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Recruiting NCT03785743

Comparing Laparoscopic and Open Surgery for Pancreatic Carcinoma

No phase Interventional Pancreatic Carcinoma Laparoscopic Pancreaticoduodenectomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TLPD Surgery, OPD Surgery.
Who it may be relevant to
Registry conditions: Pancreatic Carcinoma, Laparoscopic, Pancreaticoduodenectomy. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Procedure TLPD Surgery
    TLPD
  • Procedure OPD Surgery
    OPD

Primary outcome measures

  • 5-year overall survival [Time frame: 5 year]
Secondary outcome measures (7)
  • overall survival [Time frame: 5 years]
  • disease-free survival [Time frame: 5 years]
  • 90-day mortality [Time frame: 90 days]
  • complication rate [Time frame: 90 days]
  • comprehensive complication index [Time frame: 90 days]
  • length of stay [Time frame: 90 days]
  • intraoperative indicators [Time frame: 90 days]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • Patients with distant metastases, including peritoneal, liver, distant lymph node metastases, and involvement of other organs.
  • Patients requiring left, central or total pancreatectomy or other palliative surgery.
  • Preoperative American Society of Anaesthesiologists (ASA) score ≥ 4.
  • History of other malignant disease.
  • Pregnant or breast-feeding women.
  • Patients with serious mental disorders.
  • Patients treated with neoadjuvant therapy.
  • Patients with vascular invasion and requiring vascular resection as evaluated by the MDT team according to abdominal imaging data.
  • Body mass index > 35 kg/m2.
  • Patients participating in any other clinical trials within 3 months.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical C — Wuhan

Publications

  • Wang M, Pan S, Qin T, Xu X, Huang X, Liu J, Chen X, Zhao W, Li J, Liu C, Li D, Liu J, Liu Y, Zhou B, Zhu F, Ji S, Cheng H, Li Z, Li J, Tang Y, Peng X, Yu G, Chen W, Ma H, Xiong Y, Meng L, Lu P, Zhang Z, Yu X, Zhang H, Qin R. Short-Term Outcomes Following Laparoscopic vs Open Pancreaticoduodenectomy in Patients With Pancreatic Ductal Adenocarcinoma: A Randomized Clinical Trial. JAMA Surg. 2023 Dec PMID 37878305
  • Pan S, Qin T, Yin T, Yu X, Li J, Liu J, Zhao W, Chen X, Li D, Liu J, Li J, Liu Y, Zhu F, Wang M, 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 pancreaticoduodenectomy for pancreatic ductal adenocarcinoma: study protocol for a multicen PMID 35379633

Identifiers

NCT: NCT03785743 · TJDBPS07

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