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Preventive effects of ulinastatin on complications related to pancreaticoduodenectomy

View Article: PubMed Central - PubMed

ABSTRACT

Postoperative pancreatic fistula (POPF) is one of the most common major complications after pancreaticoduodenectomy (PD). Ulinastatin is an intrinsic trypsin inhibitor and mainly used to treat acute pancreatitis, chronic recurrent pancreatitis, and acute circulatory failure. The study aims to investigate the efficacy of ulinastatin on pancreatic fistula and other complications after PD. This prospective, randomized, double-blind, placebo-controlled trial was conducted in West China Hospital of Sichuan University from December 2012 to December 2014. A total of 106 consecutive patients undergoing PD were randomly assigned to receive ulinastatin or placebo during and after the surgery for 5 days. Baseline clinical characteristics and outcomes of patients were recorded and analyzed. Ninety-two patients including 42 in the ulinastatin group and 50 in the placebo group were available for outcome assessment. The POPF rates were comparable between ulinastatin group (43%) and placebo group (26%), whereas the severe pancreatic fistula rate (grade B + C) was significantly less in ulinastatin group than that in placebo group (7% vs 24%, P = 0.045). For patients with small pancreatic duct diameter (≤3 mm), ulinastatin could significantly reduce the risk of POPF (P = 0.022). Ulinastatin had protective effects for patients undergoing PD on the prevention of severe postoperative pancreatic fistula.

No MeSH data available.


The flow of participant. Of 106 consecutive patients randomized, 14 patients were excluded from analysis. The study population consisted of 92 patients, 42 in the ulinastatin group and 50 in the placebo group.
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Figure 1: The flow of participant. Of 106 consecutive patients randomized, 14 patients were excluded from analysis. The study population consisted of 92 patients, 42 in the ulinastatin group and 50 in the placebo group.

Mentions: Of 106 consecutive patients enrolled from December 2012 to December 2014, 14 patients were excluded from analysis, including 8 patients who withdrew participation on their own accord, 5 patients who received ulinastatin using a different drug delivery method, and 1 patient who took other protease inhibitor during the study period. The study population consisted of 92 patients, 42 in the ulinastatin group and 50 in the placebo group (Fig. 1). There were 32 women and 60 men, with a mean age of 57 ± 12 years. The 2 groups were similar with respect to age, sex, body mass index, multiple preoperative factors, and history of smoking, alcohol intake, and abdominal surgery (Table 1).


Preventive effects of ulinastatin on complications related to pancreaticoduodenectomy
The flow of participant. Of 106 consecutive patients randomized, 14 patients were excluded from analysis. The study population consisted of 92 patients, 42 in the ulinastatin group and 50 in the placebo group.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4998438&req=5

Figure 1: The flow of participant. Of 106 consecutive patients randomized, 14 patients were excluded from analysis. The study population consisted of 92 patients, 42 in the ulinastatin group and 50 in the placebo group.
Mentions: Of 106 consecutive patients enrolled from December 2012 to December 2014, 14 patients were excluded from analysis, including 8 patients who withdrew participation on their own accord, 5 patients who received ulinastatin using a different drug delivery method, and 1 patient who took other protease inhibitor during the study period. The study population consisted of 92 patients, 42 in the ulinastatin group and 50 in the placebo group (Fig. 1). There were 32 women and 60 men, with a mean age of 57 ± 12 years. The 2 groups were similar with respect to age, sex, body mass index, multiple preoperative factors, and history of smoking, alcohol intake, and abdominal surgery (Table 1).

View Article: PubMed Central - PubMed

ABSTRACT

Postoperative pancreatic fistula (POPF) is one of the most common major complications after pancreaticoduodenectomy (PD). Ulinastatin is an intrinsic trypsin inhibitor and mainly used to treat acute pancreatitis, chronic recurrent pancreatitis, and acute circulatory failure. The study aims to investigate the efficacy of ulinastatin on pancreatic fistula and other complications after PD. This prospective, randomized, double-blind, placebo-controlled trial was conducted in West China Hospital of Sichuan University from December 2012 to December 2014. A total of 106 consecutive patients undergoing PD were randomly assigned to receive ulinastatin or placebo during and after the surgery for 5 days. Baseline clinical characteristics and outcomes of patients were recorded and analyzed. Ninety-two patients including 42 in the ulinastatin group and 50 in the placebo group were available for outcome assessment. The POPF rates were comparable between ulinastatin group (43%) and placebo group (26%), whereas the severe pancreatic fistula rate (grade B + C) was significantly less in ulinastatin group than that in placebo group (7% vs 24%, P = 0.045). For patients with small pancreatic duct diameter (≤3 mm), ulinastatin could significantly reduce the risk of POPF (P = 0.022). Ulinastatin had protective effects for patients undergoing PD on the prevention of severe postoperative pancreatic fistula.

No MeSH data available.