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NCT Number: NCT03785743

Comparing Laparoscopic and Open Surgery for Pancreatic Carcinoma

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location status: Recruiting

Location contact

Junfang O Zhao, MD, PhD

CONTACT

[email protected]

+8615827539076

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TLPD Surgery

Procedure

TLPD

OPD Surgery

Procedure

OPD

Primary outcomes

  1. 5-year overall survival

    Time frame: 5 year

    5-year overall survival

Secondary outcomes

  1. overall survival

    Time frame: 5 years

    the interval between the day of surgery and the day of death for various reasons

  2. disease-free survival

    Time frame: 5 years

    the interval between the day of surgery and the day of tumour recurrence

  3. 90-day mortality

    Time frame: 90 days

    the percentage of patients who died within 90 days postoperatively

  4. complication rate

    Time frame: 90 days

    complications related to PD

  5. comprehensive complication index

    Time frame: 90 days

    calculated as the sum of all complications that are weighted for their severity

  6. length of stay

    Time frame: 90 days

    the number of nights spent in the hospital from the end of the surgical procedure until discharge or death

  7. intraoperative indicators

    Time frame: 90 days

    description of the patients' intraoperative condition relating to the safety of patients

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Dec 24, 2018
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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