Randomized Trial of Medical versus Surgical Treatment for Refractory Heartburn.

BACKGROUND: Heartburn that persists despite proton-pump inhibitor (PPI) treatment is a frequent clinical problem with multiple potential causes. Treatments for PPI-refractory heartburn are of unproven efficacy and focus on controlling gastroesophageal reflux with reflux-reducing medication (e.g., baclofen) or antireflux surgery or on dampening visceral hypersensitivity with neuromodulators (e.g., desipramine). METHODS: Patients who were referred to Veterans Affairs (VA) gastroenterology clinics for PPI-refractory heartburn received 20 mg of omeprazole twice daily for 2 weeks, and those with persistent heartburn underwent endoscopy, esophageal biopsy, esophageal manometry, and multichannel intraluminal impedance-pH monitoring. If patients were found to have reflux-related heartburn, we randomly assigned them to receive surgical treatment (laparoscopic Nissen fundoplication), active medical treatment (omeprazole plus baclofen, with desipramine added depending on symptoms), or control medical treatment (omeprazole plus placebo). The primary outcome was treatment success, defined as a decrease of 50% or more in the Gastroesophageal Reflux Disease (GERD)-Health Related Quality of Life score (range, 0 to 50, with higher scores indicating worse symptoms) at 1 year. RESULTS: A total of 366 patients (mean age, 48.5 years; 280 men) were enrolled. Prerandomization procedures excluded 288 patients: 42 had relief of their heartburn during the 2-week omeprazole trial, 70 did not complete trial procedures, 54 were excluded for other reasons, 23 had non-GERD esophageal disorders, and 99 had functional heartburn (not due to GERD or other histopathologic, motility, or structural abnormality). The remaining 78 patients underwent randomization. The incidence of treatment success with surgery (18 of 27 patients, 67%) was significantly superior to that with active medical treatment (7 of 25 patients, 28%; P = 0.007) or control medical treatment (3 of 26 patients, 12%; P<0.001). The difference in the incidence of treatment success between the active medical group and the control medical group was 16 percentage points (95% confidence interval, -5 to 38; P = 0.17). CONCLUSIONS: Among patients referred to VA gastroenterology clinics for PPI-refractory heartburn, systematic workup revealed truly PPI-refractory and reflux-related heartburn in a minority of patients. For that highly selected subgroup, surgery was superior to medical treatment. (Funded by the Department of Veterans Affairs Cooperative Studies Program; ClinicalTrials.gov number, NCT01265550.).

Laparoscopic distal pancreatectomy for retrieval of a proximally migrated pancreatic stent.

BACKGROUND AND OBJECTIVES: Pancreatic stents placed by ERCP are common in the treatment of benign and malignant pancreatic and biliary disease. Proximal migration of the stent into the duct occurs in 2% to 5% of cases, often resulting in pancreatitis. Although technically challenging, proximally migrated pancreatic stents can usually be removed endoscopically. Little has been written about surgical management of irretrievable stents, and no reports of laparoscopic approaches were found. METHODS: We report on a case of unsuccessful ERCP retrieval of a proximally migrated pancreatic stent. RESULTS: Using laparoscopy, we exposed the pancreas and used ultrasound to locate the distal end of the stent. We incised the pancreas at that point, removed the stent, and completed the distal pancreatectomy with splenectomy. DISCUSSION: Several case series on retrieval of migrated pancreatic stents are reviewed. CONCLUSION: Although ERCP is often successful and sometimes requires several attempts, we recommend surgical consultation after the first or second failed ERCP.

Transgastric natural-orifice transluminal endoscopic surgery peritoneoscopy in humans: a pilot study in efficacy and gastrotomy site selection by using a hybrid technique.

