Endoscopic anterior fundoplication with the Medigus Ultrasonic Surgical Endostapler (MUSE™) for gastroesophageal reflux disease: 6-month results from a multi-center prospective trial.

BACKGROUND: Both long-term proton pump inhibitor (PPI) use and surgical fundoplication have potential drawbacks as treatments for chronic gastroesophageal reflux disease (GERD). This multi-center, prospective study evaluated the clinical experiences of 69 patients who received an alternative treatment: endoscopic anterior fundoplication with a video- and ultrasound-guided transoral surgical stapler. METHODS: Patients with well-categorized GERD were enrolled at six international sites. Efficacy data was compared at baseline and at 6 months post-procedure. The primary endpoint was a ≥ 50 % improvement in GERD health-related quality of life (HRQL) score. Secondary endpoints were elimination or ≥ 50 % reduction in dose of PPI medication and reduction of total acid exposure on esophageal pH probe monitoring. A safety evaluation was performed at time 0 and weeks 1, 4, 12, and 6 months. RESULTS: 66 patients completed follow-up. Six months after the procedure, the GERD-HRQL score improved by >50 % off PPI in 73 % (48/66) of patients (95 % CI 60-83 %). Forty-two patients (64.6 %) were no longer using daily PPI medication. Of the 23 patients who continued to take PPI following the procedure, 13 (56.5 %) reported a ≥ 50 % reduction in dose. The mean percent of total time with esophageal pH <4.0 decreased from baseline to 6 months (P < 0.001). Common adverse events were peri-operative chest discomfort and sore throat. Two severe adverse events requiring intervention occurred in the first 24 subjects, no further esophageal injury or leaks were reported in the remaining 48 enrolled subjects. CONCLUSIONS: The initial 6-month data reported in this study demonstrate safety and efficacy of this endoscopic plication device. Early experience with the device necessitated procedure and device changes to improve safety, with improved results in the later portion of the study. Continued assessment of durability and safety are ongoing in a three-year follow-up study of this patient group.

Intrathecal narcotic infusion pumps for intractable pain of chronic pancreatitis: a pilot series.

OBJECTIVES: The aim of this study was to evaluate the efficacy of intrathecal narcotics pump (ITNP) as an alternative treatment for patients with pain from chronic pancreatitis (CP). ITNP offers the advantages of reversibility, lower total narcotic dose, and the pancreas remaining intact. METHODS: Thirteen patients (8 female, 5 male), with mean age 40.6 years (s.d. 9.6 years), who had experienced intractable upper abdominal pain from CP were reviewed. Each patient had multiple other failed treatment modalities, including partial pancreatic resection (n = 6). They were offered ITNP after a successful intraspinal opioid trial. Etiologies of CP included idiopathy (n = 3), cystic fibrosis (n = 2), alcohol (n = 2), and pancreas divisum (n = 6). RESULTS: The median duration of severe, intractable pain prior to ITNP was 6 years (2-22 years). The median follow-up time after ITNP was 29 months (range, 7-94 months). The ITNP was in situ for a mean duration of 29 months (range, 0.5-94 months). Seven patients had pump exchange or removal for various reasons; improvement of pain at month 53 (n = 1), meningitis (n = 1), meningitis with subsequent replacement (n = 1), pump failure at month 31, 68, 79, and 84 (n = 4). There were no deaths. The mean pain score prior to implantation (score = 8.3, s.d. = 0.9) was significantly higher than 1 year after (score = 2.7, s.d. = 1.9) (P < 0.01) and last follow-up (score = 0.75, s.d. = 2.1) (P < 0.01). The median oral narcotic dose before and 1 year after ITNP were morphine sulfate equivalents 337.5 mg per day (range, 67.5-1,320) and 40 mg per day (range, 0-1,680), respectively (P < 0.01). Two patients were considered failures, as they still require a high dosage of both oral and intrathecal medications to control their pain, despite significant pain-score improvement. One patient who was excluded due to meningitis was also considered a failure. Therefore, the overall success rate of ITNP based on an intention-to-treat analysis was 76.9% (10/13). The major complications of ITNP were central nervous system infection requiring pump removal (n = 1), cerebrospinal fluid leak requiring laminectomy (n = 1), and perispinal abscess with bacterial meningitis requiring pump removal (n = 1). CONCLUSIONS: This study shows the many risks and benefits of ITNP. A longer follow-up is awaited; such pumps appear to be one alternative to aggressive surgical intervention. Failed ITNP trials leave other options open. Therapeutic trials directly comparing pancreatectomy, ITNP, and implanted nerve stimulators are of interest.

