Sucralfate or placebo following argon plasma coagulation for chronic radiation proctitis: a randomized double blind trial.

AIM: Chronic radiation proctitis is a long-term complication of radiation therapy for pelvic malignancy. The aim of this study was to compare the efficacy and safety of two treatment regimens, sucralfate or placebo, following argon plasma coagulation (APC) for chronic haemorrhagic radiation proctitis. METHOD: A single-centre, randomized, placebo-controlled, double-blind study was performed on patients with haemorrhagic chronic radiation proctitis after irradiation for prostate, uterine, cervical, rectal or vaginal cancer. All patients received APC, and were then randomized to oral sucralfate (6 g twice a day) or placebo treatment for 4 weeks. APC was repeated every 8 weeks if necessary after the first session. Patients were graded clinically and endoscopically according to the Chutkan and Gilinski scales before and at 8 and 16 weeks after initial APC treatment (1.5-2 l/min, 25-40 W) and after 52 weeks (clinical only). RESULTS: Of 122 patients, 117 completed the entire protocol, with 57/60 in the sucralfate group and 60/62 in the placebo group. At baseline there were no significant differences between the sucralfate and placebo groups. At 1 year, a significant improvement in the clinical scale in both groups occurred compared with baseline. After 16 weeks, the median overall clinical severity scores fell from 4 to 2 points and the median bleeding score from 2 to 0 in both groups. CONCLUSION: APC is safe and effective for the management of chronic radiation proctitis. Additional sucralfate treatment did not influence the clinical or endoscopic outcome.

Diagnostic yield and safety of endoscopic ultrasound-guided trucut [corrected] biopsy in patients with gastric submucosal tumors: a prospective study.

BACKGROUND AND STUDY AIMS: Endoscopic-ultrasound-guided trucut needle biopsy (EUS-TCB) has not been adequately evaluated in patients with submucosal tumors (SMTs). PATIENTS AND METHODS: This prospective, uncontrolled study involving 49 consecutive patients with hypoechoic gastric SMTs (> or = 20 mm) evaluated diagnostic yield and 30-day morbidity of EUS-TCB, factors related to the success of EUS-TCB, and agreement between EUS-TCB and the surgical pathology diagnosis. Seventy-three percent of tumors were gastrointestinal stromal tumors (GIST). RESULTS: Tumor tissue adequate for diagnosis was obtained by EUS-TCB in 31 patients (63 %; 95 %CI 49 % to 75 %). In the remaining cases, EUS-TCB provided no tissue (n = 11) or an insufficient amount (n = 7). Logistic regression analysis showed that tumor location on the lesser curvature of the stomach was the only independent predictor of obtaining diagnostic material [odds ratio (OR) 7.4; 95 %CI 1.9 to 28; P = 0.004]. The experience of the endosonographer, the size of the tumor, and the location of the tumor relative to the long axis of the stomach were not related to the success of the biopsy. Agreement between EUS-TCB and surgical pathology specimens in respect of the diagnosis and CD117 status was high (0.9, standard error 0.31; and 0.95, standard error 0.16, respectively); however, there was no correlation between the mitotic index as determined on EUS-TCB and that determined on the surgical pathology specimen (correlation coefficient, 0.08). There were two severe septic complications in 52 procedures (3.9 %; 95 %CI 0.3 % to 14 %). CONCLUSIONS: The diagnostic yield of EUS-TCB in patients with gastric SMTs was moderate. Tissue samples were too small to reliably determine the mitotic index. Antibiotic prophylaxis should be considered because of possible septic complications.

Endoscopic ultrasound versus endoscopic retrograde cholangiography for patients with intermediate probability of bile duct stones: a randomized trial comparing two management strategies.