BACKGROUND: Diagnostic natural-orifice transluminal endoscopic surgery (NOTES) peritoneoscopy can easily be performed with standard endoscopic equipment in animal studies. The efficacy and optimal transgastric site for NOTES access in humans, however, has not been determined. OBJECTIVE: To characterize the efficacy of various anterior gastric access locations for diagnostic transgastric NOTES peritoneoscopy in humans. DESIGN: Prospective clinical study. SETTING: Tertiary-care center with experience in NOTES peritoneoscopy. PATIENTS: Patients undergoing planned laparoscopic gastrectomy or gastrotomy involving the anterior aspect of the stomach were eligible. INTERVENTIONS: An anterior gastric site for NOTES gastrotomy was chosen and transgastric NOTES access was independently established after laparoscopic abdominal exploration. Peritoneoscopy was then performed. The site of gastrotomy was closed as part of the intended laparoscopic procedure. MAIN OUTCOME MEASURES: The ability to visualize the abdominal and pelvic organs in all four quadrants was determined. Patients were evaluated postoperatively for complications. RESULTS: Eight patients requiring 9 procedures were studied. Gastrotomy sites were classified as body (n = 3), lesser curvature (n = 3), greater curvature (n = 1), fundus (n = 1), and antrum (n = 1). Satisfactory navigation could only be performed to the right upper and both lower quadrants. The left upper quadrant, specifically the spleen, was adequately visualized in only 1 case (11%), where the gastrotomy site was at the greater curvature. One patient developed a surgical site infection requiring oral antibiotic therapy. The median postoperative stay was 2 days (range, 0-3 days). LIMITATIONS: Small number of patients. CONCLUSION: NOTES peritoneoscopy with a gastrotomy on the anterior stomach permits adequate visualization of organs in the right upper and both lower quadrants. Visualization of the left upper quadrant and spleen is, however, limited unless access is gained on the greater curvature of the stomach. The accuracy of NOTES in identifying intra-abdominal pathology compared with laparoscopy remains to be determined.

Hybrid surgery: combined laparoscopy and natural orifice surgery.

Hybrid procedures combine laparoscopy and natural orifice surgery techniques. Some groups are currently using hybrid procedures to investigate the concepts of pure natural orifice surgery. Thus far, hybrid procedures have validated the safety of transgastric peritoneoscopy, although improved instrumentation is imperative before widespread clinical applications. As technical improvements develop from hybrid surgery, gastrointestinal endoscopy and abdominal surgery could be revolutionized.

Management of colorectal injuries during operation iraqi freedom: patterns of stoma usage.

BACKGROUND: Management of penetrating colorectal injuries in the civilian trauma population has evolved away from diversionary stoma into primary repair or resection and primary anastomosis. With this in mind, we evaluated how injuries to the colon and rectum were managed in the ongoing war in Iraq. METHODS: The records of Operation Iraqi Freedom patients evacuated to National Naval Medical Center (NNMC) from March 2004 until November 2005 were retrospectively reviewed. Patients with colorectal injuries were identified and characterized by the following: (1) injury type; (2) mechanism; (3) associated injuries; (4) Injury Severity Score; (5) levels of medical care involved in patient treatment; (6) time interval(s) between levels of care; (7) management; and (8) outcomes. RESULTS: Twenty-three patients were identified as having either colon or rectal injury. The average ISS was 24.4 (range, 9-54; median 24). On average, patients were evaluated and treated at 2.5 levels of surgically capable medical care (range, 2-3; median 2) between time of injury and arrival at NNMC, with a median of 6 days from initial injury until presentation at NNMC (range, 3-11). Management of colorectal injuries included 7 primary repairs (30.4%), 3 resections with anastomoses (13.0%), and 13 colostomies (56.6%). There was one death (4.3%) and three anastomotic leaks (30%). Total complication rate was 48%. CONCLUSIONS: Based upon injury severity, the complex nature of triage and medical evacuation, and the multiple levels of care involved for injured military personnel, temporary stoma usage should play a greater role in military casualties than in the civilian environment for penetrating colorectal injuries.

Preparing for the American Board of Surgery Flexible Endoscopy Curriculum: Development of multi-institutional proficiency-based training standards and pilot testing of a simulation-based mastery learning curriculum for the Endoscopy Training System.

BACKGROUND: The Fundamentals of Endoscopic Surgery (FES) exam is required for American Board of Surgery certification. The purpose of this study was to develop performance standards for a simulation-based mastery learning (SBML) curriculum for the FES performance exam using the Endoscopy Training System (ETS). METHODS: Experienced endoscopists from multiple institutions and specialties performed each ETS task (scope manipulation (SM), tool targeting (TT), retroflexion (RF), loop management (LM), and mucosal inspection (MI)) with scores used to develop performance standards for a SBML training curriculum. Trainees completed the curriculum to determine feasibility, and effect on FES performance. RESULTS: Task specific training standards were determined (SM-121sec, TT-243sec, RF-159sec, LM-261sec, MI-180-480sec, 7 polyps). Trainees required 29.5 ± 3.7 training trials over 2.75 ± 0.5 training sessions to complete the SBML curriculum. Despite high baseline FES performance, scores improved (pre 73.4 ± 7, post 78.1 ± 5.2; effect size = 0.76, p > 0.1), but this was not statistically discernable. CONCLUSIONS: This SBML curriculum was feasible and improved FES scores in a group of high performers. This curriculum should be applied to novice endoscopists to determine effectiveness for FES exam preparation.

