Hybrid natural orifice transluminal endoscopic surgery (NOTES) for Roux-en-Y gastric bypass: an experimental surgical study in human cadavers.

BACKGROUND AND STUDY AIMS: The advantages of a hybrid natural orifice transluminal endoscopic surgery approach to Roux-en-Y gastric bypass (hNOTES-RYGBP) might include: easier access to the peritoneal cavity, reduced number of ports and related complications, improved cosmesis, and others. However, currently available conventional endoscopic and laparoscopic instruments might be unsuitable for complex surgical procedures using transluminal access. The aim of this study was to investigate the feasibility and limitations of a NOTES RYGBP. METHODS: hNOTES-RYGBP was performed in human cadavers. Pouch creation was achieved by needle-knife dissection using a transvaginal, flexible scope. Articulating linear staplers were placed transumbilically to transect the stomach. Measurements of the small bowel were accomplished intraluminally or with flexible and rigid graspers. New methods were tested to create the gastro-jejunal anastomosis. A linear laparoscopic stapler was used to form the jejuno-jejunal anastomosis. RESULTS: Stapler manipulation and anvil docking, bowel manipulation and measurement, and tissue dissection presented the main obstacles for hNOTES-RYGBP. Conventional instruments were too short for some transvaginal manipulations. The time to complete the procedure was 6 - 9 hours. It was feasible to perform a complete hNOTES-RYGBP in four out of seven cadavers. Two cadavers were unsuitable due to anatomical abnormalities or advanced decay. One procedure was terminated before completion because of time constraints. Combinations of flexible and rigid visualization and manipulation were helpful, especially for dissection and gastric pouch creation. CONCLUSIONS: Several factors made hNOTES-RYGBP very challenging and time-consuming. A lack of proper instrumentation resulting in insufficient tissue traction, countertraction, and instrument manipulation complicated several steps during the procedure. A combination of flexible with rigid endoscopic techniques offers specific advantages for components of this type of surgery. Changes in instrument design are required to improve more complex endosurgical procedures.

Sphincter of Oddi dysfunction: pancreaticobiliary sphincterotomy with pancreatic stent placement has a lower rate of pancreatitis than biliary sphincterotomy alone.

BACKGROUND AND STUDY AIMS: Patients with suspected or documented sphincter of Oddi dysfunction (SOD) who undergo standard biliary sphincterotomy have high rates of post-procedure pancreatitis. Approximately 75% of such patients have elevated basal pressures of the pancreatic sphincter. Biliary sphincterotomy (BES) on its own leaves the pancreatic sphincter unablated and may cause transient edema which aggravates the increase in pancreatic sphincter pressure. Combined pancreaticobiliary therapy (PBR), using pancreatic stenting in addition to sphincterotomy may therefore be safer. PATIENTS AND METHODS: The endoscopic retrograde cholangiopancreatography (ERCP) database was queried for patients with successful double-duct sphincter of Oddi manometry (SOM) who underwent BES alone or PBR between 1994 and 1997. The endoscopist had decided on the technique to be used. From 1995 to 1997 there was a general trend to do PBR. Pancreatitis was defined according to established criteria. RESULTS: The post-ERCP pancreatitis rate among all 436 SOD patients was 19.7%, while 256 patients with normal SOM results had a pancreatitis rate of 12.9%. The use of combined PBR was associated with a lower frequency of pancreatitis compared with BES alone (needle-knife over pancreatic duct stent, 14/131 patients, 10.7 %; pull-type pancreaticobiliary sphincterotomy plus pancreatic stent, 15/78 patients, 19.2%; BES alone, 52/184 patients, 28.3%). Episodes of moderate and severe pancreatitis were seen more frequently in the BES group. CONCLUSION: In SOD patients, post-ERCP pancreatitis rates remain high, but have improved with the addition of combined pancreaticobiliary sphincter therapy.

