MILEPOST Multicenter Randomized Controlled Trial: 12-Month Weight Loss and Satiety Outcomes After pose SM vs. Medical Therapy.

BACKGROUND: Pose SM is an endolumenal weight-loss intervention in which suture anchors are placed endoscopically in the gastric fundus/distal gastric body. Observational studies of pose have shown safe, effective weight loss. Twelve-month results of a randomized controlled trial comparing weight loss and satiety after pose vs. conventional medical therapy are reported. METHODS: Subjects with classes I-II obesity were randomized in a 3:1 ratio to pose or diet/exercise guidance only (control). Pose subjects received gastric fundus and distal body suture-anchor plications with diet/exercise counseling. Total body (%TBWL) and excess weight loss (%EWL) were assessed at 6 and 12 months. Analysis of covariance (ANCOVA) was used to analyze 12-month %TBWL. Satiety changes were assessed at 6 and 12 months. RESULTS: From November 2013 to July 2014, 44 subjects were randomized (34, 77.3 % female; mean age, 38.3 ± 10.7 years; body mass index, 36.5 ± 3.4 kg/m2) to pose (n = 34) or control (n = 10) groups in three centers. Mean pose procedure time was 51.8 ± 14.5 min; pose subjects received a mean 8.8 ± 1.3 fundal and 4.2 ± 0.7 distal body plications. Twelve-month TBWL: pose, 13.0 % (EWL, 45.0 %), n = 30 vs. control group, 5.3 % (18.1 %), n = 9; significant mean difference, 7.7 % (95 % CI 2.2, 13.2; p < 0.01). Pose subjects showed significant reductions in satiety parameters (p < 0.001); controls experienced reduced caloric intake and satiety volume (p < 0.05). No serious device- or procedure-related adverse events occurred. CONCLUSIONS: In a randomized controlled trial at 12 months, pose-treated subjects had significantly greater weight loss than those treated with diet/exercise guidance alone. At 6 and 12 months, pose subjects showed significant reduction in satiety parameters. STUDY REGISTRATION: clinicaltrials.gov identifier # NCT01843231.

Gastrointestinal Physiological Changes and Their Relationship to Weight Loss Following the POSE Procedure.

BACKGROUND: Primary Obesity Surgery Endolumenal (POSE) is a novel bariatric endoscopic procedure that has been shown to reduce weight safely through 12 months. The study investigated potential mechanisms of weight loss following POSE. METHODS: Patients with class I-II obesity received transmural plications in the gastric fundus and distal gastric body. Patients were evaluated at baseline and at 2- and 6-month follow-up with gastric-emptying (GE) scintigraphy, a validated test of intake capacity (kcal) and plasma glucose homeostasis hormones/gastrointestinal peptides. Weight was recorded through 15 months. Mean data and 95% CIs are reported. Regression modeling assessed variables that influenced total weight loss (%TWL) and excess weight loss (%EWL). RESULTS: POSE was performed on 18 patients (14 F/4 M); mean age 39 years (34-44), body mass index (BMI, kg/m(2)) 36 (95% CI, 35; 37). At 15 months (n = 15), mean TWL was 19.1 ± 6.6% (15.5; 22.8) and EWL was 63.7 ± 25.1% (49.8; 77.6). At 2 and 6 months (n = 18), intake capacity decreased significantly from 901 (685; 1117) to 473 (345; 600) and 574 kcal (418; 730), respectively (p < 0.001). At 2 months, GE was delayed but returned to baseline levels at 6 months (n = 18). Glucose/insulin ratio improved (p < 0.05). Postprandial decrease in ghrelin was enhanced (p = 0.03) as well as postprandial increase in PYY (p = 0.001). The best model for EWL prediction 15 months after POSE (R (2): 66%, p = 0.006) included pre-POSE BMI, post-POSE GE, and postprandial PYY increase. CONCLUSIONS: The POSE procedure was followed by significant sustained weight loss and improved glucose homeostasis and satiation peptide responses. Weight loss following POSE may be mediated through changes in gastrointestinal neuro-endocrine physiology.

