Actively Recruiting
Comparing Laparoscopic and Open Surgery for Pancreatic Carcinoma
Led by Tongji Hospital · Updated on 2022-03-02
200
Participants Needed
1
Research Sites
426 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
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.
CONDITIONS
Official Title
Comparing Laparoscopic and Open Surgery for Pancreatic Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 years and 75 years
- Histologically confirmed pancreatic ductal adenocarcinoma (PDAC) or clinical diagnosis by a multidisciplinary team without histopathologic evidence
- Suitability to undergo both laparoscopic and open pancreaticoduodenectomy as evaluated by a multidisciplinary team
- Understanding of and willingness to comply with the trial
- Provision of written informed consent 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 node metastases, or other organ involvement
- Need for left, central, or total pancreatectomy or other palliative surgery
- Preoperative American Society of Anaesthesiologists (ASA) score of 4 or higher
- History of other malignant disease
- Pregnant or breastfeeding women
- Serious mental disorders
- Previous neoadjuvant therapy
- Vascular invasion requiring vascular resection based on imaging and multidisciplinary team evaluation
- Body mass index greater than 35 kg/m2
- Participation in any other clinical trials within 3 months prior
AI-Screening
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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
Research Team
R
Renyi Qin
CONTACT
H
Hag Zhang
CONTACT
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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