BACKGROUND AND STUDY AIMS: Diagnostic endoscopic retrograde cholangiography (ERC) is being replaced by endoscopic ultrasonography (EUS) in patients with suspected bile duct stones. The assumption that such an approach is advantageous, however, has never been tested in a randomized trial. PATIENTS AND METHODS: 100 patients with intermediate probability of bile duct stones were randomly allocated to EUS or ERC. Two patients in the ERC group were excluded; the remaining 98 patients received the allocated intervention and were entered into the analysis (EUS, 50 patients; ERC, 48 patients). Detected stones were removed endoscopically; patients without stones were followed for 1 year. The primary end point was the proportion of patients with a negative outcome, related to either endoscopic procedures (complications) or to false-negative diagnosis of stones. Investigators assessing the negative outcomes were not blinded to group assignment. The secondary end point was the total number of endoscopic procedures (EUS and ERC) performed in each group to diagnose and treat stones. RESULTS: Bile duct stone prevalence was 28% and 25% in the EUS and ERC groups, respectively (P > 0.05). In the EUS group, 71 endoscopic procedures were performed, and 63 in the ERC group (mean per patient, 1.42 +/- 0.76, and 1.31 +/- 0.55, respectively; P > 0.05). In the EUS group, these included 49 successful and one failed initial EUS, 15 ERCs for bile duct stone treatment, and six procedures required during follow-up. In the ERC group there were 36 successful and 12 failed initial ERCs, 13 repeat procedures (EUS or ERC) performed after failed or equivocal initial ERC, and two procedures during follow-up. Five patients in the EUS group (10%, 95% CI 4-22) and 19 patients in the ERC group (40%, 95% CI 27-54) experienced a negative outcome (P < 0.001). No difference was observed when only moderate to severe complications were considered (6%, 95% CI 1-17, and 10%, 95% CI 4-23, respectively). CONCLUSIONS: In patients with intermediate probability of bile duct stones, the management strategy based on EUS (with selective ERC in patients with confirmed stones) is safer and not associated with an excess of endoscopic procedures compared with a strategy based on ERC alone.

Diffuse nodular lymphoid hyperplasia of the gastrointestinal tract in patient with selective immunoglobulin A deficiency and sarcoid-like syndrome--case report.

Nodular lymphoid hyperplasia is uncommon in adult patients. Associated diseases are common variable immunodeficiency (CVI) and lymphoid tissue malignancies. In this case report we focus on clinical presentation and differential diagnosis of diffuse nodular lymphoid hyperplasia of the gastrointestinal tract coexisting with selective immunoglobulin A deficiency and sarcoid-like syndrome.

Endosonography versus helical computed tomography for locoregional staging of gastric cancer.

BACKGROUND AND STUDY AIMS: Endosonography (EUS) has been shown to be more accurate than incremental computed tomography (CT) in the local (T) and regional (N) staging of gastric carcinoma; however, EUS has never been compared with helical CT (HCT). The fifth edition of the TNM classification changed the guidelines for N-staging of gastric carcinoma. The accuracy of imaging methods in this new system remains unknown. PATIENTS AND METHODS: Staging accuracy of EUS and HCT were compared prospectively with pathological or intraoperative findings in 88 gastric carcinoma patients. Staging was done according to the fourth and fifth editions of the TNM classification. EUS was done with a radial echo endoscope, and HCT with a scanner with two rows of detectors (two-phase contrast-enhanced scanning of a water-filled stomach). RESULTS: The T-staging accuracy of EUS (63 %, CI 52 - 73 %) was superior to the accuracy of HCT (44 %, CI 34 - 55 %; P = 0.021). N-staging accuracy of both methods was similar when the fourth edition of the TNM classification was used (EUS 47 %, CI 34 - 60 %; HCT 52 %, CI 38 - 65 %). However, HCT was more accurate than EUS when the fifth edition of the classification was applied (EUS 30 %, CI 18 - 43 %, HCT 47 %, CI 34 - 60 %; P = 0.044). The accuracy of detection of lymph node metastases was similar for both methods (EUS 67 %, CI 54 - 78 %; HCT 77 %, CI 64 - 86 %). CONCLUSIONS: EUS is more accurate than HCT in the T-staging of gastric carcinoma. Both methods are comparable for N-staging, when this is done according to the older, fourth edition of the TNM classification. If the fifth edition is used, EUS is less accurate than HCT.

Endoscopic ultrasonography for prediction of postpolypectomy bleeding in patients with large nonpedunculated rectosigmoid adenomas.

