Endoscopic holder-assisted percutaneous endoscopic gastrostomy placement: results of a prospective, randomized comparison study

BACKGROUND: We developed a new method of endoscope holder-assisted percutaneous endoscopic gastrostomy (PEG) placement requiring only a single physician. OBJECTIVE: This study compared the feasibility and safety of the new method with the conventional pull method of PEG performed by 2 physicians. DESIGN: Prospective, randomized comparison study. SETTING: Rural municipal hospital. PATIENTS: Eighty consecutive patients with dysphagia. INTERVENTIONS: Patients were randomized to receive PEG placement by a single physician using the endoscope holder (40 patients) or by 2 physicians using the conventional pull method (40 patients). MAIN OUTCOME MEASUREMENTS: The success rate, duration, and complications of both methods were scored. RESULTS: The success rate of PEG by either method was similar (98%) using the endoscope holder compared with 100% with the conventional method. The duration of both endoscopic procedures was also similar (12.9 +/- 2 and 11.5 +/- 2 minutes) (P = .43). No major complication occurred with either procedure. There was 1 death within 30 days (of aspiration pneumonia) 3 days after conventional PEG placement. LIMITATIONS: The number of patients evaluated is small. CONCLUSIONS: Endoscope holder-assisted PEG placement allows a single physician to perform all the important aspects of pull PEG placement under direct vision without assistance from another specially trained individual. The method appears to be as feasible and safe as the conventional pull method.     

Endoscopic injection to arrest peptic ulcer hemorrhage: a prospective, randomized controlled trial; preliminary results

Over a period of 10 months, we conducted a prospective randomized controlled trial of endoscopic injection for the arrest of peptic ulcer hemorrhage in 84 patients. We injected pure alcohol (PA, 99.8%), 50% glucose in water (G/W), 3% NaCl solution, and normal saline solution (N/S, controls) to stop bleeding. The ultimate success rates in the four groups were: 81% (17/21) in the PA group, 80% (16/20) in the 50% G/W group, 65.2% (15/23) in the 3% NaCl group, and 80% (16/20) in the N/S group (p greater than 0.05). The volume of blood transfusion (mean +/- s. e. m.) for each patient was 1,200 ml +/- 433 ml in the PA group, 1,130 +/- 356 ml in the 50% G/W group, 1,704 +/- 330 ml in the 3% NaCl group, 1,400 +/- 548 ml in the N/S group (p greater than 0.05). The duration of hospitalization (mean +/- s. e. m.) was 5.7 +/- 1.5 days in the PA group, 3 +/- 1.3 days in the 50% G/W group, 6.1 +/- 1.1 days in the 3% NaCl group, and 5 +/- 1.1 days in the N/S group (p greater than 0.05). No complication of perforation or aspiration pneumonia was observed during hospitalization. We suggest that endoscopic injection with the above solutions be used as the first line of therapeutic endoscopy for arrest of peptic ulcer hemorrhage.     

Endoscopic stenting and elective surgery versus emergency surgery for left-sided malignant colonic obstruction: a prospective randomized trial

Purpose  

This study aims to evaluate the role of colonic stenting as a bridge to surgery in acutely obstructed left-sided colon cancer.     

Ursodeoxycholic acid for primary biliary cirrhosis: final results of a 12-year,prospective, randomized,controlled trial

OBJECTIVES: The aim of this study was to evaluate whether ursodeoxycholic acid (UDCA) has any effect on the development of liver decompensation and on survival of patients with primary biliary cirrhosis (PBC). METHODS: A total of 86 patients with compensated PBC were randomly assigned to receive UDCA (n = 43) or to remain untreated (controls, n = 43). There was no significant difference in the baseline characteristics between the two groups. Mean follow-up was 7.3 +/- 3.0 yr in the UDCA and 8.1 +/- 3.1 yr in the control group. Fourteen control patients were crossed-over to UDCA therapy after a median of 3.5 yr (range 2-8 yr), at their own request. RESULTS: Liver decompensation developed in 41 patients (22 in the UDCA and 19 in the control group) and liver death or transplantation in 33 (19 in the UDCA and 14 in the control group) patients. There was no significant difference in the probability of development of liver decompensation, liver death, or transplantation (by log-rank test) between UDCA-treated and control patients, whether by an intention-to-treat or by treatment-as-received analysis. CONCLUSIONS: UDCA was not found to have any demonstrable effect on the long-term outcome of PBC and did not improve the survival of PBC patients.     

