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(TJDBPS01): Study Protocol for a Multicenter Randomized Controlled Trial Total laparoscopic pancreaticoduodenectomy versus open pancreaticoduodenectomy (TJDBPS01): study protocol for a multicenter randomized controlled trial. Hang Zhang1, Junfang Zhao1, Yechen Feng1, Rufu Chen2, Xuemin Chen3, Wei Cheng4, Dewei Li5, Jingdong Li6, Xiaobing Huang7, Heguang Huang13, Deyu Li14, Jing Li7, Jianhua Liu8, Jun Liu9, Yahui Liu10, Zhijian Tan11, Xinmin Yin4, Wenxing Zhao12, Yahong Yu1, Min Wang1✉, Renyi Qin1 ✉. Minimally Invasive Pancreas Treatment Group in the Pancreatic Disease Branch of China’s International Exchange and Promotion Association for Medicine and Healthcare. 1 Department of Biliary–Pancreatic Surgery, Affiliated Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China. 2 Department of Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou 510120, China. 3 Department of Pancreaticobiliary Surgery, The Third Affiliated Hospital of Soochow University, Jiangsu 213000, China. 4 Department of Hepatobiliary Surgery, Hunan Provincial People’s Hospital, The First Affiliated Hospital of Hunan Normal University, Changsha, Hunan 410000, China. 5 Department of Hepatobiliary Surgery, First Affiliated Hospital of Chongqing Medical University, Chongqing 404100, China. 6 Department of Pancreatico-Hepatobiliary Surgery, Affiliated Hospital of North Sichuan Medical College, Sichuan 637000, China. 7 Department of Pancreatico-Hepatobiliary Surgery, The Second Affiliated Hospital, Army Medical University, PLA, Chongqing 404100, China. 8 Department of Hepato–Pancreato–Biliary Surgery, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei 050017, China. 9 Department of Hepato–Pancreato–Biliary Surgery, Shandong Provincial Hospital, Shandong 250000, China. 10 Department of Hepatobiliary and Pancreatic Surgery, The First Hospital of Jilin University, 71 Xinmin Street, Changchun, Jilin 130021, China. 11 Department of Hepatobiliary and Pancreatic Surgery, Guangdong Province Hospital of Chinese Medicine, Guangzhou, Guangdong 510120, China. 12 Department of General Surgery, The Affiliated Hospital of Xuzhou Medical College, Xuzhou, 221004, China. 13 Department of Hepato–Pancreato–Biliary Surgery, Fujian Medical University Union Hospital， Fuzhou，Fujian，350000，China. 14 Department of Hepatobiliary Pancreatic Surgery, People’s Hospital of Zhengzhou University, Henan Provincial People’s Hospital, No.7 Wei Wu Road, Zhengzhou, Henan, 450003, China. Email address for authors: [email protected] for Hang Zhang, [email protected] for Junfang Zhao, [email protected] for Yechen Feng, [email protected] for Rufu Chen, [email protected] for Xuemin Chen, [email protected] for Wei Cheng, [email protected] for Menghua Dai, [email protected] for Dewei Li, [email protected] for Jingdong Li, [email protected] for Defei Hong, [email protected] for Xiaobing Huang, [email protected] for Heguang Huang, [email protected] for Deyu Li, [email protected] for Jing Li, [email protected] for Jianhua Liu, [email protected] for Jun Liu, [email protected] for Yahui Liu, [email protected] for Zhijian Tan, [email protected] for Xinmin Yin, [email protected] for Wenxing Zhao, [email protected] for Yahong Yu. ✉Corresponding author Renyi Qin, MD Department of Biliary–Pancreatic Surgery, Affiliated Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Ave, Wuhan, Hubei 430030, China. Tel.: +27-8366-5294; Fax: +27-8366-5294 Email: [email protected] Min Wang, MD Department of Biliary–Pancreatic Surgery, Affiliated Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Ave, Wuhan, Hubei 430030, China. Tel.: +27-8366-5294; Fax: +27-8366-5294 Email: [email protected]. Abstract Background: Pancreatoduodenectomy (PD) is one of the most complex abdominal operations, usually performed for tumors of the periampullary region and chronic pancreatitis. 