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Biomedical subjects

Guido Costamagna

Publications and source records attributed to Guido Costamagna.

At least 19 recordsLinked to original sources
PubMed2006

Treatment for painful calcified chronic pancreatitis: extracorporeal shock wave lithotripsy versus endoscopic treatment: a randomised controlled trial.

BACKGROUND: In chronic pancreatitis, obstruction of the main pancreatic duct (MPD) may contribute to the pathogenesis of pain. Pilot studies suggest that extracorporeal shock wave lithotripsy (ESWL) alone relieves pain in calcified chronic pancreatitis. AIM: To compare ESWL alone with ESWL and endoscopic drainage of the MPD for treatment of pain in chronic pancreatitis. SUBJECTS: Patients with uncomplicated painful chronic pancreatitis and calcifications obstructing the MPD. METHODS: 55 patients were randomised to ESWL alone (n = 26) or ESWL combined with endoscopy (n = 29). RESULTS: 2 years after trial intervention, 10 (38%) and 13 (45%) patients of the ESWL alone and ESWL combined with endoscopy group, respectively, had presented pain relapse (primary outcome) (OR 0.77; 95% CI 0.23 to 2.57). In both groups, a similar decrease was seen after treatment in the MPD diameter (mean decrease 1.7 mm; 95% CI 0.9 to 2.6; p<0.001), and in the number of pain episodes/year (mean decrease, 3.7; 95% CI 2.6 to 4.9; p<0.001). Treatment costs per patient were three times higher in the ESWL combined with endoscopy group compared with the ESWL alone group (p = 0.001). The median delay between the onset of chronic pancreatitis and persistent pain relief for both groups was 1.1 year (95% CI 0.7 to 1.6), as compared with 4 years (95% CI 3 to 4) for the natural history of chronic pancreatitis in a reference cohort (p<0.001). CONCLUSIONS: ESWL is a safe and effective preferred treatment for selected patients with painful calcified chronic pancreatitis. Combining systematic endoscopy with ESWL adds to the cost of patient care, without improving the outcome of pancreatic pain.

Abdominal Pain↗
PubMed2006

Endoluminal fundoplication.

In GERD patients in whom pharmacological therapies are ineffective and anti-reflux surgery is not indicated, a viable option could be proposed. To date, several endoscopic antireflux procedures, involving sewing, injection and/or implant, and radiofrequency are available. The sewing techniques demonstrated good clinical results, with reduction in proton pump inhibitors consumption; despite significant changes in esophageal manometry and/or acid exposure time reduction and healing of esophagitis were noted only in few patients.

Endoscopy, Gastrointestinal↗
PubMed2006

Self-expanding stents in oesophageal cancer.

The main therapeutic concern in patients with inoperable oesophageal cancer is palliation of dysphagia. Self-expandable metal stents are widely used because they are safer than conventional plastic stents, offer rapid relief from dysphagia and may seal off tracheo-oesophageal fistulae. Self-expanding metal stents, particularly when uncovered, are, however, associated with the disadvantage of tumour ingrowth. Self-expandable plastic stents are entirely covered and easy to reposition in case of migration and usually induce less inflammatory proliferation at their flanges when compared with metal stents. The major disadvantage of the current version of plastic stents is the large diameter and stiffness of the stent delivery system when compared with metal stents. Therefore, plastic stents are more difficult to place in patients with angulated strictures or with tumours located in the cervical oesophagus near the upper sphincter.

Constriction, Pathologic↗
PubMed2005

Chemoradiation and brachytherapy in biliary tract carcinoma: long-term results.

