Randomizirano dvostruko-slijepo ispitivanje učinkovitosti oktreotid acetata u sprječavanju abdominalne boli nakon terapijske endoskopske retrogradne kolangiopankreatografije

Abstract

Abdominal pain is a complication of endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic sphincterotomy (EST). The aim of this trial was to investigate the effects of octreotide acetate in the prevention of abdominal pain in patients undergoing therapeutic ERCP. A double-blind study was carried out in 209 subjects who were randomly allocated to two groups (A and B). Group A (104 patients) received 0.5 mg of octreotide acetate subcutaneously one hour prior to ERCP; and group B (105 patients) were given placebo. Patients were assessed 2 and 24 hours following endoscopy for the following parameters: presence and character of abdominal pain, requirements of analgetics. Thirty-nine (18%) patients complained of post-ERCP pain, i.e. ten in group A and 29 in group B, all of them treated with analgetics. Of the ten group A patients, symptoms of acute pancreatitis were identified in four (3.85%) patients versus ten (9.52%) patients in the control group B. The results obtained in the study seem to indicate that octreotide pretreatment significantly reduced the development of post-ERCP pain.Abdominalna bol je česta komplikacija endoskopske retrogradne kolangiopankreatografije (ERCP) i endoskopske sfinkterotomije (EST). Cilj ovoga ispitivanja bio je istražiti učinke oktreotid acetata u prevenciji abdominalne boli u bolesnika podvrgnutih ERCP-u. U ovu dvostruko-slijepu studiju bilo je uključeno 209 bolesnika koji su nasumce podijeljeni u dvije skupine (A i B). Bolesnici skupine A (n=104) primili su 0,5 mg oktreotid acetata supkutano jedan sat prije ERCP-a, dok su bolesnici skupine B (n=105) dobili placebo. Procjena kliničkih parametara (prisutnost i težina abdominalne boli te potreba za analgeticima) provedena je u bolesnika 2 i 24 sata nakon endoskopije. Ukupno se 39 (18%) bolesnika žalilo na bol nakon ERCP-a, tj. desetoro u skupini A i 29 u skupini B, a svi su oni liječeni analgeticima. Od desetoro bolesnika iz skupine A simptomi akutnog pankreatitisa zabilježeni su u četvoro (3,85%) bolesnika, u usporedbi s desetoro (9,52%) bolesnika u kontrolnoj skupini B. Rezultati ovoga ispitivanja pokazali su da je prethodno davanje oktreotida značajno smanjilo nastup abdominalne boli nakon ERCP-a