Minimally invasive versus conventional aortic valve replacement: a prospective randomized trial

BACKGROUND AND AIM OF THE STUDY: A prospective randomized study was performed to compare conventional with minimally invasive aortic valve replacement (AVR). METHODS: Forty consecutive patients scheduled for elective aortic valve surgery were prospectively randomized either to the conventional group (group A, complete median sternotomy) or minimally invasive group (group B, partial upper sternotomy). Intraoperative and postoperative clinical data, and markers of myocardial and cerebral protection were determined. Neuropsychological tests were carried out to quantify psychological disorders. RESULTS: Operative time and cardiopulmonary bypass time were slightly longer in group B, but not significantly so. No significant inter-group differences were found for postoperative pain scores and respiratory function. Chest tube drainage was significantly less in group B (495 +/- 165 versus 240 +/- 69 ml, p = 0.008). Creatine kinase (CK), CK-MB and troponin T levels were similar in both groups. Neither S-100B protein nor neuron-specific enolase levels differed significantly between groups at all sampling times. There were no strokes in the entire cohort. None of the neuropsychological tests yielded significant inter-group differences between conventional and minimally invasive surgery. CONCLUSION: The safety and reliability of AVR via a partial upper sternotomy is reported. Minimally invasive AVR can be performed with only slightly longer operative times, good cosmetic results and significantly less blood loss. A limited surgical access affected neither the patients' neurological outcome nor the efficacy of myocardial protection.     

Endoscopic saphenous vein harvesting for CABG -- a randomized,prospective trial

BACKGROUND: The saphenous vein is an established conduit for coronary revascularization. Disadvantages of traditional harvest technique are significant pain and morbidity. We compared the endoscopic harvest technique with the traditional method. METHOD: 140 coronary artery bypass graft (CABG) patients were randomized into 2 groups: endoscopic vein harvesting (EVH; n = 80) and traditional open vein harvesting (OVH; n = 60). Analysis included preoperative risk factors for wound complication, harvesting time, graft injury, and intraoperative and postoperative complications. Patient follow-up lasted 3 months. RESULTS: The preoperative risk profiles of the groups were comparable. In the EVH group, 5 patients (7.1 %) had to be switched to the open technique. EVH time was 45 +/- 6.2 min vs. 31.1 +/- 6.5 min. Two patients (2.5 %) had to be revised because of bleeding complication vs. 6 (10 %) in the OVH group. No local infections or wound complications were observed in the EVH group vs. 11 (18 %) cases in the OVH group. Two OVH cases (3.6 %) were readmitted for wound debridement. All EVH patients reported less pain and were completely satisfied by the cosmetic results. CONCLUSION: EVH is a safe and efficient technique for CABG. Morbidity was significantly lower, with reduced pain and better cosmetic results. EVH time was significantly longer compared to the traditional harvesting technique.     

Sucralfate versus ranitidine in non-ulcer dyspepsia: results of a prospective, randomized, open, controlled trial.

In an open trial, 100 patients with non-ulcer dyspepsia were randomized to receive either ranitidine 150 mg twice daily (n = 47) or sucralfate 1 g four times a day (n = 53) for four weeks. An 'intention to treat' analysis revealed that global relief in symptoms was significantly more frequent in the sucralfate group than in the ranitidine group after two weeks (77.4% vs 59.6%; p less than 0.05) and four weeks (86.8% vs 63.8%; p less than 0.001) of treatment. It is concluded that sucralfate is superior to ranitidine in providing symptomatic relief in patients with non-ulcer dyspepsia.     

