Comparing Total Laparoscopic Versus Open Pancreaticoduodenectomy

Summary

Introduction Pancreatoduodenectomy (PD) is one of the most complex abdominal operations to perform, and it is usually conducted for tumours of the periampullary region and chronic pancreatitis. Minimally invasive surgery has been progressively being developed for pancreatic surgery, first with the advent of hybrid-laparoscopy and recently with total laparoscopic surgery. Issues including the safety and efficacy of total laparoscopic pancreaticoduodenectomy (TLPD) and open pancreaticoduodenectomy (OPD) are currently being debated. Studies comparing these two surgical techniques are emerging, and large randomized controlled trials (RCTs) are lacking but are clearly required.

Methods and analysis TJDBPS01 is a multicentre, prospective, randomized controlled, parallel-group, superiority trial in fourteen centres with pancreatic surgery experts who have performed ≥104 TLPDs and OPDs. A total of 656 patients who will undergo PD are randomly allocated to the TLPD group or OPD group in a 1:1 ratio. The trial hypothesis is that TLPD has superior or equivalent safety and advantages in postoperative recovery compared with OPD. The primary outcome is the postoperative length of stay (LOS).

Ethics and dissemination The Instituitional Review Board Approval of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology has approved this trial and will be routinely monitoring the trial at frequent intervals, as will an independent third-party organization. Any results from this trial (publications, conference presentations) will be published in peer-reviewed journals and conference proceedings.

Conditions

• Pancreatic Ductal Adenocarcinoma
• Surgery
• Periampullary Cancer

Interventions

PROCEDURE

Total laparoscopic pancreaticoduodenectomy

Total laparoscopic pancreaticoduodenectomy

PROCEDURE

Open pancreaticoduodenectomy

Open pancreaticoduodenectomy

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

• Tongji Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-05-01

Primary Completion

2022-05-01

Completion

2022-05-01

Countries

• China

Study Locations