Same-day discharge after endoscopic biliary sphincterotomy: observations from a prospective multicenter complication study. The Multicenter Endoscopic Sphincterotomy (MESH) Study Group.

BACKGROUND: Same-day discharge after endoscopic biliary sphincterotomy (ES) is a common clinical practice, but there have been few data to guide appropriate selection of patients. Using a prospective, multicenter database of complications, we examined outcomes after same-day discharge as it was practiced by a variety of endoscopists and evaluated the ability of a multivariate risk factor analysis to predict which patients would require readmission for complications. METHODS: A 150-variable database was prospectively collected at time of ES, before discharge and again at 30 days in consecutive patients undergoing ES at 17 centers. Complications were defined by consensus criteria and included all specific adverse events directly or indirectly related to ES requiring more than 1 night of hospitalization. RESULTS: Six hundred fourteen (26%) of 2347 patients undergoing ES were discharged on the same day as the procedure, ranging from none at 6 centers to about 50% at 2 centers. After initial observation and release, readmission to the hospital for complications occurred in 35 (5.7%) of 614 same-day discharge patients (20 pancreatitis and 15 other complications, 3 severe). Of the same-day discharge patients, readmission was required for 14 (12.2%) of 115 who had at least one independently significant multivariate risk factor for overall complications (suspected sphincter of Oddi dysfunction, cirrhosis, difficult bile duct cannulation, precut sphincterotomy, or combined percutaneous-endoscopic procedure) versus 21 (4.2%) of 499 without a risk factor (odds ratio 3.1: 95% confidence interval [1.6, 6.3], p < 0.001). Of complications presenting within 24 hours after ES, only 44% presented within the first 2 hours, but 79% presented within 6 hours. CONCLUSIONS: Same-day discharge is widely utilized and relatively safe but results in a significant number of readmissions for complications. For patients at higher risk of complications, as indicated by the presence of at least one of five independent predictors, observation for 6 hours or overnight may reduce the need for readmission.

Therapeutic biliary endoscopy.

Therapeutic biliary endoscopy continues to evolve; some small but important developments were seen during the last year. Competing technologies are continuing to develop.

Technology assessment status evaluation: balloon dilation of gastrointestinal tract strictures. American Society for Gastrointestinal Endoscopy.

Balloon dilation is an acceptable modality for the dilation of stenoses at various sites in the gastrointestinal tract. In the esophagus its reported efficacy and safety is similar to bougienage; in other sites it offers an alternative to surgical treatment, in most cases as the definitive therapy.

Technology assessment status evaluation: monitoring equipment for endoscopy. American Society for Gastrointestinal Endoscopy.

An understanding of the principles and limitations of monitoring devices is valuable for their appropriate use and interpretation. Reliable monitoring de available as an adjunct to skilled personnel to detect changes in patient condition during endoscopy. Combination units that provide pulse oximetry, automated sphygmomanometry and ECG monitoring appear to be the most convenient and cost effective products.

Technology assessment status evaluation: disposable endoscopic accessories. American Society for Gastrointestinal Endoscopy.

Data supporting the preferential use of disposable endoscopic accessories is limited. These devices have been widely disseminated without careful evaluation of their impact on the environment and medical costs. In addition, current facility reimbursement for endoscopic procedures does not adequately cover the costs of these accessories. Re-use of accessories labelled "for single use only" as a potential means to reduce costs has not been carefully evaluated. More prospective data comparing the efficacy, safety, and cost effectiveness of disposable versus reusable accessories is needed.

Biliary tract complications after orthotopic liver transplantation. Endoscopic approach to diagnosis and therapy.

