Simon K. Wong

Effect of intravenous omeprazole on recurrent bleeding after endoscopic treatment of bleeding peptic ulcers.

BACKGROUND After endoscopic treatment of bleeding peptic ulcers, bleeding recurs in 15 to 20 percent of patients. METHODS We assessed whether the use of a high dose of a proton-pump inhibitor would reduce the frequency of recurrent bleeding after endoscopic treatment of bleeding peptic ulcers. Patients with actively bleeding ulcers or ulcers with nonbleeding visible vessels were treated with an epinephrine injection followed by thermocoagulation. After hemostasis had been achieved, they were randomly assigned in a double-blind fashion to receive omeprazole (given as a bolus intravenous injection of 80 mg followed by an infusion of 8 mg per hour for 72 hours) or placebo. After the infusion, all patients were given 20 mg of omeprazole orally per day for eight weeks. The primary end point was recurrent bleeding within 30 days after endoscopy. RESULTS We enrolled 240 patients, 120 in each group. Bleeding recurred within 30 days in 8 patients (6.7 percent) in the omeprazole group, as compared with 27 (22.5 percent) in the placebo group (hazard ratio, 3.9; 95 percent confidence interval, 1.7 to 9.0). Most episodes of recurrent bleeding occurred during the first three days, which made up the infusion period (5 in the omeprazole group and 24 in the placebo group, P<0.001). Three patients in the omeprazole group and nine in the placebo group underwent surgery (P=0.14). Five patients (4.2 percent) in the omeprazole group and 12 (10 percent) in the placebo group died within 30 days after endoscopy (P=0.13). CONCLUSIONS After endoscopic treatment of bleeding peptic ulcers, a high-dose infusion of omeprazole substantially reduces the risk of recurrent bleeding.

Peroral endoscopic myotomy for treatment of achalasia: from bench to bedside (with video).

BACKGROUND Peroral endoscopic myotomy (POEM) is a novel approach to performing esophageal myotomy through a long submucosal tunnel. OBJECTIVE This study aimed to investigate the feasibility and safety of POEM for treatment of achalasia. DESIGN Preclinical animal study and prospective clinical study. PATIENTS Consecutive patients diagnosed with achalasia with high-resolution manometry. INTERVENTIONS POEM was standardized for preclinical and clinical studies. After submucosal injection, a mucosal incision was made 15 cm above the gastroesophageal junction (GEJ). A long submucosal tunnel was created to extend below the GEJ. The endoscopic myotomy started 10 cm above and extended 2 cm below the GEJ. We first conducted a preclinical animal study to confirm the safety of POEM. POEM was then performed for the treatment of achalasia in humans. MAIN OUTCOME MEASUREMENTS Relief from dysphagia assessed by the dysphagia score and Eckhardt score. High-resolution manometry and pH monitoring were performed to evaluate the posttreatment effects and esophageal acid exposure. RESULTS Seven 30-kg porcine models underwent POEM in the survival study. All of the pigs survived except 1, which sustained pneumomediastinum. POEM was performed for the treatment of achalasia in 16 patients. The mean operating time was 117.0 ± 34.1 minutes. All patients tolerated food on day 2, with a contrast study confirming no leakage. The median follow-up was 176.5 days (range 98-230 days). The postoperative basal lower esophageal sphincter pressure was significantly reduced (mean reduction, 13.9 ± 14.5 mm Hg; P = .005) and 4-second integrated relaxation pressure of the GEJ (mean reduction, 10.1 ± 7.4 mm Hg; P = .001). Of these patients, 58.3% had a normalized 4-second integrated relaxation pressure, whereas 20% had excessive esophageal acid exposure after the procedure. There was a significant improvement in quality of life 6 months after POEM measured by the Short Form-36 questionnaire. LIMITATION Small sample size. CONCLUSIONS POEM is a feasible, safe, and effective treatment for achalasia.

Predicting success of metabolic surgery: age, body mass index, C-peptide, and duration score.

