Comparing Laparoscopic and Open Surgery for Pancreatic Carcinoma

Not Applicable

Recruiting

• Conditions: Pancreaticoduodenectomy; Laparoscopic; Pancreatic Carcinoma
• Interventions: Procedure: TLPD Surgery; Procedure: OPD Surgery

• Registration Number: NCT03785743
• Lead Sponsor: Tongji Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-20
• Study First Submitted QC: 2018-12-20
• Study First Posted: 2018-12-24
• Study Start: 2019-03-01
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-27
• Last Update Posted: 2022-03-02
• Primary Completion: 2027-03-01
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Age between 18 years and 75 years.
2. Histologically confirmed PDAC or clinically diagnosed PDAC by an MDT without histopathologic evidence.
3. Patients feasible to undergo both LPD and OPD according to MDT evaluations.
4. Patients understanding and willing to comply with this trial.
5. Provision of written informed consent before patient registration.
6. Patients meeting the curative treatment intent in accordance with clinical guidelines.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TLPD	TLPD Surgery	Total laparoscopic pancreaticoduodenectomy for pancreatic cancer
OPD	OPD Surgery	Open pancreaticoduodenectomy for pancreatic cancer

Primary Outcome Measures

Name	Time	Method
5-year overall survival	5 year	5-year overall survival

Secondary Outcome Measures

Name	Time	Method
overall survival	5 years	the interval between the day of surgery and the day of death for various reasons
disease-free survival	5 years	the interval between the day of surgery and the day of tumour recurrence
90-day mortality	90 days	the percentage of patients who died within 90 days postoperatively
complication rate	90 days	complications related to PD
comprehensive complication index	90 days	calculated as the sum of all complications that are weighted for their severity
length of stay	90 days	the number of nights spent in the hospital from the end of the surgical procedure until discharge or death
intraoperative indicators	90 days	description of the patients' intraoperative condition relating to the safety of patients

Trial Locations

Locations (1)

Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China