Endoscopic vs. laparoscopic gastrojejunostomy for duodenal obstruction: a randomized study in a porcine model.

BACKGROUND AND STUDY AIMS: Open or laparoscopic gastrojejunostomy is an established treatment for malignant duodenal obstruction but may be associated with significant morbidity and mortality. The purpose of this study was to develop a model for an entirely endoscopic gastrojejunostomy to treat duodenal obstruction, and to compare this with the laparoscopic technique. METHODS: During the first part of the study the endoscopic technique was developed and tested in porcine nonsurvival and survival experiments (n=12). During the second part of the study (n=10), endoscopic gastrojejunostomy for duodenal occlusion was compared with laparoscopic gastrojejunostomy in a survival randomized controlled trial (RCT). For both groups duodenal occlusion was achieved by the laparoscopic approach. RESULTS: In the RCT, the median times for laparoscopic vs. endoscopic gastrojejunostomy were 70 minutes (interquartile range [IQR] 65-75) vs. 210 minutes (IQR 197-220; P=0.01). There was a trend toward increased anastomotic diameter at necropsy in the laparoscopic group (2 cm, IQR 2-3) compared to the endoscopic group (1.8 cm, IQR 1.6-1.8; P=0.06). One animal in the endoscopic group died secondarily to bowel ischemia from volvulus of the jejunal loop. One animal in the laparoscopic group was prematurely sacrificed due to extensive pulmonary congestion and edema. All anastomoses were intact and patent. CONCLUSIONS: Purely endoscopic gastrojejunostomy using the developed technique and devices is feasible and can result in adequate relief of duodenal obstruction. Endoscopic anastomoses tend to be smaller than laparoscopic anastomoses, with the procedures being more time-consuming and associated with higher complication rates.

Quality of life following radiofrequency ablation of dysplastic Barrett's esophagus.

BACKGROUND AND STUDY AIMS: The impact of the diagnosis and treatment of dysplastic Barrett's esophagus on quality of life (QoL) is poorly understood. This study assessed the influence of dysplastic Barrett's esophagus on QoL and evaluated whether endoscopic treatment of dysplastic Barrett's esophagus with radiofrequency ablation (RFA) improves QoL. PATIENTS AND METHODS: We analyzed changes in QoL in the AIM Dysplasia Trial, a multicenter study of patients with dysplastic Barrett's esophagus who were randomly allocated to RFA therapy or a sham intervention. We developed a 10-item questionnaire to assess the influence of dysplastic Barrett's esophagus on QoL. The questionnaire was completed by patients at baseline and 12 months. RESULTS: 127 patients were randomized to RFA (n = 84) or sham (n = 43). At baseline, most patients reported worry about esophageal cancer (71 % RFA, 85 % sham) and esophagectomy (61 % RFA, 68 % sham). Patients also reported depression, impaired QoL, worry, stress, and dissatisfaction with the condition of their esophagus. Of those randomized, 117 patients completed the study to the 12-month end point. Compared with the sham group, patients treated with RFA had significantly less worry about esophageal cancer ( P=0.003) and esophagectomy ( P =0.009). They also had significantly reduced depression ( P=0.02), general worry about the condition of their esophagus ( P≤0.001), impact on daily QoL ( P=0.009), stress ( P=0.03), dissatisfaction with the condition of their esophagus ( P≤0.001), and impact on work and family life ( P=0.02). CONCLUSIONS: Inclusion in the treatment group of this randomized, sham-controlled trial of RFA was associated with improvement in disease-specific health-related quality of life. This improvement appears secondary to a perceived decrease in the risk of cancer.

Randomized controlled trial comparing endoscopic clips and over-the-scope clips for closure of natural orifice transluminal endoscopic surgery gastrotomies.

BACKGROUND AND STUDY AIM: Secure and reliable endoscopic closure is of paramount importance before clinical introduction of transgastric natural orifice transluminal endoscopic surgery (NOTES). Gastrotomy closure in humans using standard endoclips has been reported. The aim of this study was to assess the safety of standard endoclip closure and to compare it to a new over-the-scope clip (OTSC) specifically designed for gastrotomy closure. MATERIAL AND METHODS: Gastric wall puncture and balloon dilation followed by peritoneoscopy was carried out in 20 female swine. After randomization, closure of the gastric incision was performed using a tissue approximation grasper and either endoclips or OTSCs. RESULTS: Mean (+/- SD) time for gastrotomy closure using endoclips was 31.5 +/- 24.2 minutes (range 8 - 88 minutes) compared with 8.5 +/- 9.1 minutes (range 2 - 31 minutes) using OTSC (P = 0.002). No intraoperative complications occurred. Laparoscopic leak tests with insufflation and saline immersion demonstrated three minor leaks and one major leak in the endoclip closures. No leaks were observed in the OTSC group. At necropsy, complete sealing of the gastrotomy sites was found in all OTSC closures. Small, localized perigastric abscesses were observed in two animals in the OTSC group and in three animals in the endoclip group. One animal in the endoclip group was sacrificed prematurely due to signs of sepsis and was found to have gross peritonitis secondary to a leak. At necropsy, evidence of peritonitis was identified in two other animals in the endoclip group. CONCLUSION: NOTES gastrotomy closure using standard endoclips, even with a tissue approximation grasper, is associated with an increased risk of leakage and intra-abdominal infection compared with OTSC. The significance of perigastric abscesses, which were seen in both groups, warrants further investigation.

