Comparing Laparoscopic and Open Surgery for Pancreatic Carcinoma
Total Laparoscopic Pancreaticoduodenectomy Versus Open Pancreaticoduodenectomy for Pancreatic Carcinoma(TJDBPS07) a Multicenter Randomized Controlled Trial
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Renyi Qin
- Phone Number: +8602783665314
- Email: 172356995@qq.com
Study Contact Backup
- Name: Hag Zhang
- Phone Number: +8602783665314
- Email: 172356995@qq.com
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China, 430030
- Recruiting
- Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: TLPD
Total laparoscopic pancreaticoduodenectomy for pancreatic cancer
|
TLPD
|
|
EXPERIMENTAL: OPD
Open pancreaticoduodenectomy for pancreatic cancer
|
OPD
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
5-year overall survival
Time Frame: 5 year
|
5-year overall survival
|
5 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
overall survival
Time Frame: 5 years
|
the interval between the day of surgery and the day of death for various reasons
|
5 years
|
|
disease-free survival
Time Frame: 5 years
|
the interval between the day of surgery and the day of tumour recurrence
|
5 years
|
|
90-day mortality
Time Frame: 90 days
|
the percentage of patients who died within 90 days postoperatively
|
90 days
|
|
complication rate
Time Frame: 90 days
|
complications related to PD
|
90 days
|
|
comprehensive complication index
Time Frame: 90 days
|
calculated as the sum of all complications that are weighted for their severity
|
90 days
|
|
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
|
90 days
|
|
intraoperative indicators
Time Frame: 90 days
|
description of the patients' intraoperative condition relating to the safety of patients
|
90 days
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TJDBPS07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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