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Comparing Laparoscopic and Open Surgery for Pancreatic Carcinoma

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研究单位: [1]Tongji Hospital [2]Shandong Provincial Hospital [3]The Second Hospital of Hebei Medical University [4]The Affiliated Hospital of Xuzhou Medical University [5]Xinqiao Hospital of Chongqing [6]Hunan Provincial People's Hospital [7]The First Hospital of Jilin University [8]Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University [9]The Third Affiliated Hospital of Soochow University [10]Guangdong Provincial Hospital of Traditional Chinese Medicine [11]Affiliated Hospital of North Sichuan Medical College [12]First Affiliated Hospital of Chongqing Medical University [13]Peking Union Medical College Hospital [14]Henan Provincial People's Hospital [15]Sir Run Run Shaw Hospital [16]Fujian Medical University Union Hospital [17]Fudan University

关键词: Pancreatic Carcinoma Laparoscopic Pancreaticoduodenectomy Survival

研究目的:
Background: Pancreatic cancer (PC) is one of the most aggressive malignant neoplasms with poor outcomes. Pancreatoduodenectomy (PD) is the only curative treatment for PC. Minimally invasive surgery has been progressively developed, first with the advent of hybrid-laparoscopy and recently with the total laparoscopy surgeries, but a number of issues are currently being debated, including the superiority between total laparoscopic pancreaticoduodenectomy (TLPD)and the open pancreaticoduodenectomy (OPD). Studies comparing these two surgery techniques are merging and randomized controlled trials (RCT) are lacking but clearly required. Methods/design: TJDBPS07 is a multicenter prospective, randomized controlled, trial comparing TLPD and OPD in pancreatic cancers. A total of 200 patients with pancreatic cancer underwent PD will be randomly allocated to the TLPD group or OPD group with an enhanced recovery after surgery (ERAS) pattern. The trial's aim is to exploring the overall survival (OS), disease free survival (DFS) and quality of life. The duration of the entire trial is seven years including prearrangement, a presumably five-year follow-up and analyses. Discussion: Despite the fact there are several RCTs comparing minimally invasive pancreaticoduodenectomy (MIPD) and Open approach or LPD versus OPD. This trial will be the first comparing TLPD and OPD in a large multicenter setting. TJDBPS01 trial is hypothesized to assess whether TLPD has superiority over OPD in recovery and other aspects.

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