BACKGROUND Surgery is the most effective treatment of morbid obesity and leads to dramatic improvements in type 2 diabetes mellitus (T2DM). Gastrointestinal metabolic surgery has been proposed as a treatment option for T2DM. However, a grading system to categorize and predict the outcome of metabolic surgery is lacking. The study setting was a tertiary referral hospital (Taoyuan City, Taoyuan County, Taiwan). METHODS We first evaluated 63 patients and identified 4 factors that predicted the success of T2DM remission after bariatric surgery in this cohort: body mass index, C-peptide level, T2DM duration, and patient age. We used these variables to construct the Diabetes Surgery Score, a multidimensional 10-point scale along which greater scores indicate a better chance of T2DM remission. We then validated the index in a prospective collected cohort of 176 patients, using remission of T2DM at 1 year after surgery as the outcome variable. RESULTS A total of 48 T2DM remissions occurred among the 63 patients and 115 remissions (65.3%) in the validation cohort. Patients with T2DM remission after surgery had a greater Diabetes Surgery Score than those without (8 ± 4 versus 4 ± 4, P < .05). Patients with a greater Diabetes Surgery Score also had a greater rate of success with T2DM remission (from 33% at score 0 to 100% at score 10); A 1-point increase in the Diabetes Surgery Score translated to an absolute 6.7% in the success rate. CONCLUSION The Diabetes Surgery Score is a simple multidimensional grading system that can predict the success of T2DM treatment using bariatric surgery among patients with inadequately controlled T2DM.

Randomized Trial of Endoscopic Sphincterotomy With Balloon Dilation Versus Endoscopic Sphincterotomy Alone for Removal of Bile Duct Stones

BACKGROUND & AIMS Limited endoscopic sphincterotomy with large balloon dilation (ESBD) is an alternative to endoscopic sphincterotomy (ES) for removing bile duct stones, but it is not clear which procedure is most effective. We compared the 2 techniques in removal of bile duct stones. METHODS Between September 2005 and September 2011, 156 consecutive patients with suspected of having, or known to have, common bile duct stones were randomly assigned to groups that underwent ES or ESBD. Patients in the ESBD group underwent limited sphincterotomy (up to half of the sphincter) followed by balloon dilation to the size of the common bile duct or 15 mm, and patients in the ES group underwent complete sphincterotomy alone. Stones were then removed using standard techniques. The primary outcome was percentage of stones cleared, and secondary outcomes included procedural time, method of stone extraction, number of procedures required for stone clearance, morbidities and mortality within 30 days, and direct cost. RESULTS There was no significant difference between groups in percentage of stones cleared (ES vs ESBD: 88.5% vs 89.0%). More patients in the ES group (46.2%) than the ESBD group (28.8%) required mechanical lithotripsy (P = .028), particularly for stones ≥15 mm (90.9% vs 58.1%; P = .002). Morbidities developed in 10.3% of patients in the ES group and 6.8% of patients in the ESBD group (P = .46). The cost of the hospitalization was also significantly lower in the ESBD group (P = .034). CONCLUSIONS ESBD and ES clear bile stones with equal efficacy. However, ESBD reduces the need for mechanical lithotripsy and is less expensive; ClinicalTrials.gov number, NCT00164853.

A double-blinded randomized controlled trial of laparoendoscopic single-site access versus conventional 3-port appendectomy.

