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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
TLPD
OPD
Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITING5-year overall survival
5-year overall survival
Time frame: 5 year
overall survival
the interval between the day of surgery and the day of death for various reasons
Time frame: 5 years
disease-free survival
the interval between the day of surgery and the day of tumour recurrence
Time frame: 5 years
90-day mortality
the percentage of patients who died within 90 days postoperatively
Time frame: 90 days
complication rate
complications related to PD
Time frame: 90 days
comprehensive complication index
calculated as the sum of all complications that are weighted for their severity
Time frame: 90 days
length of stay
the number of nights spent in the hospital from the end of the surgical procedure until discharge or death
Time frame: 90 days
intraoperative indicators
description of the patients' intraoperative condition relating to the safety of patients
Time frame: 90 days
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