Comparing Total Laparoscopic Versus Open Pancreaticoduodenectomy

Total Laparoscopic Pancreaticoduodenectomy Versus Open Pancreaticoduodenectomy(TJDBPS01) a Multicenter Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Surgery; Periampullary Cancer; Pancreatic Ductal Adenocarcinoma
• Intervention / Treatment: Procedure: Total laparoscopic pancreaticoduodenectomy; Procedure: Open pancreaticoduodenectomy

• Study Type: Interventional
• Enrollment (Anticipated): 656
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Recruiting
      • Tongji Hospital
      • Contact: Hang Zhang, M.D.; Phone Number: +8613407148260; Email: okashiiyo@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Histologically proven periampullary cancer, including pancreatic cancer, bile duct cancer, duodenal cancer, et al.
2. Highly presumed malignancy with difficulties to obtain histological evidence.
3. Preoperative staging work up performed by upper abdomen enhanced CT scan.
4. The subject understands the nature of this trial and willing to comply.
5. Ability to provide written informed consent.
6. Patients treated with curative intent in accordance to international guidelines

Exclusion Criteria:

1. Distant metastases: peritoneal carcinomatosis, liver metastases, distant lymph node metastases, involvement of other organs.
2. Subjects undergoing left, central or total pancreatectomy.
3. Patients with high operative risk as defined by the American Society of Anesthesiologists (ASA) score >4.
4. Synchronous malignancy in other organs.
5. Previous underwent pancreatic resections.
6. Palliative surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TLPD; Ttotal laparoscopic pancreaticoduodenectomy	Procedure: Total laparoscopic pancreaticoduodenectomy; Total laparoscopic pancreaticoduodenectomy
Experimental: OPD; Open pancreaticoduodenectomy	Procedure: Open pancreaticoduodenectomy; Open pancreaticoduodenectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay	Length of stay was defined as the postoperative time interval in days	Up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimated blood loss	The amount of blood loss during surgical procedure.	Up to 24 months
Operation time	Time between first incision and last skin closure.	Up to 24 months
Mortality	Mortality was defined as any death that occurred in the 30 days after surgery or during the hospital stay.	Up to 24 months
Complication rate	Clavien-Dindo	Up to 24 months
CCI	comprehensive complication index	Up to 24 months
2 year survival	Overall survival rate for 24 months after surgery	Up to 24 months

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Collaborators: Guangdong Provincial Hospital of Traditional Chinese Medicine; Peking Union Medical College Hospital; The Second Hospital of Hebei Medical University; Shandong Provincial Hospital; Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University; The First Hospital of Jilin University; Henan Provincial People's Hospital; Hunan Provincial People's Hospital; Fujian Medical University Union Hospital; Xinqiao Hospital of Chongqing; Sir Run Run Shaw Hospital; First Affiliated Hospital of Chongqing Medical University; The Affiliated Hospital of Xuzhou Medical University; Affiliated Hospital of North Sichuan Medical College; The Third Affiliated Hospital of Soochow University

Publications and helpful links

General Publications

• Wang M, Li D, Chen R, Huang X, Li J, Liu Y, Liu J, Cheng W, Chen X, Zhao W, Li J, Tan Z, Huang H, Li D, Zhu F, Qin T, Ma J, Yu G, Zhou B, Zheng S, Tang Y, Han W, Meng L, Ke J, Feng F, Chen B, Yin X, Chen W, Ma H, Xu J, Liu Y, Lin R, Dong Y, Yu Y, Liu J, 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 pancreatoduodenectomy for pancreatic or periampullary tumours: a multicentre, open-label, randomised controlled trial. Lancet Gastroenterol Hepatol. 2021 Jun;6(6):438-447. doi: 10.1016/S2468-1253(21)00054-6. Epub 2021 Apr 27.
• Zhang H, Feng Y, Zhao J, Chen R, Chen X, Yin X, Cheng W, Li D, Li J, Huang X, Li J, Liu J, Liu J, Liu Y, Tan Z, Zhao W, Huang H, Li D, Yu Y, Wang M, Qin R. Total laparoscopic pancreaticoduodenectomy versus open pancreaticoduodenectomy (TJDBPS01): study protocol for a multicentre, randomised controlled clinical trial. BMJ Open. 2020 Feb 10;10(2):e033490. doi: 10.1136/bmjopen-2019-033490.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: February 7, 2017
• First Submitted That Met QC Criteria: April 28, 2017
• First Posted (Actual): May 3, 2017

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 5, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: pancreaticoduodenectomy; surgical outcome
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: TJDBPS01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No