Efficacy and safety of early pancreatic duct stenting for unresectable pancreatic cancer: A randomized controlled trial

早期胰管支架置入术治疗不可切除胰腺癌的疗效和安全性:一项随机对照试验

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Abstract

BACKGROUND: Palliative care for unresectable pancreatic cancer (PC) focuses mainly on the symptoms of the disease, including abdominal pain, obstructive jaundice, and malnutrition. Biliary stent placement using endoscopic retrograde cholangiopancreatography (ERCP) to relieve biliary obstruction has become an internationally recognized treatment. Although a few studies have evaluated the efficacy of endoscopic pancreatic duct stenting in advanced PC, no consensus exists on the use of endoscopic treatment to relieve pain and improve nutritional status. AIM: To evaluate the efficacy and safety of early pancreatic duct stenting in patients with unresectable PC. METHODS: Patients with unresectable PC were recruited. The participants were randomized into two groups: The double-stent group underwent ERCP with a fully-covered self-expandable metallic biliary stent (FCSEMS) and a pancreatic duct stent, while the single-stent group underwent ERCP with an FCSEMS only. Abdominal pain, nutritional status, and incidence of adverse events were compared between the two groups using the SPSS software. RESULTS: Seventy-eight patients with unresectable PC were included in the analysis (40 and 38 in the double- and single-stent groups, respectively). The median pain scores of patients in the double-stent group were lower than those in the single-stent group at 1 (0 vs 2.5, P = 0.002), 2 (0 vs 3, P < 0.001), 3 (0 vs 4, P < 0.001), and 6 months (0 vs 4, P < 0.001) after ERCP. Total serum protein levels in patients in the double-stent group were higher than those in the single-stent group (66.6 ± 8.4 g/L vs 60.4 ± 4.0 g/L, P = 0.046) 6 months postoperatively. The body mass index (BMI) of patients in both groups decreased at six months. However, the BMI in the single-stent group was higher than that in the double-stent group (P < 0.001). CONCLUSION: Early pancreatic duct stenting reduces abdominal pain and improves nutritional status in patients with unresectable PC without reducing the technical success rate or increasing the incidence of adverse events.

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