Effects of milk and milk products on rectal mucosal cell proliferation in humans.

Intake of dairy products and major dairy constituents (e.g., calcium) has been proposed to reduce the risk of colorectal cancer, although epidemiological studies have yielded inconclusive results. We conducted a randomized cross-over trial to test the effects of high- and low-dairy consumption diets on rectal mucosal proliferation, a possible intermediary marker for large bowel cancer. From a gastroenterology clinic at an academic medical center, we recruited 40 patients, ages 25-79 years, who had either a history of a large bowel adenoma or a first-degree relative with large bowel cancer. Participants completed a baseline questionnaire covering demographic characteristics, health history, and habits and a food frequency questionnaire. They were randomized to a 12-week diet of either high dairy intake (six dairy servings/day) or low dairy intake (<0.5 serving of dairy products/day), with an intervening 12-week washout period in which they were asked to resume their usual diet before crossing over to the alternate study diet for the last 12-week period of the study. Adherence to the study diets was monitored by a daily dairy intake checklist and periodic, unscheduled 24-h dietary recalls. Biopsies of the rectal mucosa were obtained at the beginning and end of each intervention phase. Two assays of rectal mucosal cell proliferation were performed: immunohistochemical determination of proliferating cell nuclear antigen and whole crypt mitotic count. We found no statistically significant changes in either of these proliferation measures as a result of high or low dairy intake. There was no correlation between the labeling index for proliferating cell nuclear antigen and whole crypt mitotic count; however, measures of the location and intensity of cell proliferation within the rectal crypt were highly correlated between the two assays. Thus, our study indicates that greater consumption of dairy products over a 12-week period does not change rectal mucosal cell proliferation.

Gastroesophageal-vulvar leiomyomatosis presenting over the course of 20 years.

Gastroesophageal-vulvar leiomyomatosis represents a rare syndrome of diffuse smooth muscle proliferation primarily in the gastroesophagus and vulva. To our knowledge, there are 19 cases reported in the literature, most associated with Alport's syndrome. We recently encountered a case not associated with Alport's syndrome, which had progressed over the course of 20 years. We used immunohistochemistry to further delineate the process. Leiomyomatosis appears to be a systemic disorder, with indolent proliferations of smooth muscle in areas that may not be clinically significant.

Clinical trial: a randomized, study comparing meperidine (pethidine) and fentanyl in adult gastrointestinal endoscopy.

BACKGROUND: There is little evidence to guide choice between meperidine (pethidine) and fentanyl for sedation for gastrointestinal endoscopy. AIM: To compare meperidine with fentanyl in terms of procedure time and analgesia. METHODS: Single centre randomized controlled trial. Patients received narcotic doses and midazolam at the discretion of the attending endoscopist who was unaware of narcotic assignment. Endoscopy and recovery times were then recorded. The main outcome was total procedure time, defined as endoscopy time plus recovery time. Patient discomfort was assessed prior to discharge via visual analogue scale (VAS). RESULTS: In total, 55 patients were randomized to meperidine [44 colonoscopy and 11 esophagogastroduodenoscopy (EGD)] and 56 to fentanyl (45 colonoscopy and 11 EGD). Total procedure time was shorter for those receiving fentanyl (mean = 87.7 min) than for those receiving meperidine (mean = 102.9 min) (P = 0.05). The difference between the groups was explained by a shorter mean recovery time in the fentanyl group (63.0 min) than in the meperidine group (76.2 min) (P = 0.07). Based on post procedure pain scores, examinations with meperidine (mean = 1.99) were less painful when compared with those receiving fentanyl (mean = 2.86, P = 0.03). CONCLUSIONS: Fentanyl shortened total procedure time by reducing recovery time. A simple change in narcotic choice could increase endoscopy unit efficiency.

Irritable bowel syndrome: classification and pathogenesis.

The irritable bowel syndrome (IBS), a chronic disorder of gut motility with a variable but continuous spectrum of clinical features, affects 15% of the population of developed countries. Its intestinal and extraintestinal symptoms arise principally from the global physiological changes that accompany emotional tension; but the advancing knowledge of neurohumoral control of gut motility has not yet revealed any features pathognomonic for IBS. Persons having IBS exhibit psychoneurotic traits in varying degree; and IBS patients (a minority of the whole) differ from nonpatients in having more severe life changes and in their learned illness behavior.

