BACKGROUND:Endoscopic transmural drainage is obtained by creating a communication between the intestinal tract and the pancreatic-fluid collection, and then inserting 1 or more stents. Collection recurrence after therapy is noted in 10% to 30% of cases. It is not known whether leaving the stents in position reduces recurrence rates. OBJECTIVE: To test the hypothesis that patients who have undergone previous successful pancreatic-collection drainage and whose stents are retrieved have higher recurrence rates. DESIGN: Randomized controlled trial. SETTING: Tertiary referral center. PATIENTS: During a period of 27 months, 46 of 77 patients who had undergone endoscopic transmural drainage for pancreatic collections met inclusion or exclusion criteria, and 28 of these patients were randomized. INTERVENTIONS:Fifteen patients were assigned to group A, whose stents were left in place, and 13 were assigned to group B, whose stents were removed after collection resolution. The remaining 18 patients, who were not randomized, also had their stents left in place. All 46 patients were similarly followed. MAIN OUTCOME MEASUREMENT: Recurrence of the same pancreatic collection that required therapy. RESULTS: All patients were followed for a median period of 14 months (interquartile range, 8.2-22 months) after treatment. The primary end point was reached in 5 patients in group B (stent retrieval), as opposed to none in group A (P = .013). Moreover, no recurrence was observed in the remaining 18 nonrandomized patients. LIMITATIONS: Small sample size. CONCLUSIONS: In patients who underwent successful transmural drainage of pancreatic collections, stent retrieval was associated with higher recurrence rates.
RCT Entities:
BACKGROUND: Endoscopic transmural drainage is obtained by creating a communication between the intestinal tract and the pancreatic-fluid collection, and then inserting 1 or more stents. Collection recurrence after therapy is noted in 10% to 30% of cases. It is not known whether leaving the stents in position reduces recurrence rates. OBJECTIVE: To test the hypothesis that patients who have undergone previous successful pancreatic-collection drainage and whose stents are retrieved have higher recurrence rates. DESIGN: Randomized controlled trial. SETTING: Tertiary referral center. PATIENTS: During a period of 27 months, 46 of 77 patients who had undergone endoscopic transmural drainage for pancreatic collections met inclusion or exclusion criteria, and 28 of these patients were randomized. INTERVENTIONS: Fifteen patients were assigned to group A, whose stents were left in place, and 13 were assigned to group B, whose stents were removed after collection resolution. The remaining 18 patients, who were not randomized, also had their stents left in place. All 46 patients were similarly followed. MAIN OUTCOME MEASUREMENT: Recurrence of the same pancreatic collection that required therapy. RESULTS: All patients were followed for a median period of 14 months (interquartile range, 8.2-22 months) after treatment. The primary end point was reached in 5 patients in group B (stent retrieval), as opposed to none in group A (P = .013). Moreover, no recurrence was observed in the remaining 18 nonrandomized patients. LIMITATIONS: Small sample size. CONCLUSIONS: In patients who underwent successful transmural drainage of pancreatic collections, stent retrieval was associated with higher recurrence rates.