PURPOSE: To evaluate long-term effects of chemoradiation and intraluminal brachytherapy in terms of local control, disease-free survival, overall survival, and symptom relief in patients with unresectable or residual extrahepatic biliary carcinoma. METHODS AND MATERIALS: Twenty-two patients with unresectable (17 patients) or residual (5 patients) nonmetastatic extrahepatic bile tumors received external beam radiation therapy (39.6-50.4 Gy) between 1991 and 1997. In 21 patients, 5-fluorouracil (96-h continuous infusion, Days 1-4, 1,000 mg/m2/day) was administered. Twelve patients received a boost of intraluminal brachytherapy with 192Ir wires (30-50 Gy) 1 cm from the source axis. RESULTS: During external beam radiotherapy, 10 patients (45.4%) developed Grade 1 to 2 gastrointestinal toxicity. In patients with unresectable tumor who could be evaluated, the clinical response was 28.6% (4 of 14). Two patients showed complete response. In all 22 patients, median durations of local control, disease-free survival, and overall survival were 44.5 months, 16.3 months, and 23.0 months, respectively. Two patients who received external beam radiation therapy and intraluminal brachytherapy developed late duodenal ulceration. In patients with unresectable tumors, median survival was 13.0 months and 22.0 months in those treated with and without brachytherapy, with 16.7% and no 5-year survival, respectively (p=0.607). Overall 5-year survival was 18.0%: 40% and 11.7% in patients treated with partial resection and in those with unresectable tumor, respectively (p=0.135). CONCLUSION: This study confirmed the role of concurrent chemoradiation in advanced biliary carcinoma; the role of intraluminal brachytherapy boost remains to be further analyzed in larger clinical trials.

Adult↗
PubMed2005

The prognostic effect of clinical staging in pancreatic adenocarcinoma.

BACKGROUND: The importance of pancreatic cancer staging is uncertain. The aim of this report was to evaluate the accuracy of combined standard imaging techniques in predicting the pathologic stage and to evaluate the prognostic effect of clinical staging to identify patient groups in which laparoscopy and laparotomy could be beneficial. METHODS: Fifty-four patients were included in this analysis. The techniques used for clinical staging were endoscopic retrograde cholangiopancreatography, abdominal computed tomographic scan, and ultrasonography. All patients underwent both clinical and surgical/pathologic staging. A comparison was performed between presurgical stage and surgical/pathologic stage. The prognostic effect of different factors on survival was evaluated with both univariate (log-rank) and multivariate (Cox) analysis. RESULTS: Sensitivity and specificity for vascular involvement were 73.9% and 96.3%, respectively. Sensitivity and specificity for nodal involvement were 63.6% and 95.4%, respectively. A total of 33.3% of patients showed a higher than expected pathologic stage, and 3.7% showed a lower than expected pathologic stage, by comparing clinical and pathologic evaluation. A highly significant correlation was observed between clinical T stage (P = .0067) and tumor diameter (P = .0037) and patient survival. Maximal prognostic differentiation was observed by dividing patients into two groups based on imaging results: group A (favorable prognosis) and group B (unfavorable prognosis). The median survival was 25.1 and 8.0 months for group A and B, respectively. Five-year survival was 20.1% and 0%, respectively (multivariate analysis: P = .0007). CONCLUSIONS: Integrated standard imaging studies achieved reasonable diagnostic accuracy in our analysis. A single classification based on clinical stage and tumor diameter evaluated by imaging predicts prognosis in patients with pancreatic carcinoma.

Adenocarcinoma↗
PubMed2005

Sacral neuromodulation in treatment of fecal incontinence following anterior resection and chemoradiation for rectal cancer.

