Clinical trial NCT03785743: Comparing Laparoscopic and Open Surgery for Pancreatic Carcinoma
Official title: Total Laparoscopic Pancreaticoduodenectomy Versus Open Pancreaticoduodenectomy for Pancreatic Carcinoma(TJDBPS07) a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreatic Carcinoma
Laparoscopic
Pancreaticoduodenectomy
Keywords: Pancreatic Carcinoma
Laparoscopic
Pancreaticoduodenectomy
Survival
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: Shandong Provincial Hospital
name: The Second Hospital of Hebei Medical University
name: The Affiliated Hospital of Xuzhou Medical University
name: Xinqiao Hospital of Chongqing
name: Hunan Provincial People's Hospital
name: The First Hospital of Jilin University
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: The Third Affiliated Hospital of Soochow University
name: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Afﬁliated Hospital of North Sichuan Medical College
name: First Affiliated Hospital of Chongqing Medical University
name: Peking Union Medical College Hospital
name: Henan Provincial People's Hospital
name: Sir Run Run Shaw Hospital
name: Fujian Medical University Union Hospital
name: Fudan University
First posted: 2018-12-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Age between 18 years and 75 years.
2. Histologically confirmed PDAC or clinically diagnosed PDAC by an MDT without histopathologic evidence.
3. Patients feasible to undergo both LPD and OPD according to MDT evaluations.
4. Patients understanding and willing to comply with this trial.
5. Provision of written informed consent before patient registration.
6. Patients meeting the curative treatment intent in accordance with clinical guidelines.

Exclusion Criteria:

1. Patients with distant metastases, including peritoneal, liver, distant lymph node metastases, and involvement of other organs.
2. Patients requiring left, central or total pancreatectomy or other palliative surgery.
3. Preoperative American Society of Anaesthesiologists (ASA) score ≥ 4.
4. History of other malignant disease.
5. Pregnant or breast-feeding women.
6. Patients with serious mental disorders.
7. Patients treated with neoadjuvant therapy.
8. Patients with vascular invasion and requiring vascular resection as evaluated by the MDT team according to abdominal imaging data.
9. Body mass index \> 35 kg/m2.
10. Patients participating in any other clinical trials within 3 months.

Primary outcomes:
measure: 5-year overall survival
timeFrame: 5 year
Secondary outcomes:
measure: overall survival
timeFrame: 5 years
measure: disease-free survival
timeFrame: 5 years
measure: 90-day mortality
timeFrame: 90 days
measure: complication rate
timeFrame: 90 days
measure: comprehensive complication index
timeFrame: 90 days
measure: length of stay
timeFrame: 90 days
measure: intraoperative indicators
timeFrame: 90 days
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Renyi Qin
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pan 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.