BACKGROUND AND STUDY AIMS: Case reports suggest that endosonographic visualization of blood vessels in a gastric polyp may be predictive of risk of postpolypectomy bleeding; however, this issue has never been studied in patients with colorectal adenomas. PATIENTS AND METHODS: Endosonography (EUS) was performed prior to endoscopic polypectomy of 42 large (>/= 20 mm) nonpedunculated adenomatous polyps. The median diameter of the polyps was 30 mm (range 20-100 mm); 35 were located in the rectum and seven in the sigmoid colon. During EUS both the polyp and the bowel wall underneath were searched for the presence of vessels, which were defined as longitudinal/tortuous or round/oval echo-free structures >/= 2 mm in diameter. RESULTS: The polyp was visualized adequately in 39 cases; three cases were excluded from analysis due to inadequate visualization. In eight polyps (20.5%, group 1) EUS revealed vessels measuring 2-4 mm; in 31 polyps (79.5 %, group 2) no vessels were found. The postpolypectomy bleeding incidence (per polyp treated) was 12.5% in group 1 and 12.9 % in group 2 (P>0.05). CONCLUSIONS: In this small series of patients with large nonpedunculated rectosigmoid adenomas, the EUS image of the polyp was not predictive of postpolypectomy bleeding. The detection of vessels on EUS did not increase the risk for bleeding; however, the sample size was to small to draw definite conclusions. The absence of vessels on EUS did not rule out the possibility of bleeding.

Argon plasma coagulation after piecemeal polypectomy of sessile colorectal adenomas: long-term follow-up study.

BACKGROUND AND STUDY AIMS: The aim of this study was to evaluate prospectively the long-term outcomes of using argon plasma coagulation (APC) as an adjunct to piecemeal polypectomy of large sessile colorectal adenomas. PATIENTS AND METHODS: A total of 77 patients with 82 sessile colorectal adenomas (median size 2.9 cm, range 1.5 - 8.0 cm) underwent snare piecemeal polypectomy. Patients in whom polypectomy was complete received no further treatment (polypectomy group; n = 14). When polypectomy was incomplete, additional treatment with APC was started either immediately or 1 - 3 months after the last polypectomy session (polypectomy + APC group; n = 63). Patients were followed (by endoscopy and biopsy) at regular intervals. RESULTS: Histologically proven adenoma eradication was achieved in 100 % of patients (14/14) in the polypectomy group and in 90 % of patients (57/63) in the polypectomy + APC group (two patients died of unrelated causes before adenoma was eradicated, two underwent operation because cancer was detected in the polyp treated, and two underwent operation because of endoscopic treatment failure). The adenoma recurrence rate was 14 % in both the polypectomy and polypectomy + APC groups. All recurrences except one occurred during the first year of follow-up and all were successfully re-treated endoscopically. A total of 69 patients in whom long-term follow-up data are available are free from adenoma at a median follow-up of 37 months (range 12 - 80). No major complications of endoscopic treatment occurred. In seven cases (9 %) the polyp was eventually shown to be malignant; in two of these patients the diagnosis of cancer was delayed as a result of unsuccessful endoscopic treatment. CONCLUSIONS: APC used in combination with piecemeal polypectomy of large colorectal adenomas is an effective and safe method of therapy, provided patient selection is careful and follow-up close.

Transabdominal ultrasound for visualizing gastric submucosal tumors diagnosed by endosonography: can surveillance be simplified?

BACKGROUND AND STUDY AIMS: Management options for gastric submucosal tumors (SMTs) include tumor removal or surveillance. If the latter is chosen, it requires repeated measurements of the tumor diameter. Although this can be achieved using endoscopy or endosonography (EUS), a less invasive and cheaper method would be welcome. The aim of this prospective study was to assess the proportion of gastric SMTs that can be visualized using transabdominal ultrasound of the water-filled stomach. PATIENTS AND METHODS: Fifty-one consecutive patients with endosonographically diagnosed gastric SMTs underwent transabdominal ultrasound examinations of the water-filled stomach performed immediately after EUS; both procedures were carried out by the same investigator. Transabdominal ultrasound was considered positive only if: firstly, the tumor was visualized unequivocally; secondly, its dimensions could be measured; and thirdly, photographic documentation could be recorded. In each case, a positive result had to be confirmed by an independent investigator, who reviewed the photographic documentation. RESULTS: The median size of SMTs on EUS was 25 mm (range 4 - 55 mm). Twelve tumors were located in the antrum, 25 in the gastric body, and 14 in the gastric fundus or cardia. Transabdominal ultrasound demonstrated the tumor in 35 of 51 patients (69 %). For tumors < or = 30 mm, the visualization rate was 61 % (22 of 36). The location of the tumor and its EUS features did not significantly affect the sensitivity of transabdominal ultrasound. CONCLUSIONS: In 69 % of patients with endosonographically diagnosed gastric SMTs, the tumor can also be visualized (and measured) using transabdominal ultrasound of the water-filled stomach. This noninvasive and inexpensive method may potentially be useful for surveillance in patients with SMTs, and further evaluation in this setting is warranted.

