Comparing Laparoscopic and Open Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas

NCT05788029 | Enrolling By Invitation DMC

• 1 other identifier: TJDBPS14
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Periampullary Adenocarcinoma

Keywords

non-pancreatic periampullary adenocarcinoma; laparoscopic pancreaticoduodenectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 1 year OS

  1 year

• mortality

  90 days

• morbidity

  90 days

Study Arms (2)

laparoscopic pancreaticoduodenectomy

EXPERIMENTAL

laparoscopic pancreaticoduodenectomy

Procedure: laparoscopic pancreaticoduodenectomy

open pancreaticoduodenectomy

ACTIVE COMPARATOR

open pancreaticoduodenectomy

Procedure: open pancreaticoduodenectomy

Interventions

laparoscopic pancreaticoduodenectomy PROCEDURE

laparoscopic pancreaticoduodenectomy

laparoscopic pancreaticoduodenectomy

open pancreaticoduodenectomy PROCEDURE

open pancreaticoduodenectomy

open pancreaticoduodenectomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 years and 75 years.
• Histologically confirmed NPPC or clinically diagnosed NPPC by an MDT without histopathologic evidence.
• Patients feasible to undergo both LPD and OPD ac- cording 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 ac- cordance with clinical guidelines.

You may not qualify if:

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

Sponsors & Collaborators

• Tongji Hospital: lead
• Fudan University: collaborator
• The First Affiliated Hospital of Dalian Medical University: collaborator
• The Affiliated Hospital of Xuzhou Medical University: collaborator
• The Third Affiliated Hospital of Soochow University: collaborator
• Shanxi Province Cancer Hospital: collaborator
• Army Medical University, China: collaborator
• Qilu Hospital of Shandong University: collaborator
• Nanfang Hospital, Southern Medical University: collaborator
• The First Affiliated Hospital of University of South China: collaborator
• First Affiliated Hospital of Harbin Medical University: collaborator
• Chongqing General Hospital: collaborator
• Tianjin Medical University Cancer Institute and Hospital: collaborator

Study Sites (1)

Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Study Officials

• Renyi Qin

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: March 28, 2023
• Study Start: January 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)