NCT03138213

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
656

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 3, 2017

Completed
12 months until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

4 years

First QC Date

February 7, 2017

Last Update Submit

October 5, 2020

Conditions

Pancreatic Ductal AdenocarcinomaSurgeryPeriampullary Cancer

Keywords

pancreaticoduodenectomysurgical outcome

Outcome Measures

Primary Outcomes (1)

  • Length of stay

    Length of stay was defined as the postoperative time interval in days

    Up to 24 months

Secondary Outcomes (6)

  • Estimated blood loss

    Up to 24 months

  • Operation time

    Up to 24 months

  • Mortality

    Up to 24 months

  • Complication rate

    Up to 24 months

  • CCI

    Up to 24 months

  • +1 more secondary outcomes

Study Arms (2)

TLPD

EXPERIMENTAL

Ttotal laparoscopic pancreaticoduodenectomy

Procedure: Total laparoscopic pancreaticoduodenectomy

OPD

EXPERIMENTAL

Open pancreaticoduodenectomy

Procedure: Open pancreaticoduodenectomy

Interventions

Total laparoscopic pancreaticoduodenectomyPROCEDURE

Total laparoscopic pancreaticoduodenectomy

TLPD
Open pancreaticoduodenectomyPROCEDURE

Open pancreaticoduodenectomy

OPD

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430000, China

RECRUITING

Related Publications (3)

  • Qin T, Zhang H, Pan S, Liu J, Li D, Chen R, Huang X, Liu Y, Liu J, Cheng W, Chen X, Zhao W, Li J, Tan Z, Huang H, Li D, Zhu F, Yu G, Zhou B, Zheng S, Tang Y, Ke J, Liu X, Chen B, Chen W, Ma H, Xu J, Liu Y, Lin R, Dong Y, Yu Y, Wang M, 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). Effect of Laparoscopic and Open Pancreaticoduodenectomy for Pancreatic or Periampullary Tumors: Three-year Follow-up of a Randomized Clinical Trial. Ann Surg. 2024 Apr 1;279(4):605-612. doi: 10.1097/SLA.0000000000006149. Epub 2023 Nov 15.

    PMID: 37965767DERIVED

  • 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.

    PMID: 33915091DERIVED

  • 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.

    PMID: 32047015DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

February 7, 2017

First Posted

May 3, 2017

Study Start

May 1, 2018

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

October 8, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)