RACK1 protein interacts with Helicobacter pylori VacA cytotoxin: the yeast two-hybrid approach.

The VacA toxin is the major virulence factor of Helicobacter pylori. The studies on VacA intracellular expression suggest that it interacts with cytosolic proteins and that this interaction contributes significantly to vacuolization. The aim of this study was to identify the host protein(s) that interacts with the VacA protein. We used the fragments of VacA protein fused with GAL4-BD as the baits in the yeast two-hybrid approach. The yeast transformed with plasmids encoding bait proteins were screened with human gastric mucosa cDNA library, encoded C-terminal fusion proteins with GAL4-AD. Three independent His-beta-Gal-positive clones were identified in VacA-b1 screen; they matched two different lengths of cDNA encoding RACK1 protein. The specific activity of beta-galactosidase found in the yeast expressing both VacA-b1 and RACK1 fusion proteins was 12-19 times higher compared to all negative controls used. VacA is capable of binding the RACK1 in vitro as was confirmed by the pull-down assay with GST fusion VacA protein and [(35)S]Met-labeled RACK1 protein fragments.

Helical computed tomographic cholangiography versus endosonography for suspected bile duct stones: a prospective blinded study in non-jaundiced patients.

BACKGROUND: Helical computed tomography performed after intravenous administration of a cholangiographic contrast material (HCT-cholangiography) may be useful for detecting bile duct stones in non-jaundiced patients. However, this method has never been compared with other non-invasive biliary imaging tests. AIMS: To compare prospectively HCT-cholangiography and endosonography (EUS) in a group of non-jaundiced patients with suspected bile duct stones. METHODS: Fifty two subjects underwent both HCT-cholangiography and EUS. Endoscopic retrograde cholangiography (ERCP), with or without instrumental bile duct exploration, served as a reference method, and was successful in all but two patients. RESULTS: Thirty four patients (68%) were found to have choledocholithiasis at ERCP. The sensitivity for HCT-cholangiography in stone detection was 85%, specificity 88%, and accuracy 86%. For EUS the sensitivity was 91%, specificity 100%, and accuracy 94%. The differences were not significant. No serious complications occurred with either method. CONCLUSIONS: HCT-cholangiography and EUS are safe and comparably accurate methods for detecting bile duct stones in non-jaundiced patients.

Is serum bilirubin concentration the only valid prognostic marker in primary biliary cirrhosis?

From the many prognostic models for primary biliary cirrhosis (PBC) patients based on Cox's regression analysis, the Mayo model has gained the most popularity and was successfully validated in some centers. The aim of our study was to validate the Mayo survival model for Polish PBC patients and, in case of its inapplicability, to select prognostic variables and to create time-fixed and time-dependent survival models for the patients. We used database information on patients from 6 medical centers in Poland, fulfilling clinical, serological, and/or pathological criteria of PBC. The Mayo model was validated using data from 116 PBC patients. The time-fixed and time-dependent models were created using data on clinical and biochemical variables used in the Mayo model from 162 and 208 patients, respectively. The Mayo model validation was performed graphically and by one-sample log-rank tests after dividing the study sample into 3 groups of high, medium, and low risk. The survival analysis was performed using Cox's proportional hazards regression method on clinical and biochemical variables used in the Mayo model. Treatment with ursodeoxycholic acid (UDCA) was included in the time-dependent analysis. Validation showed that the Mayo model overestimated death risk in Polish PBC patients. Of the variables used in the Mayo model, serum bilirubin concentration appeared to be the only variable of prognostic importance. The analysis shows that serum bilirubin concentration holds most of the prognostic information for our PBC patients irrespective of prior treatment with UDCA.

VacA genotyping directly from gastric biopsy specimens and estimation of mixed Helicobacter pylori infections in patients with duodenal ulcer and gastritis.

