The need for a prophylactic gastrojejunostomy for unresectable XXXX : a prospective randomized multicenter trial with special focus on assessment of quality of life.

@entity1 @entity5 @entity189 @entity260 @entity344 @entity1084 @entity3 @entity356
OBJECTIVE: To evaluate the effect of a prophylactic gastrojejunostomy on the development of @entity1084 and quality of life in @entity1 with unresectable @entity5 found during explorative laparotomy. SUMMARY BACKGROUND DATA: Several studies, including one randomized trial, propagate to perform a prophylactic gastrojejunostomy routinely in @entity1 with @entity5 found to be unresectable during laparotomy. Others suggest an @entity260 . Controversy still exists in general surgical practice if a double bypass should be performed routinely in these @entity1 . METHODS: Between December 1998 and March 2002, @entity1 with a @entity189 who were found to be unresectable during exploration were randomized to receive a double bypass (hepaticojejunostomy and a retrocolic gastrojejunostomy) or a single bypass (hepaticojejunostomy). Randomization was stratified for center and presence of @entity3 . @entity1 with @entity344 and @entity1 treated endoscopically for more than 3 months were excluded. Primary endpoints were development of clinical @entity1084 and surgical intervention for @entity1084 . Secondary endpoints were mortality, morbidity, hospital stay, survival, and quality of life, measured prospectively by the EORTC-C30 and Pan26 questionnaires. It was decided to perform an interim analysis after inclusion of 50% of the @entity1 (n = 70). RESULTS: Five of the 70 @entity1 randomized were lost to follow-up. From the remaining 65 @entity1 , 36 @entity1 underwent a double and 29 a single bypass. There were no differences in @entity1 demographics, preoperative symptoms, and surgical findings between the groups. Clinical symptoms of @entity1084 were found in 2 of the 36 @entity1 (5.5%) with a double bypass, and in 12 of the 29 @entity1 (41.4%) with a single bypass (P = 0.001). In the double bypass group, one @entity1 (2.8%) and in the single bypass group 6 @entity1 (20.7%) required (re-)gastrojejunostomy during follow-up (P = 0.04). The absolute risk reduction for reoperation in the double bypass group was 18%, and the numbers needed to treat was 6. Postoperative morbidity rates, including delayed @entity356 , were 31% in the double versus 28% in the single bypass group (P = 0.12). Median postoperative length of stay was 11 days (range 4-76 days) in the double versus 9 days (range 6-20 days) in the single bypass group (P = 0.06); median survival was 7.2 months in the double versus 8.4 months in the single bypass group (P = 0.15). No differences were found in the quality of life between both groups. After surgery most quality of life scores deteriorated temporarily and were restored to their baseline score (t = -1) within 4 months. CONCLUSIONS: Prophylactic gastrojejunostomy significantly decreases the incidence of @entity1084 without increasing complication rates. There were no differences in quality of life between the two groups. Together with the previous randomized trial from the Hopkins group, this study provides sufficient evidence to state that a double bypass consisting of a hepaticojejunostomy and a prophylactic gastrojejunostomy is preferable to a single bypass consisting of only a hepaticojejunostomy in @entity1 undergoing surgical palliation for unresectable @entity189 . Therefore, the trial was stopped earlier than planned.