EUS staging of upper GI malignancies: results of a prospective randomized trial

BACKGROUND: Electronic 270 degrees transverse-array EUS (TA-EUS) provides high-quality cross-sectional images but cannot guide FNA. Linear EUS (L-EUS) provides longitudinal images of malignancies and the ability to guide FNA. OBJECTIVE: We conducted a prospective randomized comparison of TA-EUS and L-EUS for the staging of upper-GI (UGI) malignancies. DESIGN: Forty-three patients underwent L-EUS immediately followed by TA-EUS (N = 27, 63%) or TA-EUS immediately followed by L-EUS (N = 16, 37%). PATIENTS: Forty-three subjects (mean age, 64 years; 37 men) with an UGI malignancy (4 stomach and 38 esophageal) were evaluated with both TA-EUS and L-EUS. INTERVENTIONS: Abnormal lymph nodes were sampled by FNA for cytology. RESULTS: There was agreement on the T stage by linear and radial techniques in 38 of 43 subjects (88%). Twenty-seven of 43 patients (63%) had abnormal lymph nodes by linear or transverse-array imaging. L-EUS demonstrated 66 abnormal lymph nodes in 27 subjects (average of 2.4 nodes/subject). TA-EUS demonstrated 90 abnormal lymph nodes in 27 subjects (average of 3.3 nodes/subject, P = .009, compared with L-EUS). In 16 of the 27 subjects, an FNA was performed, which was positive in 13 cases (81%) and negative in 3 cases (10%) for malignancy. CONCLUSIONS: TA-EUS and L-EUS provide similar results of T staging of UGI malignancies. However, the number of abnormal lymph nodes detected by TA-EUS was more than by L-EUS. These findings suggest that radial or transverse-array EUS imaging should be the primary method for staging of UGI malignancies.     

Endoscopic injection sclerotherapy with ligation versus endoscopic injection sclerotherapy alone in the management of esophageal varices: a prospective randomized trial

BACKGROUND/AIMS: Endoscopic injection sclerotherapy with ligation is a technique by which endoscopic injection sclerotherapy is first carried out for a target esophageal varix using an endoscope equipped with a device for endoscopic variceal ligation, and subsequently, endoscopic variceal ligation is performed for the varix together with the injection site of the sclerosing agent. The aim of this prospective, randomized trial was to compare endoscopic injection sclerotherapy with ligation with endoscopic injection sclerotherapy techniques in utility for patients with esophageal varices. METHODOLOGY: Twenty-four patients with esophageal varices who were to undergo either an elective treatment of bleeding esophageal varices or a prophylactic treatment of non-bleeding esophageal varices underwent endoscopic injection sclerotherapy with ligation (n = 12) or without ligation (n = 12). The patients were followed for a mean of 19.9 +/- 8.1 months in the endoscopic injection sclerotherapy with ligation (EISL) group and 19.5 +/- 5.4 months in the Endoscopic injection sclerotherapy (EIS) group. RESULTS: The red color sign disappeared in 10 patients in the EISL group and 3 in the EIS group (P = 0.004) after initial treatment. The length of time required for initial treatment was 16.3 +/- 4.7 min for the EISL group and 27.2 +/- 6.2 min for the EIS group (P = 0.0003). For treatment-related complications, no significant difference was noted between the 2 groups and no serious complication were noted in the 2 groups. The total quantity of ethanolamine oleate used to attain the endpoint was 17.3 +/- 7.9 mL for the EISL group and 25.2 +/- 9.7 mL for the EIS group (P < 0.05). The cumulative non-relapse rate for 2 years following attainment of the endpoint [F1, RC(-)] was 81.5% for the EISL group and 47.5% for the EIS group, producing no significant difference between the 2 groups. The cumulative non-bleeding and survival rates were 100% in the 2 groups. CONCLUSIONS: Endoscopic injection sclerotherapy with ligation is more useful for esophageal varices than endoscopic injection sclerotherapy alone.     

