Abstract
BackgroundChronic pancreatitis is an inflammatory disease which is characterized by an irreversible conversion of pancreatic parenchyma to fibrous tissue. Beside obstructive jaundice and pseudocyst formation, about half of the patients need surgical intervention due to untreatable chronic pain during the course of the disease. In most of the patients with chronic pancreatitis, the head of the pancreas is the trigger of the chronic inflammatory process. Therefore, resection of pancreatic head tissue must be the central part of any surgical intervention. However, it is unclear to which extent the surgical procedure must be radical in order to obtain a favourable outcome for the patients.DesignA single centre randomized controlled, superiority trial to compare two techniques of duodenum preserving pancreatic head resection. Sample size: 65 patients will be included and randomized intraoperatively. Eligibility criteria: All patients with chronic pancreatitis and indication for surgical resection and signed informed consent. Cumulative primary endpoint (hierarchical model): duration of surgical procedure, quality of life after one year, duration of intensive care unit stay, duration of hospital stay. Reference treatment: Resection of the pancreatic head with dissection of the pancreas from the portal vein and transsection of the gland (Beger procedure). Intervention: Partial Resection of the pancreatic head without transsection of the organ and visualization of the portal vein (Berne procedure).Duration: September 2003-October 2007.Organisation/responsibilityThe trial is conducted in compliance with the protocol and in accordance with the moral, ethical, regulatory and scientific principles governing clinical research as set out in the Declaration of Helsinki (1989) and the Good Clinical Practice guideline (GCP). The Center for Clinical Studies of the Department of Surgery Heidelberg is responsible for planning, conducting and final analysis of the trial.
Highlights
Chronic pancreatitis is an inflammatory disease which is characterized by an irreversible conversion of pancreatic parenchyma to fibrous tissue
Despite of the fact that the etiopathogenesis of pain in chronic pancreatitis is not fully understood, the concept of a neuroimmune interaction in the head of the pancreas is in accordance with the observation that simple drainage procedures seldom lead to satisfactory pain relief in the long run in patients with an enlarged pancreatic head [26]
Surgical techniques that include resection of the inflammatory mass in the pancreatic head have shown to be successful in the treatment of this disease [7,8]
Summary
Medical problem Chronic pancreatitis is an inflammatory disease, which is characterized by progressive and irreversible destruction of pancreatic parenchyma and transformation into fibrous tissue. Beger for the first time described the technique of duodenum preserving pancreatectomy in the treatment of patients with chronic pancreatitis (Fig. 1) [9,10] The rationale of this intervention is the resection of the inflammatory mass in the pancreatic head without. To combine the advantages of the original Beger procedure with the Frey technique, we developed an additional modification which consists in a duodenum preserving resection of the pancreatic head in analogy to the original Beger technique, with the difference that a small shape of pancreatic tissue remains on the anterior wall of the portal vein in a way that the hazardous division of vein and pancreatic body is avoided (Fig. 2) [17]. Reconstruction after duodenum preserving pancreatic head resection with a Roux en-Y jejunal loop as side-to-end and side-to-side pancreatico-jejunostomy
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