This study was undertaken to further define the role of endoscopic methods in the evaluation and treatment of biliary tract complications after liver transplantation and to determine the efficacy and safety of this approach. Fifty liver transplant patients were referred for endoscopic evaluation of a suspected biliary tract complication. Two patient groups were identified based on the indication for the endoscopic retrograde cholangiopancreatography (ERCP): Group 1 was suspected of having biliary fistula and group 2 was suspected of having bile duct obstruction. Group 1 consisted of 35 patients who developed bile peritonitis after inadvertent migration of the T-tube or intentional T-tube removal. Group 2 consisted of 15 patients who developed cholestatic hepatic chemistries in the absence of allograft rejection on liver biopsy. ERCP identified a biliary fistula at the T-tube insertion site into the bile duct in 32 (91%) group 1 patients. Twenty-six of 26 treated with a nasobiliary tube had fistula closure at a mean 5.2 days. Five of 6 treated with a stent, with or without sphincterotomy, had no leak at the time of stent removal (mean, 45 days). ERCP identified a cause for the cholestatic hepatic chemistries in 11 (73.5%) group 2 patients, including bile duct stones (n = 4), anastomotic (n = 3) or intrahepatic (n = 2) strictures, bile duct necrosis (n = 1), and hemobilia (n = 1). Five of the 5 patients undergoing endoscopic therapy were treated successfully. The endoscopic complication rate was 4% and the 30-day mortality rate was 2%. During a mean follow-up of 15 months, 94% of the patients who were treated successfully had no recurrent biliary tract disease. The results of this study suggest that ERCP is an effective modality in the evaluation of patients with suspected biliary tract complications after liver transplantation. In selected patients, endoscopic therapy obviates the need for additional surgical or percutaneous intervention.

Endoscopic retrograde cholangiopancreatography in pregnancy.

BACKGROUND: Pancreaticobiliary disease in pregnancy is relatively uncommon. The frequency of choledocholithiasis in pregnancy requiring intervention has been reported to be as low as one in 1200 deliveries. Traditionally, intervention in these patients has been surgical. Although surgery has an overall low morbidity and mortality for the expectant mother, it carries with it a 4- to 6-wk recovery period and a possibly increased risk of fetal wastage. Published information regarding the role and safety of ERCP in pregnancy is limited. This series of 23 pregnant patients undergoing ERCP was collected from six different medical centers. METHODS: Twenty-three pregnant patients with symptomatic pancreaticobiliary disease underwent a total of 29 ERCPs (three patients had diagnostic ERCP, and 20 had therapeutic ERCP). Fifteen, eight, and six procedures were performed in the first, second, and third trimesters, respectively. The only ERCP complication was pancreatitis in one patient. There was one spontaneous abortion (3 months after ERCP) and one neonatal death; however, casual relationship to ERCP was not apparent. CONCLUSION: Diagnostic and therapeutic ERCP appears reasonably safe and effective in pregnancy. Cautious and selective use of this procedure offers a viable alternative to surgery or observation in patients with emergent pancreaticobiliary problems.

Survey of informed consent for endoscopic retrograde cholangiopancreatography.

Prior to performance of gastrointestinal endoscopic procedures, physicians are generally required to appraise patients of potential risks, benefits, and alternatives. Components of the informed consent process require that: (1) consent be voluntary; (2) the patient be sufficiently mentally capable to engage in rational decision-making; and (3) "adequate information" be conveyed. Controversies reflected in both medical and legal literature concern the definition of "adequate information." To sample current opinion regarding consent for both diagnostic and therapeutic ERCP, members of the Indiana Gut Club and Midwest Gut Club were polled. From this group of academic and private practice physicians, 81 completed evaluations were compiled. Greater than 90% of physicians believed that pancreatitis and pancreatitis/bleeding/perforation must be mentioned for diagnostic and therapeutic ERCP, respectively. There was variation of opinion as to whether patients must be informed of potential need for surgery, prolonged hospital stay, or death. The performing physician was felt to be ultimately responsible for obtaining consent, although other health-care team members, excluding a secretary, could participate.

Effect of prophylactic main pancreatic duct stenting on the incidence of biliary endoscopic sphincterotomy-induced pancreatitis in high-risk patients.