Skin-level gastrostomy -- long-term results from a prospective trial in gastric and jejunal application

OBJECTIVE: The usefulness of skin-level gastrostomy tubes (button systems) for maintaining nutrition support after primary insertion of percutaneous endoscopic gastrostomy (PEG) is widely accepted. After first promising experiences with newly developed skin-level gastrostomy system (Freka-Button Gastrostomy) the safety and long-term stability of this new tube was not defined. MATERIAL AND METHODS: In a cohort study we prospectively evaluated from 2.1998 until 12.2001 for ease of use, complications, time to failure and long-term follow-up of 61 Freka button gastrostomies inserted in 50 patients (mean age 57.6 years, range 6 - 78 years, 44 men, 6 women). Mean time after primary PEG placement was 6.3 months (range 1 - 30 months). RESULTS: Correct application of all buttons (48 gastric, 2 jejunal) was easy and fast (median time 11 minutes) to perform. In 56 % we used a new Seldinger guide wire technique to improve stomal passage. Within the first ten days and during long-term follow-up (median 248, range 2 - 593 days) no major complication was seen. 11 systems had to be replaced mainly due to balloon failure (median 352, range 186 - 593 days). The total observation time were 15,128 days with a system failure rate of 0.26 per year. CONCLUSION: The Freka-button systems provides an easy-to-use, safe, and feasible alternative for long-term use of skin-level gastrostomy. First jejunal application of this new device was promising but needs further evaluation.     

Filtration versus gravity leukapheresis in febrile granulocytopenic patients: a randomized prospective trial

Forty-eight patients with fever greater than 38.3 degrees C for at least 24 hr despite broad spectrum antibiotics and an absolute granulocyte count less than 1000/microliter were randomly allocated to 4 days of granulocyte transfusions obtained by leukapheresis using filtration (n = 27) or gravity (n = 21) techniques, the latter permitting simultaneous nonmechanical collection of granulocytes and platelets utilizing hydroxyethyl starch as a sedimenting agent. Patient characteristics and dose of granulocytes obtained from both techniques were similar. Complete response to granulocyte transfusions was established by a reduction in temperature to less than 37.2 degrees C sustained for at least 48 hr after the fourth transfusion with sterilization of cultures where previously positive and diminution of measurable infection when present. This occurred in 6/21 (29%) for gravity leukapheresis and 9/27 (33%) for filtration leukapheresis. An additional group had diminution in temperature and clinical improvement during transfusions (6/21 gravity leukapheresis versus 10/27 filtration leukapheresis). Eighty-six percent of patients transfused with gravity leukapheresis cells were alive at day 20 compared with 81% for filtration leukapheresis cells. Transfusion reactions were comparable. Thus, gravity leukapheresis appears to be as efficacious as filtration leukapheresis for treating granulocytopenic febrile patients, with the added advantages of availability to any blood bank without new equipment, of having platelets as by-products, and of not requiring donor heparinization.     

Trimethoprim-sulfamethoxazole versus pentamidine for Pneumocystis carinii pneumonia in AIDS patients: results of a large prospective randomized treatment trial.

OBJECTIVE: To compare the clinical efficacy and safety of trimethoprim-sulfamethoxazole (TMP-SMX) with pentamidine in the therapy of Pneumocystis carinii pneumonia (PCP) in patients with AIDS. PATIENTS, PARTICIPANTS: TMP-SMX (TMP, 20 mg/kg/day plus SMX, 100 mg/kg/day) was compared with pentamidine (4 mg/kg/day), both administered intravenously for 21 days in a prospective randomized treatment trial of 163 patients diagnosed with PCP between November 1984 and May 1988. RESULTS: Ninety-two evaluable patients received TMP-SMX as initial therapy; 68 received pentamidine. Failure to complete therapy was common. Of those receiving TMP-SMX, 39 (42%) required change in therapy because of failure to respond, and an additional 31 (34%) because of drug toxicity. This compared with 27 (40%; P = 0.733) and 17 (25%; P = 0.235), respectively, in the pentamidine-treated group. The overall survival rates were similar in the two groups, 62 out of 92 (67%) initially administered TMP-SMX versus 50 out of 68 (74%) initially administered pentamidine (P = 0.402). The survival rates for patients requiring a change in therapy because of failure to respond was 46% (18 out of 39) for the TMP-SMX group compared with 56% (15 out of 27) for the pentamidine group. When a change in therapy was made because of toxicity, survival rates were 97% (30 out of 31) for those receiving TMP-SMX versus 94% (16 out of 17) for those receiving pentamidine. CONCLUSION: TMP-SMX and pentamidine are of equivalent efficacy as initial therapies for PCP in patients with AIDS.     

