Comparing Laparoscopic and Open Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas

Not Applicable

• Conditions: Periampullary Adenocarcinoma
• Interventions: Procedure: open pancreaticoduodenectomy; Procedure: laparoscopic pancreaticoduodenectomy

• Registration Number: NCT05788029
• Lead Sponsor: Tongji Hospital

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2022-11-30
• Study First Submitted QC: 2023-03-15
• Study First Posted: 2023-03-28
• Study Start: 2024-01-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-09
• Primary Completion: 2025-12-31
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 210

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
open pancreaticoduodenectomy	open pancreaticoduodenectomy	open pancreaticoduodenectomy
laparoscopic pancreaticoduodenectomy	laparoscopic pancreaticoduodenectomy	laparoscopic pancreaticoduodenectomy

Primary Outcome Measures

Name	Time	Method
length of hospital stay	90 days	defined as the number of nights spent in the hospital from the end of the surgical procedure until discharge or death

Secondary Outcome Measures

Name	Time	Method
mortality	90 days	mortality
1 year OS	1 year	1 year OS
morbidity	90 days	morbidity

Trial Locations

Locations (1)

Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China