细客观评估其对食管生理和食管胃交界部（EGJ）解剖的影响。
在I期，TIF为GERD提供了一种安全可行的腔内治疗方法，组织学数据显示近似全层组织皱襞的浆膜融合以及胃底折叠术的持久性。TIF手术有效减小了贲门周长并改善了希尔分级。在II期，基于为期2周的客观测试，TIF 2.0手术使远端食管酸暴露恢复正常，并增加了食管下括约肌（LES）压力和长度。TIF 2.0的结果优于TIF 1.0，通过向量体积分析，瓣膜外观和位置与nissen胃底折叠术相似。
TIF手术安全，可形成持久且功能性的胃底折叠术，也是该手术进一步发展和改良的平台，可用于影响手术效果。这项工作为人体试验及长期疗效评估奠定了基础。