Early experience with the Incisionless Operating Platform™ (IOP) for the treatment of obesity : the Primary Obesity Surgery Endolumenal (POSE) procedure.

BACKGROUND: We report our initial experience and 6-month outcomes in a single center using the per-oral Incisionless Operating Platform™ (IOP) (USGI Medical) to place transmural plications in the gastric fundus and distal body using specialized suture anchors (the Primary Obesity Surgery Endolumenal [POSE] procedure). METHODS: A prospective observational study was undertaken with institutional Ethics Board approval in a private hospital in Barcelona, Spain. Indicated patients were WHO obesity class I-II, or III, where patients refused a surgical approach. RESULTS: Between February 28, 2011 and March 23, 2012, the POSE procedure was successfully performed in 45 patients: 75.6 % female; mean age 43.4 ± 9.2 SD (range 21.0-64.0). At baseline: mean absolute weight (AW, kg), 100.8 ± 12.9 (75.5-132.5); body mass index (BMI, kg/m(2)), 36.7 ± 3.8 (28.1-46.6). A mean 8.2 suture-anchor plications were placed in the fundus, 3.0 along the distal body wall. Mean operative time, 69.2 ± 26.6 min (32.0-126.0); patients were discharged in <24 h. Six-month mean AW was 87.0 ± 10.3 (68.0-111.5); BMI decreased 5.8 to 31.3 ± 3.3 (25.1-38.6) (p < 0.001); EWL was 49.4 %; TBWL, 15.5 %. No mortality or operative morbidity. Minor postoperative side effects resolved with treatment by discharge. Patients reported less hunger and earlier satiety post procedure. Liquid intake began 12 h post procedure with full solids by 6 weeks. CONCLUSIONS: At 6-month follow-up of a prospective case series, the POSE procedure appeared to provide safe and effective weight loss without the scarring, pain, and recovery issues of open and laparoscopic bariatric surgery. Long-term follow-up and further study are required.

Endoscopic treatment with self-expanding metal stents for Crohn's disease strictures.

BACKGROUND: Balloon dilation (with or without steroid injection) is the endoscopic treatment of choice for short strictures in Crohn's disease (CD). The placement of a stent has only rarely been reported in this setting, and it may be a good alternative. AIM: To describe the efficacy of temporary placement of a self-expanding metallic stent (SEMS) in the endoscopic treatment of symptomatic strictures in CD. METHODS: We included 17 CD patients treated with SEMS (4 partially covered SEMS and 21 fully covered SEMS) for symptomatic strictures refractory to medical and/or endoscopic treatment. RESULTS: We placed 25 stents in 17 patients with stenosis (<8 cm), in the colon and in the ileocolonic anastomosis. In two cases, two stents were placed in the same endoscopic procedure. All except three cases had previously been unsuccessfully treated with endoscopic dilatation. The stents were maintained for an average of 28 days (1­112). The treatment was effective in 64.7% of the patients after a mean follow-up time of 60 weeks (5­266). In four cases, removal of the stents was technically difficult due to stent impaction (moderate adverse events-AEs) and one patient had a proximal stent migration requiring delayed surgery (severe AE). CONCLUSION: The placement of self-expanding metallic stent in Crohn's disease maintained over a period of 4 weeks is a safe, effective treatment for strictures refractory to medical treatment and/or balloon dilatation, and might be an alternative endoscopic

Usefulness of endoscopic ultrasonography (EUS) for selecting carcinoid tumors as candidates to endoscopic resection.