Objective:The aim of the current study was to perform a multicentered prospective double-blinded randomized controlled trial comparing laparoendoscopic single-site access (LESS) versus conventional three-port laparoscopic appendectomy (TPLA). Background:The clinical benefits and disadvantages of LESS appendectomy are uncertain. Methods:Between October 2009 and March 2011, consecutive patients admitted with clinical or radiological evidence of appendicitis were randomly assigned to receive either LESS or TPLA. The main outcome measurement was overall pain score. Secondary outcome measurements included operative time, conversion rates, morbidity rates, activity pain scores, activity scores, patient satisfaction, and cosmesis scores. Results:During the study period, 200 patients were recruited to the study. There were no significant differences in the morbidity rates, operative time, conversion rates, and postoperative recovery. There were also no differences in the overall pain score and pain score at rest. However, patients in the LESS group experienced significantly more pain upon coughing or standing and required more intravenous analgesics (P = 0.001, 0.038, and 0.035, respectively). Wound cosmesis and satisfaction scores on the contrary were better in the LESS group (P = 0.002 and P = 0.052). No differences in the quality-of-life assessments were present at 2 weeks after operation. Conclusions:LESS and conventional appendectomy resulted in similar perioperative outcomes. However, LESS appendectomy resulted in worst pain scores upon exertion and required a higher dosage of intravenous analgesics when compared with TPLA. On the contrary, wound cosmesis and satisfaction scores were better in the LESS group. Hence, adoption of the technique for appendectomy will depend on patient preferences and the presence of local expertise.

Functional performance and quality of life in patients with squamous esophageal carcinoma receiving surgery or chemoradiation: Results from a randomized trial

Objective:The aim of this study was to compare the 2-year functional performance and quality of life in patients with operable squamous cell carcinoma of the esophagus, who have received either surgery or definitive chemoradiation (CRT). Summary Background Data:The functional outcomes and quality of life in patients receiving esophagectomy or definitive CRT is uncertain. Methods:Data were extracted from the database of a prospective randomized controlled trial that included patients with resectable mid or lower thoracic esophageal cancers. The patients were randomized to either standard esophagectomy or definitive CRT. Quality of life assessments were performed using the EORTC QLQ-C30 and QLQ-OES24 modules. Other functional assessments included pulmonary and eating functions. Results:From July 2000 to December 2004, a total of 81 patients were enrolled into the study. No significant longitudinal changes were detected in the global health status in both groups upon available follow-up. Surgery was associated with worsened physical functioning and fatigue symptoms up to 6 months after treatment (P < 0.001 and P = 0.021, respectively) and these scales improved at 2 years. In terms of pulmonary function, dyspnoic and coughing symptoms were significantly worsened 3 months after surgery (P = 0.024 and P = 0.036, respectively) whereas symptoms in the CRT group progressively deteriorated over time. Concerning the eating function, both groups had improvements in dysphagia but there were frequent need for endoscopic intervention. This study has been registered with clinicaltrials.gov and the clinicaltrials.gov ID number is NCT01032967. Conclusion:Neither surgery nor definitive CRT significantly impaired the global health status of patients. Surgery was associated with a short-term negative impact in some aspects of health related quality of life assessments but these changes became insignificant 2 years after treatment. However, CRT was associated with progressive deteriorations in pulmonary function in the longer term.

Long-term survival outcomes after definitive chemoradiation versus surgery in patients with resectable squamous carcinoma of the esophagus: results from a randomized controlled trial

BACKGROUND The aim of this study was to report on the 5-year survival outcomes of patients with resectable esophageal carcinoma who were treated by definitive chemoradiotherapy (CRT) or standard esophagectomy. PATIENTS AND METHODS Between July 2000 and December 2004, 81 patients with resectable squamous cell carcinoma of the mid- or lower thoracic esophagus were randomized to receive esophagectomy or definitive CRT. The primary outcome was the overall survival and secondary outcomes included disease-free survival, morbidities and mortalities. RESULTS Forty-five patients received esophagectomy and 36 patients were treated by definitive CRT. The overall 5-year survival favors CRT but the difference did not reach statistical significance (surgery 29.4% and CRT 50%, P=0.147). A trend to improved 5-year survival was observed for patients suffering from node-positive disease (P=0.061). The 5-year disease-free survival also showed a trend to significance favoring CRT (P=0.068), particularly for patients suffering from node-positive disease (P=0.017). Both the stage of the disease and albumin level were significant predictors to mortality and disease-free survival. CONCLUSIONS Definitive CRT for squamous esophageal carcinoma resulted in comparable long-term survival to surgery. Further large-scale studies would be required to further investigate the role of CRT in node-positive patients. Clinicaltrials.gov identifier: NCT01032967.