Pancreatitis is a common complication of endoscopic sphincterotomy. Cautery-induced papillary edema has been implicated as a possible cause. The objective of this study was to determine whether prophylactic stenting of the main pancreatic duct after endoscopic sphincterotomy in high-risk patients would reduce the incidence of pancreatitis. High-risk patients were defined as those with sphincter of Oddi dysfunction, small common bile duct diameter (< 10 mm), or those requiring pre-cut sphincterotomy. Patients were studied in a prospective fashion from October 1990 to April 1992 and were randomized to receive either a main pancreatic duct stent or no stent after biliary sphincterotomy. The stents were generally removed 10 to 14 days after placement. Fifty patients were randomized to the no-stent group and 48 patients were randomized to the stent group, but in five patients stent placement was unsuccessful. Pancreatitis occurred in 18% of patients in the no-stent group compared with 14% of patients in the stent group. Most cases of pancreatitis were mild, occurring in 10% of patients in the no-stent group and 12% of patients in the stent group. Moderate to severe pancreatitis occurred with an increased frequency in patients in the no-stent group (8%) compared with that in patients in the stent group (2%). Mean number of hospital days required to treat pancreatitis was 9.5 days in the no-stent group compared with 2.8 days in the stent group; however, none of these differences reached statistical significance. Small common bile duct diameter (< 6 mm) was found to be an independent risk factor for pancreatitis after endoscopic sphincterotomy.(ABSTRACT TRUNCATED AT 250 WORDS)

Sphincter of Oddi dysfunction in patients with intact gallbladder: therapeutic response to endoscopic sphincterotomy.

Increasing evidence exists of the occurrence of sphincter of Oddi dysfunction in patients with an intact gallbladder. Optimal therapy for such patients has not been defined. From 1989 to 1991, 35 patients with sphincter of Oddi dysfunction (abnormal basal sphincter pressure > 40 mm Hg) and an intact gallbladder were identified. The patients with abnormal ductography (except for duct dilation), pancreas divisum, or pancreato-biliary malignancy were excluded. All patients had disabling upper abdominal pain, which was quantified on a 0 = none to 10 = severe pain scale. All patients received standard endoscopic biliary sphincterotomy and were followed up for 4 to 26 months with a mean of 13 months. Initially, 27 of 35 patients (77%) showed at least 50% improvement in the pain score, whereas only 15 of the 27 remained improved throughout the follow-up interval. Patients who were unimproved or had relapses were offered cholecystectomy and 11 patients underwent the procedure. These patients were followed up after cholecystectomy for 2 to 24 months, with a mean of 13 months. Eight of 11 were improved. In summary, the combination of endoscopic sphincterotomy and selective cholecystectomy and minimal medical treatment resulted in a good and excellent response rate of 68%. Better techniques are needed to select patients who will respond to these therapies.

Peritoneal coccidioidomycosis associated with human immunodeficiency virus infection.

Peritoneal coccidioidomycosis is extremely rare. This report describes a patient infected with the human immunodeficiency virus who presented with unexplained ascites and was found to have peritoneal coccidioidomycosis. The ascites had a low serum-ascites albumin gradient, and laparoscopy showed peritoneal implants that grew Coccidioides immitis. This case is unique in several ways; this is the first case in which a patient's acquired immunodeficiency syndrome-defining illness was peritoneal coccidioidomycosis, and the serum-ascites albumin gradient determination as well as laparoscopy provided information critical to the diagnosis. This patient's dramatic response to systemic antifungal therapy, as evidenced by resolution of ascites and constitutional symptoms, underscores the importance of timely diagnosis and prompt therapy. In summary, this report reviews the previous cases of coccidioidal peritonitis and reports the first case in which localized peritoneal coccidioidomycosis was the acquired immunodeficiency syndrome-defining illness in a human immunodeficiency virus-infected patient.