INTRODUCTION: Carcinoid tumors (CTs) represent the most common type of neuroendocrine tumors (NETs). Digestive CTs in the gastroduodenal and colorectal tracts may be assessed using endoscopy and echoendoscopy or endoscopic ultrasonography (EUS) with the goal of attempting local resection with curative intent without having recourse to surgery. OBJECTIVE: Endpoints in this study included:--Assessing the usefulness of EUS for selecting CTs as candidates to endoscopic excision. --Assessing the effectiveness of local resection (complete carcinoid resection) and the safety (complications) of the technique involved. PATIENTS AND METHODS: OUr series included 18 patients (12 males and 6 females) with 23 tumors. Sixteen patients (10 males and 6 females) were selected, with age ranging from 40 to 81 years (mean: 57 years), biopsied, endoscopically treated digestive carcinoid tumors, and a previous negative extension study. Twenty-one 2-to-20-mm (mean size 8 mm) tumors were resected in 23 procedures. After endoscopy plus biopsy and echoendoscopy (EUS), excision was carried out with conventional polypectomy snare mucosectomy and submucosal injection with saline and/or adrenaline in most cases (15), and mucosectomy technique following lesion ligation with elastic bands for six cases. Two cases underwent transanal endoscopic surgery (TEM), one of them following non-curative polypectomy. A total of 23 local procedures were performed with the key goal of assessing efficacy (complete resection: CR) and safety (complications). RESULTS: There were no severe complications except for the last gastric mucosectomy for a 6-mm carcinoid, where a miniperforation occurred that was solved by using 3 clips (1/23: 4.3%).EUS sensitivity was 94%. Complete resection was 90.5% (19/21). CONCLUSIONS: The endoscopic mucosal resection of selected carcinoid tumors is a safe, effective technique. EUS is the technique of choice to select patients eligible for endoscopic resection (carcinoids smaller than 20 mm in superficial layers, with an unscathed muscularis propria and negative extension study).

[Interventionist endoscopic ultrasonography. A retrospective analysis of 60 procedures]. / Ultrasonografía endoscópica intervencionista. Análisis retrospectivo de 60 procedimientos.

INTRODUCTION AND OBJECTIVE: interventionist endoscopic ultrasonography is increasingly used because of its growing indications. We present here our retrospective and initial experience (60 procedures) with endoscopic ultrasonography (EUS) both for diagnosis (EUS-FNA) and therapy (EUS-guided tumorectomy and mucosectomy). PATIENTS AND METHOD: in a group with 27 cases including 10 submucosal tumors (SMTs), 2 adenopathies, and 15 potential pancreatic tumors (8 pancreatic cancers), a sectorial EUS-FNA at 7.5 MHz was performed for diagnosis prior to therapy (mainly surgical). A pancreatic pseudocyst was drained. In 21 cases with 27 SMTs (10 patients with 13 carcinoids) a tumorectomy was carried out using the standard loop or assisted polypectomy technique with submucosal injection, and in a few cases (two) using elastic band ligation following a radial EUS at 7.5, 12, or 20 MHz. In 6 cases of superficial gastroesophageal cancer or gastric dysplasia an endoscopic mucosal resection (classic EMR) was performed after EUS or MPs at 7.5 and 20 MHz. Fifty-five patients with 60 lesions, 29 femaes and 26 males with a mean age of 60 years (30-88 years) were retrospectively analyzed. RESULTS: diagnostic precision (P), sensitivity (S), specificity (Sp), positive predictive value (PPV), and negative predictive value (NPV) for EUS-FNA was 85, 83, 100, 100, and 43%, respectively, when comparing results with specimen histology. P was higher for adenopathies (100%) and pancreatic tumors (87%) than for SMTs (80%). No complications arose, except for one episode of upper gastrointestinal bleeding (UGIB) (3.7%) that was endoscopically and satisfactorily treated in a gastric SMT. In the group with 21 patients (10 carcinoids with 13 tumors) 27 SMTs were endoscopically treated by tumorectomy with no perforation and only 2 UGIBs (7.4%), one of them self-limited, recorded. Endoscopic resection was complete in 92% of cases. No complications occurred with classic EMR, and all patients are still alive with no evidence of relapse, either local or metastatic. In this group the rate of complete resections was 100%. CONCLUSIONS: EUS-FNA is a safe technique with high diagnostic accuracy. EUS-guided tumorectomy and mucosectomy are also safe and effective techniques in the endoscopic management of these tumors.

