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Khirurgii

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Year 2009 Vol. 17 No 4

RESERCH

EGOROV V.I., SCHASTNY A.T., VISHNEVSKY V.A., SHEVCHENKO T.V., LYARSKY S.P., YASHINA N.I., VINOKUROVA L.V., PETROV R.V., SYATKOVSKY A.R., ZHAVORONKOVA O.I., MELEKHINA O.V.

TWO-CENTRAL RANDOMIZING CONTROLLED RESEARCH «COMPARATIVE ESTIMATION OF THE RESULTS OF DUODENUM-SAVING SUBTOTAL PANCREAS HEAD RESECTION WITH AND WITHOUT THE LONGITUDINAL PANCREATICOENTEROANASTOMOSIS AT CHRONIC PANCREATITIS WITH THE WIDENING OF THE MAIN PANCREATIC DUCT AT STRICTURES AND CALCULI ABSENCE IN ITS LUMEN»

Chronic pancreatitis (CP) is an inflammatory disease characterized by irreversible replacement of the pancreatic parenchyma with the fibrous tissue. In the majority of CP patients the pancreas head is a trigger of the chronic inflammation; that’s why the pancreas head tissue resection is becoming the central part of the surgical intervention. The role of the duct drainage of the remained part of the pancreas for providing prolonged anesthetic effect and maximal high quality of life is still unclear.
Design. Two-central randomizing controlled research “Comparative estimation of the results of duodenum-saving subtotal pancreas head resection with and without the longitudinal pancreaticoenteroanastomosis at chronic pancreatitis with the widening of the main pancreatic duct at strictures and calculi absence in its lumen. 44 patients will be included and intraoperatively randomized. The choice criteria: all patients with CP with indications for pancreas head resection, who signed the informed consent.
Comparable interventions:
1. subtotal duodenum-saving resection of the pancreas head without its intersection (Bern’s variant of the Beger’s operation)
2. subtotal duodenum-saving resection of the pancreas head without its intersection (Bern’s variant of the Beger’s operation) with the longitudinal pancreaticoenteroanastomosis
Combined main ultimate point (hierarchic model): the duration of the operation, the life quality in one year after the operation, duration of stay at the reanimation unit, duration of hospitalization.
Duration: September, 2009 – October, 2012
Organization and responsibility: the research is organized in accordance to the moral, ethical, regulating and scientific principles of clinical researches realization according to the Declaration of Helsinki, 1989 and the Rules of conscientious clinical practice. The subjects responsible for the planning, conducting and final analysis of the research are “A.V. Vishnevsky institute of surgery” , Moscow, Russia (Egorov V.I.) and Vitebsk regional scientific-practical center of the liver and pancreas diseases, Vitebsk, the Republic of Belarus (Schastny A.T.)

Keywords: chronic pancreatitis, operative treatment, pancreas head resection, two-central randomizing controlled research
p. 172 – 182 of the original issue
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