Comparing Laparoscopic and Open Surgery for Pancreatic Carcinoma

Pancreatic Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03785743
• Other study ID #: TJDBPS07
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: May 1, 2027

Study information

• Verified date: February 2022
• Source: Tongji Hospital
• Contact: Renyi Qin
• Phone: +8602783665314
• Email: 172356995[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 1, 2027
• Est. primary completion date: March 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Laparoscopic
• Pancreatic Carcinoma
• Pancreatic Neoplasms
• Pancreaticoduodenectomy

Intervention

Procedure:
• TLPD Surgery
TLPD
• OPD Surgery
OPD

Locations

Country	Name	City	State
China	Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (17)

Lead Sponsor

Collaborator

Tongji Hospital

Af?liated 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

Country where clinical trial is conducted

China, 

Outcome

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