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Biomedical subjects

Guido Costamagna

Publications and source records attributed to Guido Costamagna.

At least 19 recordsLinked to original sources

5-fluorouracil-based chemoradiation in unresectable pancreatic carcinoma: Phase I-II dose-escalation study.

PURPOSE: A Phase I-II dose-escalation study was performed to evaluate the possible impact of the dose on response, toxicity, pain relief, and outcome in patients with unresectable pancreatic carcinoma. METHODS AND MATERIALS: A total of 50 patients entered the study. The external beam radiotherapy (RT) dose was 39.6 Gy in the first 15 patients, 50.4 Gy in the next 15 patients, and 59.4 Gy in the remaining 20 patients, at five 1.8-Gy fractions weekly. During external beam RT, patients received concurrent continuous infusion of 5-fluorouracil (1000 mg/m(2) on Days 1-4 and 21-24). Patients were evaluated for toxic reactions, local disease control, survival, and pain relief. RESULTS: No treatment-related deaths occurred from acute toxicity. Four patients required a temporary treatment interruption because of acute hematologic (2 patients) or GI (2 patients) toxicity, not correlated with the delivered RT dose. Three patients (6%) developed late toxicity (duodenal ulcer in 2 and duodenal stenosis in 1). All patients who developed late toxicity had received a dose of 59.4 Gy. At univariate analysis, only the RT dose correlated significantly with the incidence of late toxicity (at 2 years, 39.6-50.4 Gy resulted in 0% and 59.4 Gy resulted in 58.2%; p = 0.023). At multivariate analysis, the RT dose also showed a trend with the incidence of late side effects (p = 0.052). Overall, 6 patients had a partial response (12%) and 44 (88%) had no change. The overall response rate was 8.0% (95% confidence interval, 1.5-20.5%). The rate of response was not different in the three groups. In-field locoregional disease progression was seen in 7 patients (14.0%). Distant relapse was documented in 34 patients (68.0%). None of analyzed variables, in particular, the RT dose delivered, showed a statistically significant correlation with objective response, local control, incidence of metastasis, disease-free survival, or overall incidence of pain symptoms after therapy. The whole group median survival was 9 months. The actuarial survival rate at 1, 2, and 3 years was 31.3%, 2.8%, and 0.0%, respectively. None of analyzed parameters correlated significantly with survival at univariate or multivariate analysis. CONCLUSION: In a Phase I-II study, the association of high RT doses with the incidence of severe toxicity in the treatment of unresectable pancreatic carcinoma was confirmed. Furthermore, this dose-escalation study did not document a clearcut correlation, using 5-fluorouracil-based chemoradiation, between the radiation dose and clinical outcome.

Analysis of Variance↗

Palliation of patients with malignant gastric outlet obstruction with the enteral Wallstent: outcomes from a multicenter study.

BACKGROUND: Endoscopic placement of self-expandable metallic stents for palliation of patients with malignant gastric outlet obstruction is safe and feasible. METHODS: Patients with malignant gastric outlet obstruction undergoing enteral stent insertion were identified from endoscopy databases. Duration of oral intake after stent insertion was calculated by using the log-rank test. Factors associated with duration of oral intake were assessed by using Cox multivariable regression analysis. RESULTS: A total of 176 patients (mean age 65 [14] years) treated at 4 centers from 1996 to 2003 were identified. Obstruction was caused by cancer of the pancreas in 84, the stomach in 20, the bile duct in 15, the major duodenal papilla in 8, another primary site in 16, and metastases in 33. The site of obstruction was the duodenum in 125, the distal stomach in 17, the stomach and the duodenum in 18, and surgical anastomosis in 16 patients. Stent deployment was technically successful in 173. Complications occurred in 14 patients. Seventeen patients were lost to follow-up. Of the remaining 159 patients, 133 resumed oral intake for a median time of 146 days: 95% CI [65, 202]. On regression analysis, chemotherapy after stent placement was associated with prolonged duration of oral intake (hazard ratio 0.41: 95% CI [0.23, 0.72]). CONCLUSIONS: After enteral stent insertion for malignant gastric outlet obstruction, 84% of patients resumed oral intake for a median time of 146 days. Chemotherapy after enteral stent insertion was independently associated with prolongation of oral intake.