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: TJDBPS01 is a multicenter prospective, randomized controlled, parallel-group, superiority trial in centers with pancreatic surgery expertise who have performed ≥104 TLPDs and OPDs, respectively. A total of 630 patients underwent PD will be randomly allocated to the TLPD group or OPD group with an enhanced recovery after surgery (ERAS) pattern. The trial hypothesis is that TLPD has superiority or equivalent in safety and advantages in postoperative recoveries compared with OPD. The primary outcome variable is the estimated blood loss in the surgical procedure. Discussion: Despite the fact there are several RCTs comparing TLPD and OPD, this trial will be the first comparing TLPD and OPD in a large multicenter setting. Trial registration: Clinical Trials Register, NCT03138213. Registered on 28 Apr 2017. Keywords: pancreaticoduodenectomy, laparoscopic surgery, open surgery, whipple, randomized controlled trial. Protocol version: TJDBPS01 1.0, date: 20 Mar, 2018 Funding: This study was supported by grants from The National Natural Science Foundation of China (81272659, 81772950, 81773160), HUBEI Natural Science Foundation (WJ2017Z010). Background Pancreatic cancer constitutes a major health problem and is dreadful affair worldwide. By some estimates, it is the ninth most common cancer in United States, yet also the fourth leading cause of cancer death [1]. Surgery is the primary treatment for patients with resectable disease. Pancreaticoduodenectomy (PD) is one of the most complex abdominal operations, involving removal of the head of pancreas, duodenum and common bile duct, and is usually performed for treatment of pancreatic cancer and relieving pain in chronic pancreatitis [2]. Introduced by Gagner et al, who performed the first laparoscopic pancreaticoduodenectomy (LPD) in 1994, the use of laparoscopy in pancreas surgery has continued to grow and rapidly spread because of its potential technical advantages, such as the precision of movements achieved using laparoscopic instruments and a three-dimensional view provided by the special vision system [3]. To date, many studies confirmed the advantages of laparoscopic techniques in gastric, renal and cervical surgeries [4-6]. However, only few low-quality studies reported the application of total laparoscopy in pancreas surgery, let alone in PD surgery. In particular, recently performed meta-analyses have been poor due to the small number of studies with good quality [7-10]. However, several limitations must be highlighted among these studies including the different nature of these surgical approaches, the different baseline characteristics of each study’s patients, the relatively small sample sizes for individual study, the high heterogeneity of data, the lack of basic features regarding the procedures, such as the detailed type of surgical reconstruction, and the inadequate or non-accessibility of data regarding both the short-term outcomes and the oncological follow-up. Similarly, all of the studies that reported results in this topic emphasize the need for large randomized trials. However, RCTs are difficult to perform and are very costly. There should be further consideration regarding the need for the detection of numerous surgical, clinical and oncological variables. Thus, it is imperative for such a study to have a large number of patients enrolled. A study recruiting sufficient patients is desirable. Therefore, this project, namely TJDBPS01 trial, a large registry will be created by collecting data from the fourteen qualified centers in China to create a working basis for analyzing outcomes of interest and obtaining evidence in comparing TLPD and OPD. Rationale for the trial In recent years, TLPD is emerging and plays a rising role in compare with the OPD due to the improvement of both the surgeons’ technique and the surgical instruments. It is widely reported that the TLPD was associated with a reduction in estimated blood loss (EBL), a lower transfusion rate and a shorter length of hospital stay than OPD group. Meanwhile TLPDs have much longer operative time than OPD. Finally, there were no significant differences between the 2 procedures in major complications, mortality. Not only many retrospective studies and meta-analyses, but also several RCTs have been working on this specified topic. Palanivelu et al published the worldwide first RCT and concluded that LPD offered a shorter hospital stay comparing with OPD [11]. Poves came up with the same conclusion in the following year [12]. Both of their studies are in a single center setting and recruit only 60 and 66 patients in their trials, respectively. The researchers claimed a multicenter trial is of necessity. There it comes the LEOPARD-2, the first multicenter RCT, recruiting 99 patients didn’t reveal the superiority of the TLPD, and ceased with an estimated mortality rate of 6%, where 5 patients died in laparoscopic group and 1 patient died in the open group [13]. This result limited the application of TLPD and hindered the development of the technique through the Netherland. Therefore, a multicenter setting
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