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: Recruiting
• Conditions: Pancreatic Carcinoma; Pancreaticoduodenectomy; Laparoscopic
• Intervention / Treatment: Procedure: TLPD Surgery; Procedure: OPD Surgery

• Study Type: Interventional
• Enrollment (Anticipated): 200
• 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

• China
  • 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: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: TLPD; Total laparoscopic pancreaticoduodenectomy for pancreatic cancer	Procedure: TLPD Surgery; TLPD
EXPERIMENTAL: OPD; Open pancreaticoduodenectomy for pancreatic cancer	Procedure: OPD Surgery; OPD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
5-year overall survival	5-year overall survival	5 year

Secondary Outcome Measures

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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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 multicentre randomised controlled trial. BMJ Open. 2022 Apr 4;12(4):e057128. doi: 10.1136/bmjopen-2021-057128.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2019
• Primary Completion (ANTICIPATED): March 1, 2027
• Study Completion (ANTICIPATED): May 1, 2027

Study Registration Dates

• First Submitted: December 20, 2018
• First Submitted That Met QC Criteria: December 20, 2018
• First Posted (ACTUAL): December 24, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 27, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Survival; Laparoscopic; Pancreaticoduodenectomy; Pancreatic Carcinoma
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Carcinoma; Pancreatic Neoplasms
• Other Study ID Numbers: TJDBPS07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No