PURPOSE: Fecal incontinence may occur in patients who have undergone anterior resection for rectal cancer without presenting sphincter lesions. Chemoradiation may contribute to disrupting continence mechanisms. Treatment is controversial. Assessment of fecal incontinence in patients who agreed to integrate treatment for rectal cancer and treatment with sacral neuromodulation are reported. METHODS: Fecal incontinence following preoperative chemoradiation and anterior resection for rectal cancer was evaluated in four patients. A good response was observed during the percutaneous sacral nerve evaluation test, and so permanent implant of sacral neuromodulation system was performed. Reevaluation was performed at least two months after implant. RESULTS: After device implantation, the mean fecal incontinence scores decreased, and the mean number of incontinence episodes dropped from 12.0 to 2.5 per week (P < 0.05). Permanent implant resulted in a significant improvement in fecal continence in three patients, and incontinence was slightly reduced in the fourth. Manometric parameters agreed with clinical results: maximum and mean resting tone and the squeeze pressure were normal in three patients and reduced in one. In these same three patients, neorectal sensation parameters increased when the preoperative value was normal or below normal and decreased when the preoperative value was higher than normal, whereas in one patient in whom extremely low values were recorded all of the parameters decreased significantly. CONCLUSIONS: Fecal incontinence following anterior resection and neoadjuvant therapy should be carefully evaluated. If a suspected neurogenic pathogenesis is confirmed, sacral neuromodulation may be proposed. If the test results are positive, permanent implant is advisable. Failure of this approach does not exclude the use of other, more aggressive treatment.

Combined Modality Therapy↗
PubMed2005

The European experience with double-balloon enteroscopy: indications, methodology, safety, and clinical impact.

BACKGROUND: Double-balloon enteroscopy (DBE) is a new technique that allows high-resolution visualization, biopsies, and therapeutic interventions in all segments of the GI tract. The objective of the study was to evaluate the indications, the safety, and the clinical impact of DBE. METHODS: This is a retrospective analysis conducted at 4 European medical centers. A total of 62 patients with suspected or documented small-bowel diseases were investigated by DBE. A total of 89 procedures were performed (26 and 9 patients from the oral or the anal route, respectively; 27 patients from both). The main outcome measurements were complications, depth and time of insertion, diagnostics, and therapeutics rates. RESULTS: No complications occurred. Mean time was 70 +/- 30 minutes and 90 +/- 35 minutes from the oral and the anal route, respectively. Length of insertion was 254 +/- 174 cm beyond the pylorus, 180 +/- 150 cm beyond the ileocecal valve, whereas the entire small bowel was completely explored in 10 patients. DBE was diagnostic in 80% of the patients: in 29 of 33 of patients with GI bleeding, in one of 5 patients with iron deficiency anemia and positive fecal occult blood testing, in 3 of 5 patients with chronic diarrhea, in two of 3 patients with abdominal pain, in two of 3 patients with GI cancer (follow-up), in all patients with suspected or refractory celiac disease, and in two of 3 patients with Crohn's disease. Treatment was performed in 41.9% of patients (22 polyps and 29 angioectesias). CONCLUSIONS: DBE is a safe and feasible diagnostic and therapeutic tool for suspected or documented small-bowel diseases. At present, the best candidates for the procedure appear to be those with obscure GI bleeding.

Endoscopes, Gastrointestinal↗
PubMed2005

Endoscopic removal of malfunctioning biliary self-expandable metallic stents.

BACKGROUND: Endoscopic removal of malfunctioning self-expandable metallic biliary stents (SEMS) is difficult and not well described. The aim of this study is to review the indications, the techniques, and the results of SEMS removal in a cohort of patients with malfunctioning stents. METHODS: All patients who underwent an attempt at endoscopic removal of biliary SEMS over a 5-year period were retrospectively identified. The main indications for SEMS removal were the following: distal migration of the stent or impaction to the duodenum, impaction into the bile-duct wall, tissue ingrowth, and inappropriate length of the stent causing occlusion of intrahepatic ducts. SEMS were removed by using foreign-body forceps or polypectomy snares. RESULTS: Endoscopic removal of 39 SEMS (13 uncovered and 26 covered) was attempted in 29 patients (17 men; mean age, 66 years). SEMS extraction was attempted after a mean of 7.5 months (8.75 months standard deviation) post-SEMS insertion. Removal was successful in 20 patients (68.9%) and in 29 SEMS (74.3%). Covered SEMS were effectively removed more frequently than uncovered ones: 24 of 26 (92.3%) and 5 of 13 (38.4%), respectively (p < 0.05). No major complications were recorded. Multivariate analysis showed that the time interval between insertion and removal, SEMS length, stent-mesh design (zigzag vs. interlaced), and indication for removal were not predictive of success at stent removal. CONCLUSIONS: Endoscopic removal of biliary SEMS is feasible and safe in more than 70% of cases. Because only 38% of uncovered SEMS were removable, the presence of a stent covering is the only factor predictive of successful stent extraction. The presence of diffuse and severe ingrowth was the main feature limiting SEMS removal.