Endoscopic staging of low-grade gastric MALT lymphoma.

INTRODUCTION: Endoscopic ultrasonography (EUS) has already proven useful in the assessment of submucosal lesions, and the staging of gastrointestinal cancer, particularly gastric MALT-type lymphoma. The goal of this paper was EUS staging. PATIENTS AND METHOD: 24 patients (10 females, 14 males) with a median age of 56 years and possibly gastric MALT lymphoma (25 cases) were studied using videoendoscopy, biopsies, and echoendoscopy with 7.5- and 20-MHz radial EUS, and also with 12- and 20-MHz miniprobes (MPs). Nineteen patients were definitely evaluated (7 females, 12 males) as having 20 MALT-type lymphomas, as five patients were post-hoc disregarded when an invasive, high-grade gastric lymphoma (3c) or plasmocytoma (2c) was subsequently demonstrated. Of these 19 patients, all had T1 lesions except for two with T2 lesions; one patient had a gastroduodenal T1 lymphoma. Echographic findings with MPs were compared to EUS (gold standard) and histology both before and after eradication. Then, patients were followed up every 1-3-6 months using videoendoscopy and MPs. RESULTS: Echoendoscopy correctly identified T stages in 90% of cases. MPs identified T stages in 88% of cases, and N stages in 33% of cases, with results being slightly inferior to those obtained with conventional EUS (91 vs. 45%); they were consequently used for follow-up. After eradication, all but two patients are in complete remission and have been followed every 1-3-6 months using MPs without echographic abnormalities, except for a patient who relapsed.

Spectrum of gluten-sensitive enteropathy in first-degree relatives of patients with coeliac disease: clinical relevance of lymphocytic enteritis.

BACKGROUND: Limited data on a short series of patients suggest that lymphocytic enteritis (classically considered as latent coeliac disease) may produce symptoms of malabsorption, although the true prevalence of this situation is unknown. Serological markers of coeliac disease are of little diagnostic value in identifying these patients. AIMS: To evaluate the usefulness of human leucocyte antigen-DQ2 genotyping followed by duodenal biopsy for the detection of gluten-sensitive enteropathy in first-degree relatives of patients with coeliac disease and to assess the clinical relevance of lymphocytic enteritis diagnosed with this screening strategy. PATIENTS AND METHODS: 221 first-degree relatives of 82 DQ2+ patients with coeliac disease were consecutively included. Duodenal biopsy (for histological examination and tissue transglutaminase antibody assay in culture supernatant) was carried out on all DQ2+ relatives. Clinical features, biochemical parameters and bone mineral density were recorded. RESULTS: 130 relatives (58.8%) were DQ2+, showing the following histological stages: 64 (49.2%) Marsh 0; 32 (24.6%) Marsh I; 1 (0.8%) Marsh II; 13 (10.0%) Marsh III; 15.4% refused the biopsy. 49 relatives showed gluten sensitive enteropathy, 46 with histological abnormalities and 3 with Marsh 0 but positive tissue transglutaminase antibody in culture supernatant. Only 17 of 221 relatives had positive serological markers. Differences in the diagnostic yield between the proposed strategy and serology were significant (22.2% v 7.2%, p<0.001). Relatives with Marsh I and Marsh II-III were more often symptomatic (56.3% and 53.8%, respectively) than relatives with normal mucosa (21.1%; p = 0.002). Marsh I relatives had more severe abdominal pain (p = 0.006), severe distension (p = 0.047) and anaemia (p = 0.038) than those with Marsh 0. The prevalence of abnormal bone mineral density was similar in relatives with Marsh I (37%) and Marsh III (44.4%). CONCLUSIONS: The high number of symptomatic patients with lymphocytic enteritis (Marsh I) supports the need for a strategy based on human leucocyte antigen-DQ2 genotyping followed by duodenal biopsy in relatives of patients with coeliac disease and modifies the current concept that villous atrophy is required to prescribe a gluten-free diet.