Enteryx implantation for GERD: expanded multicenter trial results and interim postapproval follow-up to 24 months.

BACKGROUND: Enteryx implantation in the esophagus is an alternative therapy for patients with proton pump inhibitor (PPI) dependent GERD. Although this treatment resulted in highly significant improvement at 6 and 12 months, longer follow-up is needed to more fully assess the durability of these positive effects. METHODS: An open-label, international clinical trial was conducted in 144 PPI-dependent patients with GERD with follow-up at 6 and 12 months. In addition, the durability and the safety of the treatment were assessed for 24 months in 64 patients enrolled in a postapproval study. The primary study outcome measure was usage of PPI. Secondary outcomes in the multicenter trial were GERD health-related quality of life (GERD-HRQL) symptom score and esophageal acid exposure. RESULTS: At 12 months, PPI use was reduced > or =50% in 84%: 95% confidence interval (CI) [76%, 90%] and was eliminated in 73%: 95% CI[64%, 81%] of evaluable patients (intent-to-treat analysis 78%: 95% CI[70%, 84%] and 68%: 95% CI[60%, 76%], respectively). A GERD-HRQL < or =11 was attained in 78%: 95% CI[69%, 85%] of evaluable patients. Esophageal acid exposure (total time pH <4) was reduced by 31%: 95% CI[17%, 43%]. At 24 months, a > or =50% or greater reduction in PPI use was achieved in 72%: 95% CI[59%, 82%] and PPI use was eliminated in 67%: 95% CI[54%, 78%] of patients. CONCLUSIONS: This investigation provides evidence for sustained effectiveness and safety of implantation of Enteryx in the esophagus in PPI-dependent patients with GERD.

Wall stent-enhanced lateral pancreaticojejunostomy for small-duct pancreatitis.

HYPOTHESIS: The purpose of this study was to see if a small (<7 mm) pancreatic duct could be dilated to an acceptable diameter, allowing lateral pancreaticojejunostomy to decompress the pancreatic duct and relieve pain, while preserving pancreatic endocrine and exocrine function. DESIGN: Patients with chronic pancreatitis who had a small main pancreatic duct underwent progressive trans-ampullary dilation of the duct and subsequent placement of an expandable metallic wall stent (wallstent; Boston Scientific Microvasive Division, Natick, Mass). Approximately 14 days later, a lateral pancreaticojejunostomy was done. SETTING: A 400-bed university referral center hospital in an urban setting. PATIENTS: Thirty-five patients were selected from a large group with chronic pancreatitis. Thirty-one had pancreas divisum. All patients had undergone transendoscopic sphincterotomies and stenting before being accepted into the study. All had endoscopic retrograde cholangiopancreatography-proven chronic pancreatitis, and all ducts were observed to be 7 mm or smaller. INTERVENTIONS: Patients were selected after endoscopic sphincterotomy and stenting failed. Progressive transendoscopic duct dilation with plastic stents was carried out, and a 10-mm expandable metallic wall stent was placed prior to surgical decompression. Lateral pancreaticojejunostomy was performed. MAIN OUTCOME MEASURES: Patients were observed for pain relief, postoperative symptoms, analgesic use, glucose intolerance, and quality of life. All patients were seen or contacted by telephone, and their results were recorded. RESULTS: There were no operative deaths, but 26% of patients had complications. Seventy-one percent of patients reported that their pain was better than preoperatively. Three patients had subsequent pancreatic surgery. No new cases of diabetes occurred except in the 2 patients who underwent total pancreatectomy. CONCLUSIONS: In general, most patients feel that their lives were improved by the procedure. A quarter of the patients no longer take narcotics, and many have been able to resume a relatively normal lifestyle. Although this procedure is not a panacea for all patients with chronic pancreatitis and a nondilated duct, it is a reasonable alternative to resection.