Relevant Clinical Trials for GI Surgeons: a Review of Recent Findings
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REVIEW ARTICLE
Relevant Clinical Trials for GI Surgeons: a Review of Recent Findings Adriana C. Gamboa 1 & Shishir K. Maithel 1 Received: 25 April 2020 / Accepted: 25 May 2020 # 2020 The Society for Surgery of the Alimentary Tract
Abstract Over the last decade, a number of practice-changing clinical trials have been published to guide the management of esophageal, gastric, liver, pancreas, appendiceal, and colorectal pathologies. The following review aims to provide a succinct summary of these important trials that merit further critical assessment by every gastrointestinal surgeon. After each review, per the Editors’ request, the authors have provided their humble opinion as to the clinical context and application of the data. Keywords Gastrointestinal surgery . Clinical trials . Esophageal surgery . Gastric surgery . Hepatobiliary surgery . Colorectal surgery
Introduction
Esophagus
The last decade has witnessed important advances in the field of gastrointestinal surgery spanning both the treatment and surgical approach for benign and malignant disease processes. Here we present some of the most important contemporary clinical trials relevant to the gastrointestinal surgeon with the aim of reviewing the details of each study and, at the Editors’ request, providing a humble clinical perspective as to the application of the data. An overview of each trial is provided in Table 1 in the order presented here.
Esophageal Reflux Disease
* Shishir K. Maithel [email protected] Adriana C. Gamboa [email protected] 1
Division of Surgical Oncology, Department of Surgery, Winship Cancer Institute, 1365B Clifton Road NE, Atlanta, GA 30322, USA
Clinical Trial Overview Approximately 10–40% of patients with gastroesophageal reflux disease (GERD) fail to respond to proton-pump inhibitors (PPI) and these patients have historically also had a limited response to surgery likely due to poor selection of patients with reflux-related symptoms but no clear reflux disease.1 The 2019 Randomized Trial of Medical versus Surgical Treatment for Refractory Heartburn by Spechler et al. (ClinicalTrials.gov number, NCT01265550) sought to evaluate the role of surgery in a carefully selected population of patients with PPI-refractory GERD. 2 Patients with a history of PPI-refractory heartburn underwent a 2-week course of twice-daily omeprazole and those with persistent symptoms were further evaluated with endoscopy and esophageal biopsy, esophageal manometry, and multichannel intraluminal impedance-pH monitoring for confirmation of reflux-related heartburn. Patients were subsequently randomized to laparoscopic Nissen fundoplication (n = 27), active medical treatment (omeprazole plus baclofen, with desipramine added depending on symptoms, n = 25), or control medical
Active medical vs control medical vs surgical (Nissen) POEM vs LHM
Aug 2012–Dec 2015
Recruitment period
Randomized phase III Gastric adenocarcinoma
Non-inferiority, T2-4aN0-3M0 randomized phase adenocarcinoma III Randomized phase III High-risk GIST
ARTIST (Lee, 2012)
CLASS-
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