Comparison of Two Dosing Regimens of Gabexate in the Prophylaxis of Post-ERCP Pancreatitis

Enzo Masci, Giorgio Cavallini, Alberto Mariani, Luca Frulloni, Pier Alberto Testoni, Simona Curioni, Alberto Tittobello, Generoso Uomo, Guido Costamagna, Sandro Zambelli, Gianpiero Macarri, Paolo Innocenti, Carola Dragonetti

Research output: Contribution to journalArticle

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Abstract

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.

Original languageEnglish
Pages (from-to)2182-2186
Number of pages5
JournalAmerican Journal of Gastroenterology
Volume98
Issue number10
DOIs
Publication statusPublished - Oct 2003

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Gabexate
Endoscopic Retrograde Cholangiopancreatography
Pancreatitis
Pain
Incidence
Amylases
Lipase
Intravenous Infusions
Sodium Chloride
Analgesics
Placebos

ASJC Scopus subject areas

  • Gastroenterology

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Comparison of Two Dosing Regimens of Gabexate in the Prophylaxis of Post-ERCP Pancreatitis. / Masci, Enzo; Cavallini, Giorgio; Mariani, Alberto; Frulloni, Luca; Alberto Testoni, Pier; Curioni, Simona; Tittobello, Alberto; Uomo, Generoso; Costamagna, Guido; Zambelli, Sandro; Macarri, Gianpiero; Innocenti, Paolo; Dragonetti, Carola.

In: American Journal of Gastroenterology, Vol. 98, No. 10, 10.2003, p. 2182-2186.

Research output: Contribution to journalArticle

Masci, E, Cavallini, G, Mariani, A, Frulloni, L, Alberto Testoni, P, Curioni, S, Tittobello, A, Uomo, G, Costamagna, G, Zambelli, S, Macarri, G, Innocenti, P & Dragonetti, C 2003, 'Comparison of Two Dosing Regimens of Gabexate in the Prophylaxis of Post-ERCP Pancreatitis', American Journal of Gastroenterology, vol. 98, no. 10, pp. 2182-2186. https://doi.org/10.1111/j.1572-0241.2003.07698.x
Masci, Enzo ; Cavallini, Giorgio ; Mariani, Alberto ; Frulloni, Luca ; Alberto Testoni, Pier ; Curioni, Simona ; Tittobello, Alberto ; Uomo, Generoso ; Costamagna, Guido ; Zambelli, Sandro ; Macarri, Gianpiero ; Innocenti, Paolo ; Dragonetti, Carola. / Comparison of Two Dosing Regimens of Gabexate in the Prophylaxis of Post-ERCP Pancreatitis. In: American Journal of Gastroenterology. 2003 ; Vol. 98, No. 10. pp. 2182-2186.
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AU - Cavallini, Giorgio

AU - Mariani, Alberto

AU - Frulloni, Luca

AU - Alberto Testoni, Pier

AU - Curioni, Simona

AU - Tittobello, Alberto

AU - Uomo, Generoso

AU - Costamagna, Guido

AU - Zambelli, Sandro

AU - Macarri, Gianpiero

AU - Innocenti, Paolo

AU - Dragonetti, Carola

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Y1 - 2003/10

N2 - 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.

AB - 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.

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