%0 Journal Article
%T LigaSure Impact£¿ versus conventional dissection technique in pylorus-preserving pancreatoduodenectomy in clinical suspicion of cancerous tumours on the head of the pancreas: study protocol for a randomised controlled trial
%A Tobias Gehrig
%A Phillip Knebel
%A Verena Scheel
%A Ulf Hinz
%A Christoph M Seiler
%A Beat P M¨¹ller-Stich
%A Markus W B¨¹chler
%A Carsten N Gutt
%J Trials
%D 2011
%I BioMed Central
%R 10.1186/1745-6215-12-162
%X A single-center, randomized, single-blinded, controlled superiority trial to compare two different techniques for dissection in a pp-Whipple procedure. 102 patients will be included and randomized pre-operatively. All patients aged 18 years or older scheduled for primary elective pp-Whipple procedure who signed the informed consent will be included. The primary endpoint is the operating time of the randomized technique. Control Intervention: Conventional dissection technique; experimental intervention: LigaSureTM dissection technique. Duration of study: Approximately 15 months; follow up time: 3 years. The trial is registered at German ClinicalTrials Register (DRKS00000166).The procedure was originally described by Alessandro Codivilla in 1898, A.O. Whipple improved it in 1935. The Whipple procedure is the standard method for therapy of cancerous tumours, inflammation and stenosis near the head of the pancreas. In the classic Whipple-procedure (c-Whipple) the head of the pancreas, the duodenum, the regional lymph nodes, the gastric antrum, the gallbladder, and the distal bile duct are removed. The pylorus-preserving-Whipple procedure (pp-Whipple) was established by Traverso and Longmire in 1978. During this procedure the gastric antrum is not removed. In recent years the pp-Whipple procedure is preferred because several studies have shown that the classic Whipple procedure is not superior to the pp-Whipple procedure regarding the oncological outcome or peri- and postoperative complication rates [1-5].About 300 patients are operated on following the pp-Whipple procedure at the department each year. As the pancreas is fed by many vessels [6], it is necessary to use lots of ligatures, clips and sutures for hemostasis after dissection. This dissection technique is very time-consuming and requires numerous changes of instruments. The use of high-frequency feedback-controlled electrothermal bipolar vessel sealant technology, known as the LigaSure£¿ Vessel Sealing System (L
%U http://www.trialsjournal.com/content/12/1/162