Our cumulative experience with transendoscopic miniprobes.

INTRODUCTION: Transendoscopic miniprobes (TEMPs) have nowadays precise indications, but may become a diagnostic alternative to both radial and sectorial endoscopic ultrasonography (EUS) in the near future. PATIENTS AND METHODS: From November 1996 to July 2004 we carried out 620 examinations using TEMPs (124 during the last 12 months in 2003, with currently a mean of 11 examinations/month). Twenty explorations were performed with radial, 12.5 MHz (20 mm penetration), 6.2 F (2 mm diameter), 950 mm or 2000 mm Microvasive Endosound probes. Twenty explorations were performed using a 12 MHz (29 mm mean penetration) or 20 MHz (18 mm penetration) Olympus UM-2R/3R, or with a 12 MHz UM-DP12-25R or 20 MHz UM-DP20-25 R DPR-fitted Olympus probe, 2.5 mm in diameter and 2050 mm in length. A 20 MHz, 2.2 mm, wire-guided G20-29R was used for intraductal studies. In all, 580 examinations were carried out with both radial and linear, 12 MHz (240 E) or 20 MHz (60 E) Fuji probes, 2.6 mm in diameter and 1900 mm in length; and with a 7.5 MHz, 2.6 mm radial balloon microprobe with the well-known "preload" system that we have been using during the 1999-2004 period (280 E). Here we used a 3.2 mm working channel, whereas a 2.8 mm working channel was used with the remaining TEMPs. RESULTS: Twenty GI-tract examinations were performed with one Microvasive probe, which broke down when attempting its passage through the papilla. Currently we use a 20 MHz, 2.2 mm Olympus G20-29R guided microprobe for intraductal studies. We performed 100 gut examinations using one single Fuji TEMP (12 or 7.5 MHz). Organs explored included: esophagus and stomach, 60%; rectum and colon, 30%; other (duodenum, papilla, bile ducts), 10%. INDICATIONS: cancer staging, 35%; submucosal lesions, 30%; other, 35% (including 20% of esophageal non-tumoral conditions). COMPLICATIONS: aspiration, perforation, and mortality, 0%. Morbidity, 10%, at the expense of abdominal pain as induced by endoscopy itself. All strictures were successfully passed, except for one malignant stenosis in the rectum. CONCLUSIONS: During a 93-month period (1996-2004) we performed 620 explorations with TEMPs, with a current average of 11 examinations/month. TEMP durability is around 100 gut explorations. The esophagus and stomach were examined in 60% of cases. Primary indications included gut cancer staging and submucosal lesions (65%). Perforation and mortality rates amounted to 0%.

Emergency laparoscopic treatment for acute massive bleeding of an esophageal ulcer.

Laparoscopic fundoplication is now considered the treatment of choice for the management of severe gastroesophageal reflux disease (GERD) and its complications. The laparoscopic approach achieves the same good results as open surgery in elective surgery for GERD; it also has all the advantages of minimally invasive surgery. Today, laparoscopy plays also a significant role in a great variety of emergency abdominal situations and acute abdominal pain. A 30-year-old man was admitted to our center due to an upper gastrointestinal bleed caused by a esophageal ulcer over a Barrett's esophagus located in lower third of the esophagus. Two therapeutic esophagogastroscopies were done in 24 h, but urgent surgical intervention was indicated because of recurrent transfusion-demanding bleeding. A combined laparoscopic-endoscopic approach was followed. Surgery began with a complete hiatal dissection, including the distal third of the esophagus, diaphragmatic crus, and wide retrogastric window. Intraoperative flexible esophagoscopy revealed an active ulcer bleeding on the right anterior quadrant in the lower esophagus. Two transfixive stitches were applied through the wall of the esophagus at the site indicated by the light of the flexible endoscope, and complete hemostasis was achieved. Finally, employing the anterior wall of the fundus, a short Nissen-Rossetti fundoplication was performed. The operating time was 140 min. There were no complications and there has been no recurrence of the bleeding.