Aged↗

Endoscopic stenting for biliary and pancreatic malignancies.

Endoscopic treatment of pancreatobiliary malignancies has been recognized in the last decades as the treatment of choice in inoperable patients. Endoscopic armamentarium includes biliary stents (plastic and metallic) to bypass neoplastic strictures of the biliary tree, and pancreatic stents to palliate the obstructive pain caused by stenoses of the main pancreatic duct. A major issue is the long-term patency of plastic stents that will eventually clog on average after 3 to 4 months. Self-expandable metallic stents have longer patency, but they can also become occluded by tumor ingrowth or overgrowth; they are also much more expensive; their use is thus recommended in patients with longer life expectancy. Decompression of the dilated main pancreatic duct in pancreatic carcinoma may be effective in the relief of obstructive pain. Endoscopic palliation in pancreatic and biliary malignancies appears safe and effective; management of patient in referral centers, with an available team of gastroenterologists with endoscopic skills, surgeons, and radiologists is recommended.

Bile Duct Neoplasms↗

Hilar tumours.

Tumours that involve the confluence of the bile ducts in the liver hilum provide a major therapeutic challenge. Adequate palliation requires relief of jaundice. Even though jaundice can be relieved if only 30% of the liver is drained, the presence of undrained bile ducts may result in pruritus and a continued risk of cholangitis and hepatic abscess. The biliary anatomy is defined by cholangiography, which today can be performed by magnetic resonance; the stricture is dilated, and plastic or metallic stents are endoscopically inserted over a guidewire. Patients with complex hilar strictures may benefit from the insertion of one or more stents, although there is debate about how many are necessary. The present article provides specific technical details, describes comparative trials of unilateral versus bilateral biliary drainage and explores new techniques that warrant further investigation.

Bile Duct Neoplasms↗

Current management of postoperative complications and benign biliary strictures.

Postoperative complications after surgery of the biliary tract are usually amenable to endoscopic treatment. Such complications are most frequent after laparoscopic cholecystectomy. Bile leaks and bile duct strictures are the two main biliary injuries. Bile leaks are usually detected during the early postoperative period and can be treated by endoscopic drainage of the biliary tree (endoscopic sphincterotomy with or without nasobiliary drain). Postoperative biliary strictures are usually identified months or years after surgery. Endoscopic placement of an increasing number of plastic stents can achieve morphologic disappearance of the stricture and persistent dilation on long-term follow-up in most cases.

Bile↗

Comparison of two dosing regimens of gabexate in the prophylaxis of post-ERCP pancreatitis.

OBJECTIVES: A continuous 13-h infusion of gabexate starting 30-90 min before endoscopic cholangiopancreatography (ERCP) can reduce postprocedural pancreatitis, the onset of which is generally observed within the first 6 h after ERCP. This study was designed to verify whether a 6.5-h infusion of gabexate was as effective as a 13-h infusion, at the same concentration, for reducing the incidence of post-ERCP pancreatitis (primary endpoint) and pancreatic hyperenzymemia and pain (secondary endpoints). METHODS: A total of 434 patients (201 male and 233 female; mean age 63.9 yr, range 18-96 yr) scheduled for ERCP were prospectively recruited in 25 Italian centers. Patients were randomized double-blind to two treatment groups. All subjects enrolled were first treated with a 500-mg continuous intravenous infusion of gabexate, starting 30 min before the endoscopic maneuvers and continuing up to 6.5 h after it. Over the next 6.5 h, 214 patients (group I) continued the infusion of gabexate (for a total of 1 g over 13 h) and 220 patients (group II) were given placebo (saline solution). RESULTS: The overall incidence of acute pancreatitis was 1.8% (eight patients), which included 1.4% in group I (three of 214 patients) and 2.2% in group II (five of 220 patients). Serum amylase and lipase values over time, peak levels of the two enzymes, pancreatic pain, and need for analgesics did not significantly differ in the two groups. CONCLUSIONS: These results suggest that a 6.5-h infusion of gabexate (for a total of 500 mg) is not less effective than a 13 h infusion, with evident savings.

Acute Disease↗

Transnasal extraction of residual biliary stones by Seldinger technique and nasobiliary drain.

