An interventional study of TLPD Surgery and OPD Surgery in Pancreatic Carcinoma, Laparoscopic and Pancreaticoduodenectomy, sponsored by Tongji Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-03-02.
Sponsored by Tongji Hospital · Not applicable, Interventional, and Treatment
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 200 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Tongji Hospital is the lead sponsor of 373 studies on the registry; 204 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Total laparoscopic pancreaticoduodenectomy for pancreatic cancer
Procedure: TLPD Surgery
Open pancreaticoduodenectomy for pancreatic cancer
Procedure: OPD Surgery
TLPD
OPD
5-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
Plan to share: Undecided
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Tongji Hospital