Antibiotic prophylaxis in percutaneous endoscopic gastrostomy (PEG)--results from a prospective randomized multicenter trial

OBJECTIVE: To determine the efficacy of antibiotic prophylaxis in percutaneous endoscopic gastrostomy (PEG) as a part of a standardized regimen. METHODS: An open prospective randomised multicenter study in 216 patients. 106 received ceftriaxone 1 g i.v. 30 min preinterventionally and 110 no study medication. A standardized protocol was followed for PEG preparation, insertion, and aftercare; all patients received a 15 French gastrostomy tube. Follow-up of local and systemic infection and clinical course was continued to postintervention day 10. An aggregate erythema and exudation score > 3 or the presence of pus was taken as indicative of peristomal infection. The pharmacoeconomics of antibiotic use were also examined. RESULTS: In no-prophylaxis patients, wound infection rates were 23.6% on day 4 and 24.5% on day 10 vs. 7.6% (p < 0.05) and 11.4% (p < 0.05), respectively, in prophylaxis patients. Results were disproportionally better in tumor patients in comparison with neurological patients. Patients systemic infection rates were 11.8% vs. 1.9% in noprophylaxis vs. prophylaxis (p < 0.05), and overall infection rates 36.3% vs. 13.3%, respectively (p < 0.05). Pneumonia was more frequent in patients with underlying neurological disease and reduced in the prophylaxis group. Antibiotic and application costs were similar in both groups (p = 0.400). CONCLUSIONS: Single-dose ceftriaxone 1 g is a effective prophylaxis against local and systemic infection after PEG and should be a part of a standard regimen.     

Lack of effect of colchicine in alcoholic cirrhosis: final results of a double blind randomized trial

BACKGROUND: Colchicine, an inhibitor of collagen synthesis, has been suggested as potentially beneficial in cirrhosis. OBJECTIVE: This long-term, randomized, double blind, placebo controlled trial was conducted in order to evaluate the efficacy of colchicine in alcoholic cirrhosis. METHODS: Ambulatory patients with biopsy proven alcoholic cirrhosis, presenting from 1989 to 1997, with no exclusion criteria (e.g. Child-Pugh C, bilirubin > 10 mg/dl and gastrointestinal bleeding in the previous 15 days), were randomized to receive orally, 5 days/week, 1 mg/day of colchicine or placebo. MAIN OUTCOME MEASURES: Results were analysed on an intention to treat basis, for survival, incidence of complications, biochemical liver tests and safety. RESULTS: Twenty-nine patients received colchicine and 26 placebo; characteristics of both groups were similar. The median follow-up was 40.6 (1.4-126.3) months in the colchicine versus 42.4 (5.7-118.2) months in the placebo group (NS). No significant side effects were reported. During follow-up, there were no significant differences in compliance and alcohol abstinence (86% vs 85%). Overall survival was not statistically different (P = 0.38). Cumulative 3-year survival rates were 74.9% in the colchicine versus 91.4% in placebo group (NS). The annual incidence rate of complications was similar with colchicine or placebo: gastrointestinal bleeding, 1.5% vs 1.2%; ascites, 3.7% vs 3.7%; and encephalopathy, 1.0% vs 0.9%. The comparison of changes in biochemical parameters between groups did not show any significant difference. CONCLUSIONS: Although well tolerated, colchicine does not appear to overcome the progression and natural history of long-established alcoholic cirrhosis.