Major advances have been made over the past decade developing minimally-invasive endoscopic, surgical and radiographic procedures in an attempt to decrease mortality, morbidity, hospital stay and overall health care costs in treating patients with abdominal disorders. The treatment of these common gastrointestinal disorders needs to be studied in randomized controlled clinical trials. Given my training and experience in surgical endoscopy and minimally invasive surgery (laparoscopy), I propose studying in the context of randomized controlled clinical trials three distinct areas of gastrointestinal disease in which major advances have occurred employing laparoscopy, endoscopy and interventional radiological techniques. The three principal projects for this mentored clinical research are the following: 1. Randomized controlled clinical trial of laparoscopic cholecystectomy with laparoscopic common bile duct exploration versus endoscopic retrograde cholangiopancreatography with sphincterotomy followed by laparoscopic cholecystectomy for patients with common bile duct stone disease. 2. Laparoscopic anti-reflux surgery versus long-term administration of proton pump inhibitors (lanzoprasole) for moderate to severe gastroesophageal reflux disease. 3. Intra-arterial chemoembolization alone versus intra-arterial chemoembolization plus laparoscopic, ultrasound-guided radiofrequency ablation for non-resectable hepatocellular carcinoma. All three protocols involve minimally invasive surgery and other therapies studied in a prospective randomized controlled fashion. While the technical expertise, equipment and facilities used to perform these procedures have been developed around the world, few randomized controlled clinical trials exist that critically examine outcome parameters for a sufficient period of time to document efficacy, safety, improved survival and overall cost benefits in the treatment of these disorders. These three trials will allow such an evaluation of minimally invasive procedures used to treat patients with common gastrointestinal disorders.
| Rogers, Stanley J; Cello, John P; Horn, Jan K et al. (2010) Prospective randomized trial of LC+LCBDE vs ERCP/S+LC for common bile duct stone disease. Arch Surg 145:28-33 |