BACKGROUND: The vacA genotypes and the cagA gene status were investigated in 80 Helicobacter pylori-infected patients with duodenal ulcer (DU) and 49 with gastritis only. METHODS: Lysates of gastric biopsy specimens were used directly for polymerase chain reaction-based detection. RESULTS: The ml subtype was found in 36% and 31% and the m2 in 36% and 46% of specimens from patients with DU and gastritis, respectively (P > 0.05). In 15% of samples the midregion remained unclassified. The prevalence rate of s1 subtypes was higher in cases of DU (69%) than in gastritis (43%) (P < 0.0001); the opposite correlation was observed for s2. The cagA gene was detected in 80% of patients with DU and in 52% of those with gastritis (P < 0.0001). Infections with multiple H. pylori strains exceeded 50% in both groups. CONCLUSIONS: These results suggest that vacA s1 genotype and cagA+ status are associated with higher DU prevalence and that mixed H. pylori infections are very common in our geographic region.

Topical versus Systemic 5-Aminolevulinic Acid Administration for Photodynamic Therapy of the Colon in B10.RBP Mice.

5-aminolevulinic acid (5-ALA) is an interesting photosensitizing substance for photodynamic therapy (PDT), successfully applied topically for urological malignancy. In gastroenetrology it has proven efficacy for treatment of some GI neoplasms after systemic administration. This study was aimed at investigating the possibility of topical 5-ALA administration also for the PDT of gut cancer in a mice model. 5-ALA solution at different concentrations (5%, 1.5%, and 0.5%) was instilled in the colon of mice, which was later removed and examined by fluorescence microscopy. The results of fluorescence studies were compared with those obtained in a control group treated with 5-ALA given systemically. Satisfactory epithelial fluorescence levels and good selectivity between gut layers was obtained after intracolonic 5-ALA instillation. However, mean fluorescence intensity was higher after systemic drug application. Our results suggest that 5-ALA may probably be used topically for the PDT of some gut neoplasms. © 1999 Society of Photo-Optical Instrumentation Engineers.

Randomized comparison of 1-hour topical method vs. amoxycillin plus omeprazole for eradication of Helicobacter pylori in duodenal ulcer patients.

BACKGROUND: A novel 1-h topical method eradicated Helicobacter pylori in 96% of dyspeptic patients. The eradication rate of amoxycillin/omeprazole therapy varies from 0 to 93%. AIM: To compare both methods in patients with endoscopically proven duodenal ulcer. METHODS: Eighty patients (59 males, 21 females; median age 43 years) were randomized into two therapeutic groups. The first group (group A) was treated with a 6-week course of ranitidine 300 mg/day, then omeprazole 20 mg b.d. with pronase 36000 units/day for 2 days, followed by 1-h topical therapy with a solution of bismuth, metronidazole, amoxycillin and pronase. The second group (group B) consisted of patients treated with omeprazole 20 mg b.d. and amoxycillin 2 g/day for 2 weeks, followed by a 4-week course of ranitidine 300 mg/day. Eradication of H. pylori was assessed by urease test, histology, a polymerase chain reaction and a 13C-urea breath test, all of which were performed 4 weeks after discontinuation of the antibacterial treatment. RESULTS: Eradication rates in groups A and B were 2.5% and 35% in an intention-to-treat analysis, respectively. Side-effects were encountered in 40.5% and 12.5% of subjects in groups A and B, respectively. Treatment tolerance was rated as poor by 54% of patients in group A and 2.5% of patients in group B. CONCLUSIONS: Both treatment regimens, the 1-h topical method and amoxycillin with omeprazole, have low eradication rates in patients with duodenal ulcer. In addition, the topical treatment is characterized by a high rate of side-effects and poor tolerance. Based on the results of our study, neither method can be recommended for eradication of H. pylori in patients with duodenal ulcer.

Liver graft bile duct necrosis--indication for retransplantation.

The authors describe the first in Poland case of liver retransplantation in an adult recipient, in whom the indication for the procedure was bile duct necrosis following liver transplantation due to liver cirrhosis of an uncertain origin.

Long-term results of treatment of esophageal achalasia using a Starck dilator.

