Rabenstein, Thomas and Fischer, Bernhard and Wiessner, Volkmar and Schmidt, Harald and Radespiel-Troeger, Martin and Hochberger, Jürgen and Muehldorfer, Steffen and Nusko, Gerhard and Messmann, Helmut and Schoelmerich, Juergen and Schulz, Hans-Joachim and Schoenekaes, Herbert and Hahn, Eckhart Gustav and Schneider, Hans Thomas (2004) Low-molecular-weight heparin does not prevent acute post-ERCP pancreatitis. GASTROINTESTINAL ENDOSCOPY, 59 (6). pp. 606-613. ISSN 0016-5107
Full text not available from this repository.Abstract
Background: Studies suggest that heparin has anti-inflammatory effects that could prevent acute post-ERCP pancreatitis. The aim of this investigator-initiated, prospective, randomized, double-blind, multicenter study was to determine whether low-molecular-weight heparin can prevent acute post-ERCP pancreatitis. Methods: Patients at increased risk for acute post-ERCP pancreatitis based on assessment of known risk factors were randomized to receive low-molecular-weight heparin (Certoparin 3000 IU subcutaneously) or placebo (saline solution 0.3 mL subcutaneously) the day before ERCP. The drug was given 2 hours before and 22 hours after ERCP. Documentation and follow-up included patient history, risk factors for acute post-ERCP pancreatitis, procedure-related data, assessment of pain (visual analogue scale, need for pain medication), laboratory findings before and after ERCP (0, 4, and 24 hours), as well as post-ERCP complications. The two-sided Fisher exact test was used for statistical comparison, and a p value less than or equal to0.05 was considered significant. Results: A total of 458 patients were enrolled in the study. Data from 10 patients could not be evaluated, leaving 221 patients in the low-molecular-weight heparin group and 227 in the placebo group (total 448 patients; 135 men, 313 women; mean age 58 [15] years). Low-molecular-weight heparin and placebo groups were comparable with regard to risk factors for acute post-ERCP pancreatitis (gender distribution, age <65 years, history of pancreatitis, pancreas divisum, disorders of sphincter of Oddi) and procedure-related data (difficult cannulation, diagnostic or therapeutic ERCP, needle-knife papillotomy, endoscopic sphincterotomy, biliary or pancreatic procedure, pancreatic contrast injection, success and final diagnosis of ERCP). Acute post-ERCP pancreatitis occurred in 8.5% (38/448), with one death resulting from severe pancreatitis. Low-molecular-weight heparin offered no benefit compared with placebo based on the frequency of acute post-ERCP pancreatitis (low-molecular-weight heparin, 18/221 vs. placebo, 20/227; p = 0.87) and the severity of acute post-ERCP pancreatitis (low-molecular-weight heparin, 14 mild, 3 moderate, one severe; placebo, 18 mild, two moderate, 0 severe). The 24-hour serum amylase values and 24-hour pain scores did not differ significantly between the low-molecular-weight heparin group and the placebo group. Bleeding complications occurred in two patients, both in the low-molecular-weight heparin group (one mild, one moderate). Conclusions: Prophylactic subcutaneous administration of low-molecular-weight, heparin does not prevent acute post-ERCP pancreatitis.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY; SPHINCTEROTOMY-INDUCED PANCREATITIS; NONDILATED BILE-DUCTS; ODDI DYSFUNCTION; BILIARY SPHINCTEROTOMY; RISK-FACTORS; PROSPECTIVE MULTICENTER; THERAPEUTIC ERCP; STENT PLACEMENT; COMPLICATIONS; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin I |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 20 Jul 2021 10:09 |
| Last Modified: | 20 Jul 2021 10:09 |
| URI: | https://pred.uni-regensburg.de/id/eprint/37685 |
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