BACKGROUND: Complete endoscopic clearance of bile duct stones is unsuccessful in up to 30% of patients at the first attempt, necessitating further endoscopic procedures. A novel transnasal approach for extraction of these residual stones using Seldinger technique and a nasobiliary drain was evaluated. METHODS: Twenty-one patients with residual biliary stones after ERCP underwent transnasal extraction under fluoroscopy without sedation. A 0.035-inch guidewire was inserted though the previously placed nasobiliary drain into the intrahepatic ducts. The nasobiliary drain was removed, leaving the guidewire in place. A double-lumen extraction balloon was inserted over the guidewire. Multiple withdrawal maneuvers of the inflated balloon were performed to clear the bile duct. RESULTS: Residual stones were present in the extrahepatic and intrahepatic ducts in, respectively, 18 and 3 patients. The mean largest stone diameter was 5.9 mm (range, 3-12 mm). Seventeen patients had a single stone. Complete duct clearance was achieved in 17 patients (81%). The procedure was unsuccessful because of guidewire dislodgement in 3 patients and inability to pass the guidewire through the nasobiliary drain in 1 patient. There was no procedure-related complication. CONCLUSIONS: Transnasal extraction of residual biliary stones after ERCP with the Seldinger technique is safe and feasible with reasonable success and can avoid the inconvenience and cost of a repeat ERCP.

Bile Duct Diseases↗

A prospective trial comparing small bowel radiographs and video capsule endoscopy for suspected small bowel disease.

BACKGROUND & AIMS: This study was undertaken to prospectively compare the clinical outcomes of small bowel radiographs with the wireless capsule endoscopy. METHODS: Twenty-two patients were selected consecutively because of suspected small bowel disease. Two patients were excluded owing to ileal stenosis. Thus, the results of barium follow-through and the Given M2A wireless video capsule (Given Imaging Ltd., Yoqneam, Israel) endoscopy were compared in 20 patients (13 men; mean age, 52.5 yr; range, 29-78 yr). RESULTS: Barium follow-through was normal in 17 patients and showed ileal nodularity in 3 patients. Capsule endoscopy was normal in 3 patients and showed positive findings in the remaining 17 patients. The barium study was considered diagnostic in 4 (20%) patients. The capsule endoscopy was considered diagnostic in 9 (45%) patients, suspicious in 8 (40%) patients, and failed in 3 (15%) patients. For obscure gastrointestinal (GI) bleeding, the diagnostic potential of barium follow-through was much worse as compared with the capsule endoscopy (5% vs. 31%, P < 0.05). Capsule endoscopy was well tolerated and better accepted by patients when compared with the most recently performed endoscopic procedure. CONCLUSIONS: The video capsule endoscope was found to be superior to small bowel radiograph for evaluation of small bowel diseases. However, this novel wireless endoscope system needs further assessment because of limitations such as difficulties in interpretation of potentially nonspecific findings.

Adenomatous Polyposis Coli↗

Use of a duodenoscope to manage complications at the ureteroileal anastomotic site after total urinary bladder resection and the Bricker procedure.

BACKGROUND: A novel flexible endoscopic technique is described for the treatment of ureteroileal strictures and leaks after the Bricker procedure. METHODS: Seventeen patients with 24 ureteroileal complications (strictures, 22; leaks, 2) were treated under conscious sedation with a side-viewing duodenoscope. The ureter was cannulated and stent insertion, dilation, or both were performed. RESULTS: Immediate technical success was achieved in 19 of the 24 (79.2%) ureteroileal complications. Treatment included stent placement alone in 12, dilation plus stent in 4, intraileal ureter resection plus stent with or without dilation in 3, and removal of ureteral calculi in 1. The procedure was unsuccessful in 5 (20.8%; failure to visualize ureteroileal anastomosis 4, unsuccessful cannulation 1). No major complications occurred. The 14 patients treated successfully were followed (mean 43 months, range 2-132 months) and a satisfactory outcome was observed in all. Partial stent displacement occurred in 2 patients and ureteral calculi developed in 2 patients. Three patients died with a stent in situ; no death was stent-related. Eleven patients are alive and asymptomatic, 5 with a stent in situ. In 6 patients, the stent was extracted after a mean of 36 months and all remained asymptomatic during a mean further follow-up of 41 months. CONCLUSION: Treatment of ureteroileal anastomotic complications with a flexible duodenoscope and endoscopic techniques is safe, simple, and noninvasive with good success and excellent long-term results. This approach can be recommended as first-line therapy in patients with ureteroileal anastomotic complications.

