Comparing Laparoscopic and Open Surgery for Pancreatic Carcinoma
Total Laparoscopic Pancreaticoduodenectomy Versus Open Pancreaticoduodenectomy for Pancreatic Carcinoma(TJDBPS07) a Multicenter Randomized Controlled Trial
1 other identifier
interventional
200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2018
CompletedFirst Posted
Study publicly available on registry
December 24, 2018
CompletedStudy Start
First participant enrolled
March 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
March 2, 2022
February 1, 2022
8 years
December 20, 2018
February 27, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
5-year overall survival
5-year overall survival
5 year
Secondary Outcomes (7)
overall survival
5 years
disease-free survival
5 years
90-day mortality
90 days
complication rate
90 days
comprehensive complication index
90 days
- +2 more secondary outcomes
Study Arms (2)
TLPD
EXPERIMENTALTotal laparoscopic pancreaticoduodenectomy for pancreatic cancer
OPD
EXPERIMENTALOpen pancreaticoduodenectomy for pancreatic cancer
Interventions
Eligibility Criteria
You may qualify if:
- Age between 18 years and 75 years.
- Histologically confirmed PDAC or clinically diagnosed PDAC by an MDT without histopathologic evidence.
- Patients feasible to undergo both LPD and OPD according to MDT evaluations.
- Patients understanding and willing to comply with this trial.
- Provision of written informed consent before patient registration.
- Patients meeting the curative treatment intent in accordance with clinical guidelines.
You may not qualify if:
- Patients with distant metastases, including peritoneal, liver, distant lymph node metastases, and involvement of other organs.
- Patients requiring left, central or total pancreatectomy or other palliative surgery.
- Preoperative American Society of Anaesthesiologists (ASA) score ≥ 4.
- History of other malignant disease.
- Pregnant or breast-feeding women.
- Patients with serious mental disorders.
- Patients treated with neoadjuvant therapy.
- Patients with vascular invasion and requiring vascular resection as evaluated by the MDT team according to abdominal imaging data.
- Body mass index \> 35 kg/m2.
- Patients participating in any other clinical trials within 3 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tongji Hospitallead
- Shandong Provincial Hospitalcollaborator
- The Second Hospital of Hebei Medical Universitycollaborator
- The Affiliated Hospital of Xuzhou Medical Universitycollaborator
- Xinqiao Hospital of Chongqingcollaborator
- Hunan Provincial People's Hospitalcollaborator
- The First Hospital of Jilin Universitycollaborator
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen Universitycollaborator
- The Third Affiliated Hospital of Soochow Universitycollaborator
- Guangdong Provincial Hospital of Traditional Chinese Medicinecollaborator
- Affiliated Hospital of North Sichuan Medical Collegecollaborator
- First Affiliated Hospital of Chongqing Medical Universitycollaborator
- Peking Union Medical College Hospitalcollaborator
- Henan Provincial People's Hospitalcollaborator
- Sir Run Run Shaw Hospitalcollaborator
- Fujian Medical University Union Hospitalcollaborator
- Fudan Universitycollaborator
Study Sites (1)
Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Related Publications (2)
Wang M, Pan S, Qin T, Xu X, Huang X, Liu J, Chen X, Zhao W, Li J, Liu C, Li D, Liu J, Liu Y, Zhou B, Zhu F, Ji S, Cheng H, Li Z, Li J, Tang Y, Peng X, Yu G, Chen W, Ma H, Xiong Y, Meng L, Lu P, Zhang Z, Yu X, Zhang H, Qin R. Short-Term Outcomes Following Laparoscopic vs Open Pancreaticoduodenectomy in Patients With Pancreatic Ductal Adenocarcinoma: A Randomized Clinical Trial. JAMA Surg. 2023 Dec 1;158(12):1245-1253. doi: 10.1001/jamasurg.2023.5210.
PMID: 37878305DERIVEDPan S, Qin T, Yin T, Yu X, Li J, Liu J, Zhao W, Chen X, Li D, Liu J, Li J, Liu Y, Zhu F, Wang M, Zhang H, Qin R; Minimally Invasive Treatment Group in the Pancreatic Disease Branch of China's International Exchange and Promotion Association for Medicine and Healthcare (MITG-P-CPAM). Laparoscopic versus open pancreaticoduodenectomy for pancreatic ductal adenocarcinoma: study protocol for a multicentre randomised controlled trial. BMJ Open. 2022 Apr 4;12(4):e057128. doi: 10.1136/bmjopen-2021-057128.
PMID: 35379633DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Renyi Qin
Tongji Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 20, 2018
First Posted
December 24, 2018
Study Start
March 1, 2019
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
March 2, 2022
Record last verified: 2022-02