Bile acid malabsorption in microscopic colitis and in previously unexplained functional chronic diarrhea.

Bile acid malabsorption (BAM) has been described in patients with collagenous colitis. There are no similar studies in lymphocytic colitis. The possibility that BAM might not necessarily be part of the microscopic colitis process and that both entities could simply be concomitant has not been evaluated. Our aim was to assess the frequency and severity of BAM in patients with microscopic colitis as well as in patients with previously unexplained functional chronic diarrhea. Likewise, we wanted to investigate the effect of cholestyramine on the induction and maintenance of remission of these conditions. A [75Se]HCAT abdominal retention test was performed in 26 patients with collagenous colitis, 25 with lymphocytic colitis, and 32 with previously unexplained functional chronic diarrhea. Patients with microscopic colitis who had BAM as well as a subgroup of eight collagenous colitis patients without BAM received treatment with cholestyramine. All patients with previously unexplained chronic diarrhea who had BAM were treated with cholestyramine. Twenty-two (43.1%) patients with microscopic colitis and 24 (75%) patients with previously unexplained functional chronic diarrhea presented with BAM. The frequency of BAM was higher in lymphocytic colitis than in collagenous colitis (60% vs 27%; P = 0.025). Cholestyramine induced clinical remission in 19 of 22 patients with microscopic colitis and BAM, none of eight patients with collagenous colitis without BAM, and all patients with previously unexplained chronic diarrhea and BAM. In conclusion, BAM seems to be common in patients with microscopic colitis-mainly in lymphocytic colitis-and in those with previously unexplained functional chronic diarrhea, suggesting that idiopathic BAM and microscopic colitis are often concomitant conditions. In this setting, cholestyramine seems to be highly effective in stopping diarrhea.

Accuracy of an enzyme immunoassay for the detection of Helicobacter pylori in stool specimens in the diagnosis of infection and posttreatment check-up.

OBJECTIVE: The aim of this study was to assess the reliability of a newly developed enzyme immunoassay for Helicobacter pylori-specific antigen detection in stools (HpSA) compared to other standardized diagnostic techniques such as histology (H), rapid urease test (RUT) and 13C-urea breath test (UBT) to diagnose H. pylori infection and to evaluate its usefulness in determining H. pylori status after treatment. METHODS: One hundred eighty-eight patients referred to our department for upper gastrointestinal endoscopy were included. H. pylori infection was confirmed in all patients by HpSA test in stools, RUT, UBT, and H. Patients were defined as positive for H. pylori if RUT and UBT or H were positive. A total of 142 symptomatic patients received eradication treatment and were reassessed 6 wk after therapy; for 70 of these patients, stool samples were also collected at 24 h and 6 months after finishing eradication treatment. In the posttreatment follow-up, UBT was used as gold standard. RESULTS: The sensitivity of HpSA test for the diagnosis of H. pylori infection using a cut-off value of 0.130 was 89.5% and its specificity 77.8%. This specificity was lower than that obtained with UBT, H, and RUT. In the early follow-up the sensitivity of HpSA test was null. At 6 weeks and at 6 months post-treatment its sensitivity was 70.4% and 50% and its specificity was 81.6% and 79.3%, respectively. CONCLUSIONS: The HpSA stool test, using a cut-off value of 0.130, may be useful for the primary diagnosis of H. pylori infection, with sensitivity similar to that obtained with other standard tests, but with less specificity. HpSA test is not useful for early monitoring of treatment efficacy. At 6 wk and at 6 months posttreatment, HpSA test lacks accuracy as compared to UBT for evaluating the outcome of the eradication treatment.

