Natural-orifice transgastric endoscopic peritoneoscopy in humans: Initial clinical trial.

BACKGROUND: Natural-orifice translumenal endoscopic surgery (NOTES) is a possible advancement for surgical interventions. We initiated a pilot study in humans to investigate feasibility and develop the techniques and technology necessary for NOTES. Reported herein is the first human clinical trial of NOTES, performing transoral transgastric diagnostic peritoneoscopy. METHODS: Patients were scheduled to undergo diagnostic laparoscopic evaluation of a pancreatic mass. The findings of traditional laparoscopy were recorded by anatomical abdominal quadrant. A second surgeon, blinded to the laparoscopic findings, performed transgastric peritoneoscopy. Diagnostic findings between the two methods were compared and operative times and clinical course were recorded. Definitive care was based on findings at diagnostic laparoscopy. RESULTS: Ten patients completed the protocol with an average age of 67.6 years. All patients underwent diagnostic laparoscopy followed by successful transgastric access and diagnostic endoscopic peritoneoscopy. The average time of diagnostic laparoscopy was 12.3 minutes compared to 24.8 minutes for the transgastric route. Transgastric abdominal exploration corroborated the decision to proceed to open exploration made during traditional laparoscopic exploration in 9 of 10 patients. Peritoneal or liver biopsies were obtained in four patients by traditional laparoscopy and in one patient by the transgastric access route. Findings were confirmed by laparotomy in nine patients. Eight patients underwent pancreaticoduodenectomy and two underwent palliative gastrojejunostomy and/or hepaticojejunostomy. CONCLUSIONS: Transgastric diagnostic peritoneoscopy is safe and feasible. This study demonstrates the initial steps of NOTES in humans, providing a potential platform for incisionless surgery. Technical issues, including instrumentation, visualization, intra-abdominal manipulation, and gastric closure need further development.

Transgastric instrumentation and bacterial contamination of the peritoneal cavity.

INTRODUCTION: Natural orifice transluminal endoscopic surgery (NOTES) is a rapidly evolving technique providing access to the peritoneum utilizing an endoscope via a natural orifice. One of the most significant requirements of this technique is the need to minimize the risk of clinically significant peritoneal contamination. We report the bacterial load and contamination of the peritoneal cavity in patients requiring a gastrotomy Roux-en-Y gastric bypass (LSRYGB). METHODS: We prospectively studied 50 patients undergoing a gastrotomy with creation of a gastrojejunostomy during LSRYGB. We recorded the patient's proton-pump inhibitor (PPI) utilization preoperatively and sampled gastric contents without lavage. We also sampled peritoneal fluid prior to and after gastrotomy, noting the length of time the gastrotomy was open to the peritoneum. Each of the three samples was sent for bacterial colony counts, and culture with identification of species. RESULTS: Fifty patients underwent LSRYGB with a mean operative time of 93 min. The gastrotomy was open to the peritoneal cavity for an average of 18 min. Seventeen of 50 patients were on PPIs preoperatively, resulting in a significant difference in postgastrostomy peritoneal bacterial counts. The average number of colony-forming units (CFU) of the gastric aspirate was 22,303 CFU/ml. Peritoneal aspirates obtained for examination prior to creation of a gastrotomy showed no CFUs in 44 of 50 patients. Peritoneal sampling after gastrotomy showed contamination of the abdomen with an average of 1102 CFU/ml. There was no correlation between the bacterial load in the stomach and peritoneal load after gastrotomy. No infectious complications or leaks developed. One complication of rhabdomyolysis in a patient with no peritoneal bacterial contamination developed. CONCLUSIONS: Transgastric instrumentation does contaminate the abdominal cavity but pathogens are clinically insignificant due to species or bacterial load. Patients on PPIs do have an increased bacterial load in the gastric aspirate, with no clinical significant infection.

Impact of [18F]-2-fluorodeoxyglucose-positron emission tomography/computed tomography on previously untreated head and neck cancer patients.

OBJECTIVES: The role of fused modality [F]-2-fluorodeoxyglucose-positron emission tomography/computed tomography (PET/CT) in diagnosing and accurately staging patients with primary, metastatic, and recurrent head and neck (HN) cancer is evolving, and the clinical implications need to be further defined. A few retrospective studies have been performed, but adequate sample sizes are lacking because the number of HN cancer patients is relatively small. This study evaluates the positive predictive value (PPV), sensitivity, specificity, and accuracy of PET/CT in previously untreated HN cancer patients at a single tertiary care institution. The purpose of this study is to evaluate the role of this new technology in the management of previously untreated HN cancer patients. STUDY DESIGN: Retrospective cohort outcomes study at a tertiary National Cancer Institute Comprehensive Cancer Center. MATERIALS AND METHODS: Institutional review board exemption #4 (45 CFR 46.101 [4]) criteria were applied for and accepted by the office of responsible research practices at the Ohio State University College of Medicine. The authors identified 268 consecutive PET/CT examinations between March 2005 and January 2006 for HN cancer ordered by the two senior authors at the James Cancer Hospital and Solove Research Institute of the Ohio State University Medical Center. PET/CT examinations were interpreted by one of three neuroradiologists. PPV, sensitivity, specificity, accuracy, diagnostic upstaging, and treatment management changes were determined from subset analysis of 123 previously untreated patients with HN cancer. Synchronous lesions were detected in 10 patients with use of this modality. PET/CT was also used to help manage 22 patients with unknown primary HN cancer. The statistics were verified by comparing PET/CT results with surgical specimen histopathology. RESULTS: : PET/CT was true-positive in 82.9% (102/123), with a per patient PPV of 87.2% and a per lesion PPV of 89.4%. PET/CT was false-positive in 12.2% (15/123) of patients and had a false-positive rate of 8.3% when calculated per lesion. In 67 patients who underwent neck dissection, PET/CT had a PPV of 92.7%. The accuracy was 89.7% in 20 patients who had bilateral neck dissections. The unknown primary site was found in 72.7% (16/22) of patients with unknown primary HN cancer. Synchronous lesions were found in 8.1% of patients by PET/CT, with a PPV of 66.6%. Distant metastases were detected in 15.4% (19/123) of patients. Treatment was altered in 30.9% (38/123) of patients as a result of this imaging modality. CONCLUSIONS: The benefit of the PET/CT imaging modality resides in its fusion of anatomic detail of the HN region with the sensitivity of detecting tumors with increased metabolic activity at distant sites. Treatment was altered in 30.9% of our previously untreated HN cancer patients because of this imaging technique, with altered treatment including upstaging, diagnosing distant and unresectable disease, and working-up second primary malignancies. The false-positive findings did not result in additional morbidity to these patients. Although PET/CT is sensitive in detecting occult cervical nodal metastases, it does not yet have the ability to replace neck dissection as the diagnostic standard of care. This study supports the use of PET/CT in patients with newly diagnosed HN cancer because of its high PPV and superiority of detecting distant metastases and synchronous lesions.