LigaSure ImpactTM 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

Background: The pp-Whipple procedure requires extensive preparation. The conventional preparation technique is done with scissors for dissection and ligatures, and with clips and sutures for hemostasis. This procedure is very time-consuming and requires numerous changes of instruments. The LigaSureTM device allows dissection and hemostasis for preparation with one instrument. Up to now there has been no comparison of the two techniques with regard to operating time and the patients’ outcome. It is still unclear which technique has the optimal benefit/risk ratio for the patient. Methods/Design: 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 preoperatively. 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). Background 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 ppWhipple procedure regarding the oncological outcome or periand postoperative complication rates [1-5]. About 300 patients are operated on following the ppWhipple 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 timeconsuming and requires numerous changes of instruments. The use of high-frequency feedback-controlled electrothermal bipolar vessel sealant technology, known as the LigaSureTM Vessel Sealing System (LVSS), is a new alternative for dissection and hemostasis. The bipolar vessel dissection devices require no * Correspondence: [email protected] Department of General, Abdominal and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany Full list of author information is available at the end of the article Gehrig et al. Trials 2011, 12:162 http://www.trialsjournal.com/content/12/1/162 TRIALS © 2011 Gehrig et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. change of instruments for dissection and hemostasis [7-10]. The current is provided by a special HF-generator and contains a very high capacity with a low voltage. The body’s proteins, such as collagen and elastin, are converted so a permanently sealed zone results. As only the tissue between the branches is sealed, lateral thermic tissue damages can be limited to a minimum. Several authors describe a tendency of reduced intraoperative blood loss and transfused blood preservations [11-13]. Other trials show reduced operating time using the LVSS in several surgical procedures, such as thyroid, gynecology, urology and haemorrhoidectomy surgery [9,11,13,14]. Correct dissection in the operation field is very important to avert secondary bleeding or other complications, which might cause re-operation or elevate the patients’ morbidity and mortality [15].