Retrospective analysis was carried out among 252 patients with esophageal achalasia (135 women, 117 men, mean age 41 years) who, in the years 1961-1992, underwent 333 Starck procedures. Mean period of follow-up was 11.5 years (range 6 months to 32 years). Evaluation of the procedure was based upon the analysis of actual symptoms and radiological and endoscopic examinations in a group of 247 patients (98%). 22 patients died; all except 1 of diseases unrelated to the esophagus. The data concerning the effectiveness of therapy refer to the remaining 225 patients. The first Starck procedure gave permanent and sufficient relief of symptoms in 140 patients (62.2%). Of the remaining patients, 62 persons underwent subsequent Starck procedures, the effectiveness of which was 64.9%. The total percentage of favorable results of the procedure was 84.4%. There was no fatal complication of the Starck procedure. One perforation of the esophagus, one aspiration pneumonia and 2 cases of incarceration of the Starck apparatus were observed. There was no case of esophageal cancer in the whole group. These results confirm that the Starck procedure is a safe and effective treatment for esophageal achalasia.

Malignant transformation of benign epithelial gastric polyps.

OBJECTIVES: To compare the malignant potential of hyperplastic polyps and adenomas in relation to different histological classifications and to try to follow the natural history of the BEGP-carcinoma sequence. METHODS: During a 13-yr period (1981-1993), 811 BEGP were discovered in 432 patients in consecutive esophagogastroscopic examinations in our department. Adequate endoscopic biopsies or polypectomy specimens were histologically diagnosed as hyperplastic polyp in 751 (92.6%) and adenoma in 60 (7.4%) of the lesions, according to WHO classification. Hyperplastic lesions were further divided into two subgroups: 268 were polypoid foveolar hyperplasia (FH) and 483 were typical hyperplastic polyps (HP), according to Elster's classification. Special attention was paid to focal malignancy at the first examination or malignant transformation of BEGP during follow-up. Ninety-six patients with 220 BEGP were followed for 1-11 yr, with an average of 2 yr and 8 months. RESULTS: According to Elster's classification, there were 10/483 (2.1%) HP and 6/60 (10.0%) adenomas with focal carcinoma. Moreover, in 19/265 patients (7.1%) with HP and in 4/30 patients (13.3%) with adenomas, carcinoma was found elsewhere in the stomach. During our follow-up, 5/131 HP showed different steps of histological transformation: focal intestinal metaplasia in two, focal dysplasia in one, and focal carcinoma in two of them, which is 1.6%, 0.8%, and 1.6%, respectively. In 1/23 adenomas, focal carcinoma developed after 1 yr of observation (4.3%). Separate gastric carcinomas developed outside polyps during follow-up in 2/58 (3.5%) patients with hyperplastic polyps only. None of those with FH had focal carcinoma either at primary biopsy or during long-term observation. All proportions concerning gradual transformation of hyperplastic polyps classified as only one group according to WHO were lower. CONCLUSIONS: In contrast to hitherto existing opinions, our results give support to the idea that gastric HP, like adenomas, are susceptible to malignant transformation. It seems sensible to separate a subgroup of FH from HP, since FH have no malignant potential until they change their histology to HP. The treatment of FH and HP as one group is the main reason why the malignant potential of hyperplastic polyps is still underestimated.

[Cholecystolithiasis in the urban population of Poland]. / Kamica pecherzyka zólciowego w populacji miejskiej w Polsce.

Multicentre study was carried out in three regions of Poland aimed to assess cholecystolithiasis incidence in urban population and some potential risk factors of the disease. 10133 persons in five age groups, from 16 to 70 (6071 women and 4062 men) were examined. The examination consisted of questionnaire considered sex, age, weight, dietary habits, complaints, chronic drugs use, family history and in women number of pregnancies and deliveries as well as hormone therapy. The results obtained were analysed statistically with Chi 2 test. Cholecystolithiasis was found in 1411 persons (10.7%), among them 18% women (1083 women) and 8.2% men (328 men). Incidence rate was 180.5/1000 women and 82.0/1000 men. The obtained increase in percentage of cholecystolithiasis cases with age was statistically significant. No relation were found between the number of stones and sex of the examined persons. In 1480 persons (43.5%0 the disease was asymptotic. The studies did not prove the correlation between cholecystolithiasis in women and sex of the first child or oral contraception. Positive correlation was found between cholecystolithiasis in women, obesity, number of pregnancies and family history. In men age was most significant risk factor. Incidence of cholecystolithiasis in Poland, Western Europe and USA is similar.