Fully covered metal stents vs plastic stents for preoperative biliary drainage in patients with resectable pancreatic cancer without neoadjuvant chemotherapy: A multicenter, prospective, randomized controlled trial.

BACKGROUND/PURPOSE: Whether a fully covered self-expanding metal stent (FCSEMS) or plastic stent (PS) is preferable for preoperative biliary drainage in patients with resectable pancreatic cancer (RPC) is controversial. This study aimed to evaluate the safety and efficacy of drainage with FCSEMS for obstructive jaundice caused by RPC without neoadjuvant chemotherapy. METHODS: Seventy patients with RPC who required preoperative biliary drainage were randomly assigned 1:1 to the FCSEMS or PS group. The primary endpoint was endoscopic re-intervention rate during the waiting period for surgery. Secondary endpoints were drainage procedure time, drainage-related adverse events (AE), waiting period for surgery, operative time, intraoperative blood loss, surgery-related AE, and postoperative hospital stay. RESULTS: Thirty-nine patients underwent surgery. None required re-intervention in the FCSEMS group, whereas five PS patients underwent re-intervention (P = .023). The FCSEMS group had significantly more intraoperative blood loss (P = .0068) and AE (P = .011) than the PS group. Postoperative hospital stay was significantly longer in the FCSEMS group (P = .016). CONCLUSIONS: Fully covered self-expanding metal stent had a lower rate of endoscopic re-intervention during the waiting period for surgery than PS, but showed more intraoperative blood loss, higher incidence of surgery-related AE, and longer postoperative hospital stays.

Comparison of modified introducer method with pull method for percutaneous endoscopic gastrostomy: prospective randomized study.

AIM: The pull method is associated with a high incidence of percutaneous endoscopic gastrostomy (PEG) site infection. The introducer method has been shown to be less likely to cause infection, because it avoids the passage of a tube through the oropharynx. The aim of the present study was to compare the modified introducer method with the pull method for PEG. METHODS: The study included patients who were scheduled for PEG from April 2008 to April 2010. The patients were randomly assigned to receive PEG by the pull method (Group I) or the modified introducer method (Group II). We evaluated the incidence of PEG site infection, some infection-associated parameters and other complications. Wound infections were evaluated in accordance with the Jain's score. RESULTS: Of 62 patients enrolled, 31 patients were assigned to each of the two groups. One patient in Group I died on the day after PEG. The cause of death and relationship with PEG were unclear. Excluding this patient, 61 were included in the per-protocol analysis. The incidence of peristomal infection within 1 week was slightly lower in Group II than in Group I, albeit not statistically significant (12.9% vs 23.3%, P = 0.3354). White blood cell count (WBC) and C-reactive protein (CRP) levels were significantly lower in Group II (WBC: P = 0.0345, CRP: P = 0.0346). None of the patients underwent surgical procedures for the treatment of peristomal infection. CONCLUSION: The results of the present study show that gastrostomy by the modified introducer method may be less likely, although not significantly, to cause peristomal infection than the pull method.