Adult↗

Endoscopic implantation of a biopolymer in the lower esophageal sphincter for gastroesophageal reflux: a pilot study.

BACKGROUND: GERD is the most frequent disorder of the esophagus. Endoscopic minimally invasive treatment is desirable. However, the results of injection techniques have been disappointing. METHODS: A pilot study was conducted in patients with GERD, who required continuous therapy with a proton pump inhibitor, in which ethylene-vinyl-alcohol was injected into the muscle of the gastric cardia. Primary endpoints were the safety of the procedure, the effect on lower esophageal sphincter pressure and the stability of the injected material. A secondary endpoint was the effect on heartburn score after discontinuation of treatment with a proton pump inhibitor. RESULTS: Ethylene-vinyl-alcohol injection into the cardia resulted in circular diffusion of the product in 10 of 15 cases, suggesting that implantation into the muscle is feasible. Lower esophageal sphincter pressure was increased in 13 of 15 cases at 1 month and was sustained at a median follow-up of 6 months (range 4-12 months). Mean plus minus SEM of lower esophageal sphincter pressures (15 patients) were 12.2 plus minus 0.9, 18.7 plus minus 1.5 (p = 0.001 at baseline), and 16.7 plus minus 1.3 mm Hg (p = 0.038 from baseline) at, respectively, baseline, 1 month follow-up, and final follow-up. There was also a sustained reduction in heartburn score (off proton pump inhibitor) (3.40 plus minus 0.13 vs. 1.53 plus minus 0.24 and 1.87 plus minus 0.26 at baseline vs. 1 month and final follow-up, respectively; p < 0.01). Nine of the 15 patients had more than 50% of the injected material in place at second follow-up (at 6 months for 8 patients; at 12 months for 1 patient). In only 2 patients was there loss of more than 75% of injected ethylene-vinyl-alcohol. Persistence of greater than 50% of the material was associated with achievement of a circular injection. Only 4 patients had to resume therapy with a proton pump inhibitor. Mild retrosternal discomfort was observed in 8 patients; this disappeared in all cases after a maximum of 3 days. CONCLUSIONS: Ethylene-vinyl-alcohol implantation in the muscle of the cardia is feasible and safe. It leads to a sustained increase in resting lower esophageal sphincter pressure. This is associated with a sustained improvement in heartburn score for patients who previously required continuous therapy with a proton pump inhibitor.

Absorbable Implants↗

Endotherapy of early onset idiopathic chronic pancreatitis: results with long-term follow-up.

BACKGROUND: Idiopathic chronic pancreatitis that presents at age 35 years or younger has been classified as early onset type and is often characterized by chronic severe pain. Endotherapy, with drainage of the main pancreatic duct, can lead to control of pain if ductal hypertension is an important cause. Long-term results of endotherapy in patients with early onset idiopathic chronic pancreatitis are reported herein. METHODS: This retrospective study consists of 11 patients (6 men, 5 women; mean age 24.2 years, range 16-34 years) treated endoscopically in a 6.5-year period. The indication for treatment was pain in all patients and all had a dilated main pancreatic duct on pancreatography. The objectives of endoscopic treatment were to obtain good drainage of the pancreatic duct and complete clearance of ductal stones. RESULTS: Treatment was successful in all patients with no procedure-related mortality and with mild complications. Seven patients remained free of pain relapses after a mean follow-up of 78.3 months (37-116 months). Seven relapses of pain were recorded in the remaining 4 patients. Endoscopic retreatment was successful in all cases. The difference between the number of hospitalizations during the year before treatment (mean 2.2, range 1-9) and the year after (mean 0.3, range 0-2) was statistically significant (p < 0.01). Statistical significance was maintained at 3 and 6 years' follow-up. CONCLUSIONS: Endoscopic treatment could be regarded as the initial management of choice for patients with early onset idiopathic chronic pancreatitis.

Adolescent↗