Total Laparoscopic Pancreaticoduodenectomy Versus Open Pancreaticoduodenectomy for Pancreatic Carcinoma(TJDBPS07) a Multicenter Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Contact Information
Primary
Renyi Qin
172356995@qq.com
+8602783665314
Backup
Hag Zhang
172356995@qq.com
+8602783665314
Time Frame
Start Date: 2019-03-01
Estimated Completion Date: 2027-05-01
Participants
Target number of participants: 200
Treatments
Experimental: TLPD
Total laparoscopic pancreaticoduodenectomy for pancreatic cancer
Experimental: OPD
Open pancreaticoduodenectomy for pancreatic cancer
Sponsors
Collaborators: Hunan Provincial People's Hospital, The Second Hospital of Hebei Medical University, The Affiliated Hospital of Xuzhou Medical University, Peking Union Medical College Hospital, Fudan University, Guangdong Provincial Hospital of Traditional Chinese Medicine, Sir Run Run Shaw Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, First Affiliated Hospital of Chongqing Medical University, Henan Provincial People's Hospital, The Third Affiliated Hospital of Soochow University, Fujian Medical University Union Hospital, Xinqiao Hospital of Chongqing, The First Hospital of Jilin University, Affiliated Hospital of North Sichuan Medical College, Shandong Provincial Hospital
Leads: Tongji Hospital

This content was sourced from clinicaltrials.gov