CD154 blockade, sirolimus, and donor-specific transfusion prevents renal allograft rejection in cynomolgus monkeys despite homeostatic T-cell activation.

BACKGROUND: CD154-specific antibodies have been shown to prevent acute rejection in many preclinical models including nonhuman primates (NHPs). However, they have been ineffective in pilot clinical trials, suggesting a need for more robust preclinical analysis. One factor affecting the disparate results may be related to the recipient's immune activation state. Specifically, adult humans have a high percentage of memory-phenotype T cells compared to young animals. Postdepletional homeostatic repopulation has been shown to enrich for memory-phenotype T cells and interfere with CD154-based therapies in rodents. METHODS: We developed a NHP model nonspecifically enriched for peripheral memory-phenotype T cells. Thymectomized cynomolgus macaques underwent depletion with polyclonal anti-thymocyte globulin followed by repopulation. Peripheral phenotype was serially determined using polychromatic flow cytometry. In vitro response to donor and environmental antigens was also confirmed before and after manipulation. We then tested a regimen previously successful in rhesus monkeys combining anti-CD154, sirolimus, and donor-specific blood transfusion (DST), in a second primate species with and without the provocation of increased peripheral homeostatic T-cell activation. RESULTS: Monkeys that were thymectomized (n=3) and depleted recovered via homeostatic repopulation with a repertoire enriched for cells with a memory surface phenotype compared to unmanipulated controls (n=3). Despite a repertoire markedly enriched for memory-phenotype cells, the regimen effectively prevented acute rejection for the duration of therapy. CONCLUSIONS: Cynomolgus monkeys can be rendered memory phenotype enriched using homeostatic repopulation. Despite a generally activated T-cell repertoire, anti-CD154, sirolimus, and DST effectively prevents rejection in cynomolgus monkeys.

PEG "Rescue": a practical NOTES technique.

UNLABELLED: Dislodged percutaneous endoscopic gastrostomy (PEG) tubes occur commonly and may require urgent surgical intervention in a susceptible patient population. Natural orifice translumenal endoscopic surgery (NOTES) may facilitate PEG rescue and avoid the morbidity associated with contemporary surgical techniques. We report a case of a dislodged PEG tube in the early post-operative period with evidence of incomplete gastrocutaneous tract formation and intra-abdominal leakage. Bedside transgastric NOTES exploration facilitated peritoneoscopy, evacuation of intra-abdominal fluid, and re-establishment of the PEG tube through the original gastrotomy tract. Tube feeds were resumed and postoperative contrast fluoroscopy demonstrated no intra-abdominal leakage from the replaced PEG tube. No postoperative complications related to the NOTES procedure were noted at 30 days of follow-up. PEG rescue represents a unique, practical, and empowering application of the burgeoning experience of NOTES. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi: 10.1007/s464-007-9361-2) contains supplementary material, which is available to authorized users.

Benign pneumoperitoneum after colonoscopy: a prospective pilot study.

Benign pneumoperitoneum is asymptomatic free intraabdominal air and is reported to occur occasionally with colonoscopy. Management of benign pneumoperitoneum after colonoscopy is controversial and may depend on incidence or etiology. No previous studies prospectively investigated the incidence or inciting factors of benign pneumoperitoneum resulting from colonoscopy. In this study, 100 patients underwent colonoscopy and then radiography of the chest and abdomen to detect free air. The average age was 58 +/- 6.2 years, and 48 of the colonoscopies were therapeutic. No cases of benign pneumoperitoneum were detected, estimating the incidence at 0% to 3% for diagnostic and therapeutic colonoscopy. These data indicate that benign pneumoperitoneum attributable to colonoscopy is rare and possibly nonexistent. Given the paucity of data favoring the occurrence of benign pneumoperitoneum after colonoscopy, we advocate treating all cases of free intraabdominal air after colonoscopy as perforations.

Immune profiling: molecular monitoring in renal transplantation.

Molecular techniques have become a mainstay for most biomedical research. In particular, sensitive methods for gene transcript detection and advanced flow cytometry have been crucial in fostering our understanding of the basic mechanisms promoting allosensitization and adaptive immune regulation. These technologies have been validated in vitro, and in pre-clinical settings, and as such their clinical application is now clearly appropriate. It is becoming increasingly clear that these robust techniques hold much promise to better elucidate human transplant biology, and more importantly, guide clinical decision making with mechanistically-based information. This article will discuss our laboratory's use of several novel technologies, including gene polymorphism analysis, real-time polymerase chain reaction transcript quantification, and multi-color flow cytometry in clinical human renal transplantation. Specific technical methodology will be presented outlining keys for effective clinical application. Clinical correlations will be presented as examples of how these techniques may have clinical relevance. Suggestions for the adaptation of these methods for therapeutic intervention will be given. We propose that clinical transplantation should proceed in close step with modern molecular diagnostics.

