Short-Term Outcomes Following Laparoscopic vs Open Pancreaticoduodenectomy in Patients With Pancreatic Ductal Adenocarcinoma: A Randomized Clinical Trial.
Min Wang, Shutao Pan, Tingting Qin...
https://pubmed.ncbi.nlm.nih.gov/37878305/Actively Recruiting
Led by Tongji Hospital · Updated on 2022-03-02
200
Participants Needed
1
Research Sites
8 weeks
Total Duration
Pancreatic cancer is a highly aggressive cancer with poor outcomes, and pancreatoduodenectomy PD is the only curative treatment option. This trial compares two surgical techniques total laparoscopic pancreaticoduodenectomy TLPD and open pancreaticoduodenectomy OPD in patients with pancreatic cancer. The study aims to explore overall survival, disease-free survival, and quality of life. This multicenter randomized controlled trial addresses the current debate over which surgical technique may offer better recovery and outcomes, with research spanning about seven years including follow-up and analysis. Participants will be randomly assigned to receive either TLPD or OPD, both performed with an enhanced recovery after surgery ERAS program. The trial includes 200 patients suitable for either surgical method according to a multidisciplinary team assessment. The study compares these two approaches to determine differences in recovery, complications, and survival outcomes. During the study, participants will be followed for up to five years to assess overall survival and disease-free survival, along with monitoring complications, mortality within 90 days, length of hospital stay, and surgical indicators. Researchers will collect data on recovery and quality of life, monitoring patients closely after surgery. The total trial duration is seven years, allowing comprehensive long-term follow-up and analysis of the surgical methods.
CONDITIONS
Comparing Laparoscopic and Open Surgery for Pancreatic Carcinoma
R
Renyi Qin
H
Hag Zhang
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Tongji Hospital
Lead Sponsor
Shandong Provincial Hospital
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 90 days
Participants undergo either total laparoscopic pancreaticoduodenectomy or open pancreaticoduodenectomy for pancreatic cancer, followed by immediate post-operative care.
Approximately 6 post-operative visits
Duration - Up to 5 years
Participants are monitored for survival and complications after surgery.
Regular follow-up visits as scheduled
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Min Wang, Shutao Pan, Tingting Qin...
https://pubmed.ncbi.nlm.nih.gov/37878305/Shutao Pan, Tingting Qin, Taoyuan Yin...
https://pubmed.ncbi.nlm.nih.gov/35379633/Tongji Hospital
Lead Sponsor
Shandong Provincial Hospital
Collaborating Sponsor