Disposable, sheathed, flexible sigmoidoscopy: a prospective, multicenter, randomized trial. The Disposable Endoscope Study Group.

A new fiberoptic sigmoidoscopic system has been developed that utilizes a disposable sheath to cover and protect all working surfaces of the endoscope from contamination. The reusable part of the endoscope has no air, water, or suction/biopsy channels. These are incorporated in the disposable sheath, which is easily removed after use to provide each patient with a contamination-free endoscope. A prospective, randomized, controlled trial was performed to compare the disposable, sheathed, flexible sigmoidoscope with standard sigmoidoscopes. Clinical evaluations of the new sigmoidoscope system were performed at 15 facilities. Visual analog rating scales were used to record evaluations of endoscope performance and reprocessing by endoscopists and reprocessing personnel. The time to perform procedures, depth of insertion, and total instrument downtime were also recorded. One hundred forty-three procedures (70 standard, 73 sheathed) were performed. No significant difference was found for overall depth of insertion (50 versus 48 cm), although fewer sheathed endoscopes reached to 60 cm than did standard endoscopes (51% versus 30%). The sheathed system had a slightly longer mean procedure time than the standard (5.6 versus 6.7 minutes), but a significantly shortened overall downtime (32.8 vs 8.1 minutes). The standard system was preferred by the endoscopists. Reprocessing personnel preferred the disposable system. The disposable sigmoidoscope system has important advantages of decreased instrument turn-around time and potentially increased staff and patient safety, and future models should be improved to meet physicians' concerns.

Antineuronal antibodies in idiopathic achalasia and gastro-oesophageal reflux disease.

BACKGROUND AND AIMS: The precise aetiology of achalasia is unknown although autoimmunity has been implicated and is supported by several studies. We screened sera from patients with achalasia or gastro-oesophageal reflux disease (GORD) to test for circulating antimyenteric neuronal antibodies. METHODS: Serum was obtained from 45 individuals with achalasia, 16 with GORD, and 22 normal controls. Serum was used in immunohistochemistry to label whole mount preparations of ileum and oesophagus of the guinea pig and mouse. Also, sections of superior cervical and dorsal root ganglia, and spinal cord were examined. RESULTS: Positive immunostaining of the myenteric plexus was detected in significantly more achalasia and GORD samples than control samples (achalasia, p<0.001; GORD, p<0.01), and immunoreactivity was significantly more intense with achalasia and GORD serum samples than controls (achalasia, p<0.01; GORD, p<0.05). There was no correlation between intensity of immunoreactivity and duration of achalasia symptoms. In most cases, achalasia and GORD sera stained all ileal submucosal and myenteric neurones, and oesophageal neurones. Immunostaining was not species specific; however, immunostaining was largely specific for enteric neurones. Western blot analysis failed to reveal specific myenteric neuronal proteins that were labelled by antibodies in achalasia or GORD serum. CONCLUSIONS: These data suggest that antineuronal antibodies are generated in response to tissue damage or some other secondary phenomenon in achalasia and GORD. We conclude that antineuronal antibodies found in the serum of patients with achalasia represent an epiphenomenon and not a causative factor.

Transoral, flexible endoscopic suturing for treatment of GERD: a multicenter trial.

BACKGROUND: A totally transoral outpatient procedure for the treatment of GERD would be appealing. METHODS: A multicenter trial was initiated that included 64 patients with GERD treated with an endoscopic suturing device. Inclusion criteria were 3 or more heartburn episodes per week while not taking medication, dependency on antisecretory medicine, and documented acid reflux by pH monitoring. Exclusion criteria were dysphagia, grade 3 or 4 esophagitis, obesity, and hiatus hernia greater than 2 cm in length. Patients underwent manometry, endoscopy, 24-hour pH monitoring, and symptom severity scoring before and after the procedure. Patients were randomized to a linear or circumferential plication configuration. Adverse procedural events were recorded. RESULTS: Mean 6-month symptom score changes demonstrated procedural efficacy. Heartburn severity and frequency as well as regurgitation all improved (p > 0.0001 for each). Twenty-four-hour pH monitoring showed improvement in number of episodes below pH of 4 at 3 and 6 months (p < 0.0007 and 0.0002) and percentage of total time the pH was less than 4 at 6 months (p < 0.011). Plication configuration did not affect symptoms or pH monitoring results. One patient had a self-contained suture perforation that was successfully treated with antibiotics. CONCLUSION: Endoscopic gastroplasty is safe. It is associated with reduced symptoms and medication use at 6 month follow-up in patients with uncomplicated GERD.