Randomized, double-blinded, placebo-controlled trial of intravenously administered hyoscine N-butyl bromide in patients undergoing colonoscopy with patient-controlled sedation.

BACKGROUND A prospective, double-blinded, placebo-controlled randomized trial was conducted to investigate the effect of the antispasmodic hyoscine N-butyl bromide (Buscopan) during colonoscopy. METHODS A total of 120 patients undergoing colonoscopy were randomized to receive either 40 mg of hyoscine N-butyl bromide (n=60) or normal saline solution (n=60) intravenously as premedication. Colonoscopy was performed under patient-controlled sedation. Outcome measures included cecal intubation and total procedure time, demanded and administered doses of patient-controlled sedation, spasm score, pain score, endoscopist satisfaction score, patient willingness to repeat colonoscopy, and vital signs (blood pressure, pulse rate) during colonoscopy. RESULTS Mean cecal intubation time in the hyoscine N-butyl bromide group was significantly longer than the control group (12.20 vs. 9.74 minutes; p=0.04; but correction for multiple testing of data removed this significance). The use of hyoscine N-butyl bromide was associated with a significantly lower endoscopist mean satisfaction score (6.47 vs. 7.30; p=0.04; but correction for multiple testing of data removed this significance), higher demanded and administered mean doses of patient-controlled sedation (respectively, 34.80 and 7.25 vs. 24.20 and 5.87; p=0.045; p=0.04, respectively; but correction for multiple testing of data removed these findings of significance), fewer patients willing to repeat colonoscopy (60% vs. 83.9%; p=0.005), and more hemodynamic instability (p<0.001) when compared with the control group. No significant difference was found in the total procedure time, spasm score, or pain score. CONCLUSIONS Premedication with intravenously administered hyoscine N-butyl bromide impedes colonoscope insertion and causes greater patient discomfort, as well as hemodynamic instability.

Endoscopic balloon dilation for benign gastric outlet obstruction with or without Helicobacter pylori infection

BACKGROUND Endoscopic balloon dilation has been used to treat patients with gastric outlet obstruction caused by peptic stricture. This study assessed the role of endoscopic balloon dilation in patients with gastric outlet obstruction with or without Helicobacter pylori infection. METHODS Consecutive patients seen between January 1996 and September 2001 with benign gastric outlet obstruction (defined as stenosis preventing the passage of a 9-mm diameter endoscope, vomiting, succussion splash, and recent weight loss) were prospectively studied. Exclusion criteria were the following: refusal to undergo dilation, and gastric outlet obstruction because of malignancy. At endoscopy, antral biopsy specimens were obtained for histopathologic evaluation and for a rapid urease test for Helicobacter pylori infection. Patients then underwent dilation with through-the-scope balloons. After balloon dilation, patients with Helicobacter pylori infection were treated to eradicate the infection. RESULTS Fifty-one patients (33 men, 18 women; median age 65 years; IQR 44-79 years) were studied; 33 consented to endoscopic balloon dilation. Symptom resolution occurred in 25 patients (14 Helicobacter pylori positive, 11 Helicobacter pylori negative). During a median follow-up of 24 months (IQR 16-40 months), 3 of 14 patients in the Helicobacter pylori positive group and 6 of 11 in the Helicobacter pylori negative group developed further ulcer complications (p=0.039). CONCLUSIONS After endoscopic dilation for gastric outlet obstruction, eradication of Helicobacter pylori infection is associated with fewer ulcer complications.

OPTIMUM DURATION OF PROPHYLACTIC ANTIBIOTICS IN ACUTE NON‐PERFORATED APPENDICITIS

Background:  The effect of extended prophylactic antibiotic therapy on postoperative infective complications such as wound infection and intra‐abdominal abscess for non‐perforated appendicitis is poorly defined.