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/37878305Actively Recruiting
Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID03785743
Total Laparoscopic Pancreaticoduodenectomy Versus Open Pancreaticoduodenectomy for Pancreatic Carcinoma (TJDBPS07) A Multicenter Randomized Controlled Trial
Led by Tongji Hospital ยท Updated on 2022-03-02
200
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
T
Tongji Hospital
Lead Sponsor
S
Shandong Provincial Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Brief Title
Comparing Laparoscopic and Open Surgery for Pancreatic Carcinoma
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 18 years and 75 years
- Histologically confirmed pancreatic ductal adenocarcinoma (PDAC) or clinically diagnosed PDAC by a multidisciplinary team
- Suitable for both laparoscopic and open pancreaticoduodenectomy based on team evaluation
- Understanding and willing to comply with study requirements
- Written informed consent provided before registration
- Meeting curative treatment intent according to clinical guidelines
You will not qualify if you...
- Presence of distant metastases including peritoneal, liver, distant lymph nodes, or other organs
- Need for left, central, or total pancreatectomy or other palliative surgery
- Preoperative American Society of Anaesthesiologists (ASA) score 4 or higher
- History of other malignant diseases
- Pregnant or breastfeeding women
- Serious mental disorders
- Previous neoadjuvant therapy
- Vascular invasion requiring vascular resection as assessed by imaging and team
- Body mass index over 35 kg/m2
- Participation in another clinical trial within the last 3 months
AI-Screening
AI-Powered Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
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
Follow-up
Duration - Up to 5 years
Participants are monitored for survival and complications after surgery.
Regular follow-up visits as scheduled
Trial Site Locations
Total: 1 location
1
Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Actively Recruiting
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Research Team
R
Renyi Qin
H
Hag Zhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Laparoscopic versus open pancreaticoduodenectomy for pancreatic ductal adenocarcinoma: study protocol for a multicentre randomised controlled trial.
Shutao Pan, Tingting Qin, Taoyuan Yin...
https://pubmed.ncbi.nlm.nih.gov/35379633