A multicenter prospective randomized controlled trial for preoperative biliary drainage with uncovered metal versus plastic stents for resectable periampullary cancer.

BACKGROUND/PURPOSE: Although routine preoperative biliary drainage (PBD) in patients with distal malignant biliary obstruction is generally not recommended, there are still various situations where it may be necessary. The current study aims to compare the uncovered self-expandable metal stent (uSEMS) and plastic stent (PS), where PBD may be necessary. PATIENTS AND METHODS: In this multicenter prospective randomized study, patients with resectable periampullary cancer with cholangitis, deep jaundice, or expected long waiting time for surgery were included. PBD was performed endoscopically, but percutaneous drainage was allowed if the initial endoscopic drainage was not feasible. The primary outcome was the reintervention rate; the secondary outcomes were the complication rates, rate of decrease of total bilirubin, waiting time for surgery, and postoperative hospital stay. RESULTS: Of the 60 enrolled patients, 53 were included for analysis (26 PS and 27 uSEMS). Common bile duct cancer was the most common (27, 50.9%), followed by pancreatic head cancer (20, 37.7%). Regarding PBD indication, 36 (67.9%) had cholangitis and 21 (39.6%) had a total bilirubin level of more than 10 mg/dL at randomization; 10 (18.9%) were included due to delayed surgery by more than 7 days. Fifty (94.3%) patients received pancreaticoduodenectomy, and one (1.9%) patient received palliative hepaticojejunostomy. The median waiting time for surgery was 11.0 days. There was no difference in the reintervention rate (3.8% and 3.8% in PS and uSEMS, P > .999), PBD-related complication rate (23.1% and 22.2%, P > .999), PBD- or surgery-related complication rate (57.7% and 48.1%, P = .674), and the rate of decrease of total bilirubin (P = .541). The median hospital stay after surgery was 13.0 days without significant difference. CONCLUSION: For patients who received surgery within the first 2 weeks from receiving PBD, there was no superiority of uSEMS to PS. According to the expected waiting time for surgery, selective approach for stent choice should be considered.

[Comparison among conventional 4 L polyethylene glycol, split method of 4 L polyethylene glycol and combination of 2 L polyethylene glycol and sodium phosphate solution for colonoscopy preparation].

BACKGROUND/AIMS: The aim of this study was to compare polyethylene glycol (PEG) 4 L, split method of PEG 4 L and PEG 2 L plus sodium phosphate (NaP) in the aspect of bowel preparation quality, safety, patients' compliance and preference. METHODS: Total 249 subjects were prospectively enrolled and received bowel preparation for colonoscopy from August to October in 2010; PEG 4 L (93 subjects), split method of 4 L PEG (74 subjects) and PEG 2 L plus NaP 90 mL group (82 subjects). To investigate the completion, preference for bowel preparation and safety, a questionnaire survey was conducted before colonoscopy. RESULTS: There were no significant intergroup differences in the aspect of completion of preparation, cecal intubation time and success rate. Satisfaction and preference were higher in PEG 2 L plus NaP 90 mL and split method of 4 L PEG compared with PEG 4 L. In the aspect of the bowel preparation quality PEG 4 L showed significantly higher quality in the morning colonoscopy (p<0.001). However, in the afternoon colonoscopy PEG 2 L plus NaP 90 mL showed better result than PEG 4 L (p=0.009). Hyperphosphatemia was most frequently observed in PEG 2 L plus NaP 90 mL, but no severe adverse events occurred (p<0.001). CONCLUSIONS: PEG 4 L showed better result than split method of 4 L PEG or PEG 2 L plus NaP 90 mL in the aspect of bowel preparation quality and safety.