Comparing Laparoscopic and Open Surgery for Pancreatic Carcinoma

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.

Conditions

• Pancreatic Carcinoma
• Laparoscopic
• Pancreaticoduodenectomy

Interventions

PROCEDURE

TLPD Surgery

TLPD

PROCEDURE

OPD Surgery

OPD

Sponsors & Collaborators

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• The Second Hospital of Hebei Medical University

  collaborator OTHER

• The Affiliated Hospital of Xuzhou Medical University

  collaborator OTHER

• Xinqiao Hospital of Chongqing

  collaborator OTHER

• Hunan Provincial People's Hospital

  collaborator OTHER

• The First Hospital of Jilin University

  collaborator OTHER

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  collaborator OTHER

• The Third Affiliated Hospital of Soochow University

  collaborator OTHER

• Guangdong Provincial Hospital of Traditional Chinese Medicine

  collaborator OTHER

• Affiliated Hospital of North Sichuan Medical College

  collaborator OTHER

• First Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• Peking Union Medical College Hospital

  collaborator OTHER

• Henan Provincial People's Hospital

  collaborator OTHER

• Sir Run Run Shaw Hospital

  collaborator OTHER

• Fujian Medical University Union Hospital

  collaborator OTHER

• Fudan University

  collaborator OTHER

• Tongji Hospital

  lead OTHER

Principal Investigators

• Renyi Qin · Tongji Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-01

Primary Completion

2027-03-01

Completion

2027-05-01

Countries

• China

Study Locations