Comparing Laparoscopic and Open Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas (NPPC)

The aim of this study was to evaluate the outcomes of LPD versus OPD in non-pancreatic periampullary adenocarcinoma

Study Overview

• Status: Not yet recruiting
• Conditions: Periampullary Adenocarcinoma
• Intervention / Treatment: Procedure: laparoscopic pancreaticoduodenectomy; Procedure: open pancreaticoduodenectomy

Detailed Description

The aim of this study was to evaluate the outcomes of LPD versus OPD in non-pancreatic periampullary adenocarcinoma

• Study Type: Interventional
• Enrollment (Anticipated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hang Zhang; Phone Number: +8602783665314; Email: zhanghang@hust.edu.cn

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • 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 NPPC or clinically diagnosed NPPC by an MDT without histopathologic evidence.
3. Patients feasible to undergo both LPD and OPD ac- cording 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 ac- cordance with clinical guidelines.

Exclusion Criteria:

1. Patients with distant metastases, including peritone- al, liver, distant lymph node metastases and involve- ment of other organs.
2. Patients requiring left, central or total pancreatecto- my or other palliative surgery.
3. Preoperative American Society of Anaesthesiologists (ASA) score ≥4.
4. History of other malignant disease
5. Pregnant or breastfeeding 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/m 2 .
10. Patients participating in any other clinical trials with- in 3 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: laparoscopic pancreaticoduodenectomy	Procedure: laparoscopic pancreaticoduodenectomy; laparoscopic pancreaticoduodenectomy
Active Comparator: open pancreaticoduodenectomy	Procedure: open pancreaticoduodenectomy; open pancreaticoduodenectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of hospital stay	defined as the number of nights spent in the hospital from the end of the surgical procedure until discharge or death	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality	mortality	90 days
1 year OS	1 year OS	1 year
morbidity	morbidity	90 days

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Collaborators: Shanxi Province Cancer Hospital; Chongqing University Cancer Hospital; Fudan University; The Second Hospital of Hebei Medical University; The First Hospital of Jilin University; Hunan Provincial People's Hospital; The Second Affiliated Hospital of Chongqing Medical University; The Affiliated Hospital of Xuzhou Medical University; The First Affiliated Hospital of Dalian Medical University; The Third Affiliated Hospital of Soochow University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2023
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: November 30, 2022
• First Submitted That Met QC Criteria: March 15, 2023
• First Posted (Actual): March 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 15, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: laparoscopic pancreaticoduodenectomy; non-pancreatic periampullary adenocarcinoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: TJDBPS14 (Other Identifier: Tongji Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Share only when contact to Principal Investigator

Drug and device information, study documents

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