[The value of endoscopic ultrasonography in the study of submucosal tumors of the digestive tract]. / Valor de la ultrasonografía endoscópica en el estudio de los tumores submucosos del tracto digestivo.

Twenty-one consecutive patients with 24 possible submucosal lesions of the digestive tract were studied. Endoscopic ultrasonography (EUS) differentiated between 17 true positive submucosal tumors and 3 true negative extrinsic compressions. False positives were interpreted in 3 cases and in one patient no lesion was echoendoscopically observed (false negative). The sensitivity was 94%, the specificity 50% and the positive and negative predictive values were 82% and 75%, respectively. In conclusion, EUS may be the method of choice for the study of submucosal tumors since it allows visualization of the five layers of the wall of the digestive tract in which a tumor may originate, determination of its sonographic features, depth and exact size, in addition to the invasion of neighboring organs. Moreover, EUS may aid in collecting material for cytology and microscopy by fine needle aspiration puncture (FNAP) by EUS.

Randomized clinical trial comparing two one-week triple-therapy regimens for the eradication of Helicobacter pylori infection and duodenal ulcer healing.

OBJECTIVE: One-week triple therapy has been shown to be effective in Helicobacter pylori eradication and duodenal ulcer healing. However, the optimal therapeutic combination has not yet been identified. Bismuth-containing regimens have the advantage of requiring only one antibiotic. It has been suggested that high doses of omeprazole improve the bactericidal efficacy of antimicrobial regimens against H. pylori. We evaluated the efficacy of two 1-wk triple-therapy regimens for H. pylori eradication and duodenal ulcer healing. METHODS: On an intention-to-treat basis, 182 patients with H. pylori-associated duodenal ulcer were randomized. Group OCB patients (n = 91) were given omeprazole 40 mg b.i.d., clarithromycin 500 mg b.i.d., and colloidal bismuth subcitrate 120 mg q.i.d. for 7 days. Group OCA patients (n = 91) were treated with omeprazole and clarithromycin at the same doses plus amoxicillin 1 g b.i.d., also for 7 days. Endoscopies were performed at entry and at 4 wk after the end of treatment. The presence of H. pylori was assessed by urease test, histology, Gram stain, and culture. No patient received follow-up treatment. RESULTS: H. pylori eradication rates achieved in the OCB and OCA groups were similar whether by intention-to-treat (82.4% vs 88.9% ;p = 0.21) or per protocol analysis (83.3% vs 89.9%; p = 0.19). Duodenal ulcer healing rates also were the same for OCB and OCA in intention-to treat (91.2% vs 91.1%) and per protocol analysis (92.2% vs 92.1%), respectively (p = 0.98). CONCLUSIONS: High rates of H. pylori eradication and duodenal ulcer healing were obtained with both short-treatment regimens, which were safe and well-tolerated. Colloidal bismuth subcitrate seems to be a good alternative to amoxicillin in the triple-therapy combination with omeprazole and clarithromycin. The omeprazole dose does not seem to play a major role in H. pylori eradication in these therapeutic combinations.

Impact of colloidal bismuth subnitrate in the eradication rates of Helicobacter pylori infection-associated duodenal ulcer using a short treatment regimen with omeprazole and clarithromycin: a randomized study.

