Laparoscopic versus open pancreaticoduodenectomy for pancreatic ductal adenocarcinoma: study protocol for a multicentre randomised controlled trial
Min Wang,
Jing Li,
Jun Liu,
Feng Zhu,
Xianjun Yu,
Hang Zhang,
Xuemin Chen,
Dewei Li,
Jingdong Li,
Jianhua Liu,
Yahui Liu,
Wenxing Zhao,
Renyi Qin,
Shutao Pan,
Tingting Qin,
Taoyuan Yin
Affiliations
Min Wang
Key Lab of Visual Damage and Regeneration & Restoration of Chongqing, Chongqing, China
Jing Li
Department of Acupuncture and Moxibustion, Yueyang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China
Jun Liu
Department of Epidemiology, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases, Beijing, China
Feng Zhu
Department of Biliary–Pancreatic Surgery, Affiliated Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
Xianjun Yu
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center, Shanghai, China
Hang Zhang
1 Department of Biliary-Pancreatic Surgery, Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China
Xuemin Chen
4 Department of Pancreaticobiliary Surgery, Third Affiliated Hospital of Soochow University, Changzhou, Jiangsu, China
Dewei Li
6 Department of Hepatobiliary Surgery, Chongqing Medical University First Affiliated Hospital, Chongqing, Sichuan, China
Jingdong Li
7 Department of Pancreatico-Hepatobiliary Surgery, Affiliated Hospital of North Sichuan Medical College, Nanchong, Sichuan, China
Jianhua Liu
1 The Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University, Wuhan, Hubei, China
Yahui Liu
Department of Hepatobiliary and Pancreatic Surgery, Jilin University First Hospital, Changchun, Jilin, China
Wenxing Zhao
13 Department of Hepato–Pancreato–Biliary Surgery, Xuzhou Medical College Affiliated Hospital, Xuzhou, Jiangsu, China
Renyi Qin
1 Department of Biliary-Pancreatic Surgery, Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China
Shutao Pan
Department of Biliary–Pancreatic Surgery, Affiliated Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
Tingting Qin
Department of Biliary–Pancreatic Surgery, Affiliated Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
Taoyuan Yin
Department of Biliary–Pancreatic Surgery, Affiliated Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
Introduction Pancreatic cancer is one of the deadliest cancers and pancreaticoduodenectomy (PD) is recommended as the optimal operation for resectable pancreatic head cancer. Minimally invasive surgery, which initially emerged as hybrid-laparoscopy and recently developed into total laparoscopy surgery, has been widely used for various abdominal surgeries. However, controversy persists regarding whether laparoscopic PD (LPD) is inferior to open PD (OPD) for resectable pancreatic ductal adenocarcinoma (PDAC) treatment. Further studies, especially randomised clinical trials, are warranted to compare these two surgical techniques.Methods and analysis The TJDBPS07 study is designed as a prospective, randomised controlled, parallel-group, open-label, multicentre noninferiority study. All participating pancreatic surgical centres comprise specialists who have performed no less than 104 LPDs and OPDs, respectively. A total of 200 strictly selected PD candidates diagnosed with PDAC will be randomised to receive LPD or OPD. The primary outcome is the 5-year overall survival rate, whereas the secondary outcomes include overall survival, disease-free survival, 90-day mortality, complication rate, comprehensive complication index, length of stay and intraoperative indicators. We hypothesise that LPD is not inferior to OPD for the treatment of resectable PDAC. The enrolment schedule is estimated to be 2 years and follow-up for each patient will be 5 years.Ethics and dissemination This study received approval from the Tongji Hospital Ethics Committee of Tongji Medical College, Huazhong University of Science and Technology, and monitor from an independent third-party organisation. Results of this trial will be presented in international meetings and published in a peer-reviewed journal.Trial registration number NCT03785743.