Aged↗
PubMed2005

Efficacy of main pancreatic-duct endoscopic drainage in patients with chronic pancreatitis, continuous pain, and dilated duct.

BACKGROUND: The aim of endoscopic treatment in patients with chronic pancreatitis is to achieve decompression of the pancreatic duct, because duct obstruction with increased pressure within the duct is one of the leading causes of pain in these patients. The majority of patients suffer from relapsing pain, thus making it difficult to evaluate the efficacy of therapy. The outcome of endoscopic treatment on pain has been evaluated in patients with continuous pain (present for more than 1 month, at least 5 days per week, requiring daily analgesic therapy) and dilated duct. METHODS: Of 343 patients who underwent endotherapy for chronic pancreatitis in a 15-year period, 22 (6.4%)(19 men, mean age 48 years, alcohol abuse 14) had continuous pain and a dilated pancreatic duct. RESULTS: Endotherapy was successful in all patients, with no procedure-related mortality and only mild complications. Pain disappeared, and analgesics could be discontinued in all patients immediately after endotherapy. Six patients are pain free after a mean period of 5.5 years. One pain-free patient died after 3.4 years from myocardial infarction. Five patients were successfully endoscopically re-treated for pain relapses. Four patients underwent surgery for frequent pain relapses after a mean period of 2.5 years. Six patients were lost to follow-up. CONCLUSIONS: Endotherapy should be considered as the initial treatment of choice in patients with chronic pancreatitis, dilated duct, and continuous pain.

Adult↗
PubMed2005

Nonresorbable copolymer implantation for gastroesophageal reflux disease: a randomized sham-controlled multicenter trial.

BACKGROUND & AIMS: This aim was to determine whether endoscopic implantation of a biocompatible nonresorbable copolymer (Enteryx; Boston Scientific Corp, Natick, MA) is a more effective therapy for gastroesophageal reflux disease (GERD) than a sham procedure. METHODS: In a randomized, single-blind, prospective, multicenter clinical trial, 64 patients with GERD were enrolled whose symptoms were well controlled by proton pump inhibitor (PPI) therapy and rapidly recurred after cessation of PPI therapy. Thirty-two patients were assigned to Enteryx implantation and 32 to a sham procedure consisting of standard upper endoscopy. Patients in both groups with unsatisfactory symptom relief after 3 months were eligible for re-treatment by Enteryx implantation. The primary study end point was > or =50% reduction in PPI use. Secondary end points included > or =50% improvement in GERD score and the proportion of patients not undergoing re-treatment procedure. Follow-up evaluations were performed at 3 and 6 months. RESULTS: The percentage of Enteryx-treated patients achieving a > or =50% reduction in PPI use (81%) was greater than that of the sham group (53%), with a rate ratio of 1.52 (confidence interval [CI], 1.06-2.28; P=.023). A higher proportion of the Enteryx (68%) than sham group (41%) ceased PPI use completely (rate ratio, 1.67; CI, 1.03-2.80; P=.033). GERD health-related quality of life heartburn score improvement > or =50% was achieved by 67% of the Enteryx group versus 22% of the sham group (rate ratio, 3.05; CI, 1.55-6.33; P <.001). More Enteryx-treated (81%) than sham-treated (19%) patients did not undergo re-treatment (rate ratio, 4.33; CI, 2.23-9.29; P <.001). CONCLUSIONS: Enteryx implantation more effectively reduces PPI dependency and alleviates GERD symptoms than a sham procedure.

Adult↗
PubMed2004

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↗
PubMed2004

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↗
PubMed2004

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↗
PubMed2004

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↗