Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Location status: Recruiting
NCT Number: NCT03785743
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Wuhan, Hubei, 430030, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
TLPD
OPD
Time frame: 5 year
5-year overall survival
Time frame: 5 years
the interval between the day of surgery and the day of death for various reasons
Time frame: 5 years
the interval between the day of surgery and the day of tumour recurrence
Time frame: 90 days
the percentage of patients who died within 90 days postoperatively
Time frame: 90 days
complications related to PD
Time frame: 90 days
calculated as the sum of all complications that are weighted for their severity
Time frame: 90 days
the number of nights spent in the hospital from the end of the surgical procedure until discharge or death
Time frame: 90 days
description of the patients' intraoperative condition relating to the safety of patients
Contact information is provided by the study sponsor or research team.
Hag Zhang
CONTACT
Renyi Qin
CONTACT
Tongji Hospital
Other
Total Laparoscopic Pancreaticoduodenectomy Versus Open Pancreaticoduodenectomy for Pancreatic Carcinoma(TJDBPS07) a Multicenter Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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