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: Enrolling by invitation
• 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 (Estimated): 212
• Phase: Not Applicable

Contacts and Locations

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

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
1 year OS	1 year OS	1 year
Operative time	Total duration of the surgical procedure(minutes)	From enrollment to the end of operation
Estimated blood loss	Intraoperative estimated blood loss volume(ml).	From enrollment to the end of operation
Intraoperative transfusion volume	Volume of blood products transfused during the operation(ml)	From enrollment to the end of operation
perioperative complication rate	proportion of patients experiencing postoperative complications)	90 days
mortality rate and unplanned readmission rate	percentage of patients who die or require unplanned readmission within 90 days post-operation	90 days
Karnofsky Performance Status (KPS) score	Functional status assessment. Scores range from 0 to 100, with higher scores indicating better functional status. Unit of Measure: score (0-100)	Preoperatively, at discharge(at hospital discharge, assessed up to 30 days postoperatively), and at 6 months postoperatively
Eastern Cooperative Oncology Group (ECOG) performance status score	Functional status assessment. Scores range from 0 to 5, with lower scores indicating better functional status. Unit of Measure: score (0-5)	Preoperatively, at discharge(at hospital discharge, assessed up to 30 days postoperatively), and at 6 months postoperatively
Surgical costs	Direct costs of the surgical procedure itself, including operating room fees, anesthesia fees, surgical supplies, and intraoperative medications. Unit of Measure: CNY	perioperatively
Total hospitalization expenses	Total inpatient costs from admission to discharge, including surgical costs, medications, bed charges, laboratory tests, imaging, nursing care, and other hospital services. Unit of Measure: CNY	perioperatively

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Collaborators: Shanxi Province Cancer Hospital; Fudan University; Qilu Hospital of Shandong University; Tianjin Medical University Cancer Institute and Hospital; The First Affiliated Hospital of University of South China; The Affiliated Hospital of Xuzhou Medical University; The First Affiliated Hospital of Dalian Medical University; First Affiliated Hospital of Harbin Medical University; Chongqing General Hospital; The Third Affiliated Hospital of Soochow University; Army Medical University, China; Nanfang Hospital, Southern Medical University
• Investigators: Principal Investigator: Renyi Qin, Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 1, 2028

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): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: laparoscopic pancreaticoduodenectomy; non-pancreatic periampullary adenocarcinoma
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; 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: Individual participant data will not be shared due to ethical restrictions approved by the ethics committees of all participating centres. The participant consent form did not include provisions for data sharing beyond the primary research team. The study protocol and statistical analysis plan are available as supplementary materials.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No