UNLABELLED: Recent trials have shown that duodenal ulcers treated by H2-blockers heal faster if Helicobacter pylori is eradicated concurrently. OBJECTIVES: To evaluate the efficacy of a short treatment regimen in H. pylori eradication and ulcer healing and to assess the impact of colloidal bismuth subnitrate (CBS) in H. pylori eradication rate. METHODS: Sixty-one patients with H. pylori-associated duodenal ulcer were randomized in two short treatment groups. Group A patients (31) were given omeprazole 20 mg b.i.d. x 8 days. Clarithromycin (500 mg, b.i.d.) and CBS (120 mg, q.i.d.) were added 24 h after starting omeprazole and were given for 7 days. Group B patients (30) were treated as group A patients but without CBS. Endoscopies were performed at entry and 4 wk after the end of treatment. Presence of H. pylori was assessed at each endoscopy by urease test, and biopsy specimens were examined for histological evidence of gastritis and by Gram stain and culture for H. pylori infection. No patient received follow-up treatment. RESULTS: H. pylori eradication rates were achieved in 25/31 (80.6%) group A patients and in 15/30 (50%) in group B patients (p = 0.012). Duodenal ulcer healing was documented in 30/31 (96.8%) patients in group A and in 25/30 (83%) patients in group B. CONCLUSIONS: The addition of CBS to the double therapy with omeprazole and clarithromycin substantially improves the eradication rate of H. pylori. Short therapy with omeprazole 20 mg/b.i.d., clarithromycin 500 mg/b.i.d., and CBS 120 mg/q.i.d. is a safe, well tolerated combination that achieves a 80.6% eradication rate of H. pylori and duodenal ulcer healing rates as good as those achieved by omeprazole 20 mg/d when given for 4 wk.

[The endoscopic treatment of postcholecystectomy biliary leakage]. / Tratamiento endoscópico de la fuga biliar poscolecistectomía.

Although there is a decrease in the total number of complications observed on performance of laparoscopy cholecystectomy (LC) there does appear to be an increase in biliary tract lesions. Seven cases of postcholecystectomy biliary leakage treated with endoscopic methods are presented. These cases include 4 patients with leakage from the cystic canal stump and 3 with leakage from the common bile duct. In 5 cases the biliary tract lesion occurred following LC, 1 after conventional cholecystectomy and in 1 reconverted LP. CPRE identified the site of the leakage in the 7 patients and in 2 residual choledocholithiasis. In 5 cases treatment consisted in endoscopic papillotomy and placement of biliary endoprosthesis while only papillotomy was performed in 2 patients. In one of these cases CPRE was repeated and the sphincterotomy widened due to persistence of the leakage at 5 days, with the same finally closing at 15 days of the second CPRE. Closure of the biliary leakage was obtained in the other 6 cases in less than 72 hours post-CPRE. No complications secondary to the technique were observed. It was concluded that CPRE together with endoscopic papillotomy and placement of biliary prostheses is an effective and safe treatment for postcholecystectomy biliary leakages of the common bile duct or cystic duct.

[Percutaneous endoscopic gastrostomy: study on 35 patients]. / Gastrostomía endoscópica percutánea: estudio de 35 enfermos.

BACKGROUND: A review of the technique, indications, complications and follow up of percutaneous endoscopic gastrostomy (PEG) was performed. METHODS: Thirty-five patients in whom a PEG had been placed according to the Ponsky technique from 1991 to 1993 were analyzed 27 of whom had neurologic disease, 6 tumoral diseases and 2 other causes. RESULTS: PEG was carried out in 33 patients with no incidences while the technique could not be performed in 2 since the point could not be identified by transillumination in the gastric wall. No immediate complications were observed. Seven minor early complications were presented as wound infection with the cannula being withdrawn in only one case due to persistence of the infection. Five late complications were reported: 1 severe (gastrocholic fistula) and 4 minor (2 cannula obstructions, 1 displacement and 1 infection). Evolution was followed in 31 patients with the cannula being withdrawn in 4 (2 because of complications and in the other 2 on initiation of oral diet). The cannula was substituted at 120 and 360 days in 2 patients. Sixteen patients died, 5 during the first 30 days due to the primary disease, with only one case (aspirative pneumonia) being related to the PEG. The PEG continues functioning in 11 patients. CONCLUSIONS: Percutaneous endoscopic gastrostomy for feeding is a simple technique which may be carried out in most patients with scarce severe complications, allowing a good nutritional state and improving the quality of life of patients requiring prolonged enteral feeding.