Tolerance: is it achievable in pediatric solid organ transplantation?

Significant advances have been made in the understanding of allograft rejection. There is growing awareness that allograft acceptance, or tolerance, is also an active process rather than a passive absence of rejection. Mechanistic awareness of this process has spawned many preclinical strategies for the prevention of allograft rejection without the need for chronic immunosuppression. These therapies are currently entering clinical trials. This article reviews the prevailing therapies that hold promise for future clinical application. In particular, their application in children is discussed, as are biologic aspects of childhood immunity that may play a role in the success or failure of these strategies.

Femoral vessel injuries in modern warfare since Vietnam.

The incidence of lower extremity injuries is high in modern warfare; however the mortality rate from these injuries is low. Despite the overall low mortality of lower extremity injuries, many deaths in modern conflicts are due to femoral vessel injury. The modern warfare literature was reviewed. In Somalia, 1 of the 14 reported deaths was due to a laceration of the superficial femoral artery. In the Persian Gulf, three deaths were reported in an Army field hospital, one resulted from uncontrolled hemorrhage from a profunda femoris artery wound and two others resulted from traumatic amputations with consequent major arterial injury. Despite the advances in modern body armor, the groin is left unprotected. A strategy to help minimize U.S. casualties in modern warfare may be a method of field hemostasis specifically designed for femoral vessel injury.

Validity evidence for the Simulated Colonoscopy Objective Performance Evaluation scoring system.

BACKGROUND: Low-cost, objective systems to assess and train endoscopy skills are needed. The aim of this study was to evaluate the ability of Simulated Colonoscopy Objective Performance Evaluation to assess the skills required to perform endoscopy. METHODS: Thirty-eight subjects were included in this study, all of whom performed 4 tasks. The scoring system measured performance by calculating precision and efficiency. Data analysis assessed the relationship between colonoscopy experience and performance on each task and the overall score. RESULTS: Endoscopic trainees' Simulated Colonoscopy Objective Performance Evaluation scores correlated significantly with total colonoscopy experience (r = .61, P = .003) and experience in the past 12 months (r = .63, P = .002). Significant differences were seen among practicing endoscopists, nonendoscopic surgeons, and trainees (P < .0001). When the 4 tasks were analyzed, each showed significant correlation with colonoscopy experience (scope manipulation, r = .44, P = .044; tool targeting, r = .45, P = .04; loop management, r = .47, P = .032; mucosal inspection, r = .65, P = .001) and significant differences in performance between the endoscopist groups, except for mucosal inspection (scope manipulation, P < .0001; tool targeting, P = .002; loop management, P = .0008; mucosal inspection, P = .27). CONCLUSIONS: Simulated Colonoscopy Objective Performance Evaluation objectively assesses the technical skills required to perform endoscopy and shows promise as a platform for proficiency-based skills training.

Infarction of a lipoma of the lesser omentum: laparoscopic treatment of a rare condition.

Infarction of the lesser omentum is an infrequent occurrence and is unfamiliar to most clinicians. Patients with this condition present with insidious epigastric pain, peritonitis on examination, and a normal white blood cell count. The computed tomographic scan reveals a focal ill-defined inflammatory mass with attendant fat stranding along the lesser curve of the stomach. In most patients, the diagnosis is secured at operation, although analgesics alone might be sufficient for management of this benign inflammatory condition. We present a case with the classic findings that was managed laparoscopically. Greater familiarity with focal infarction of lesser omental fat might lead to more nonoperative management in the future.

Second-look laparoscopy after laparoscopic relief of strangulated small bowel obstruction.

Laparoscopy is increasingly used for the treatment of complex small bowel obstructions (SBO). Conventional treatment of strangulated bowel is segmental resection. We have used second-look laparoscopy to preserve bowel in 4 cases of strangulated SBO. Of the 17 patients with bowel obstruction treated laparoscopically 4 had ischemic bowel. The obstructions were relieved and second-look laparoscopy was performed 24 hours later. In 3 cases the bowel had largely regained its normal appearance; 1 case required resection based on persistent ischemia. An average of 20 cm of bowel was preserved per patient, and there were no complications in these 4 patients. In sum, we have shown second-look laparoscopy for strangulated SBO to be feasible, safe, and, in most cases, bowel conserving.