Comparing Laparoscopic and Open Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas

Study Overview
=================
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

Official Title
-----------------
Comparing Laparoscopic and Open Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas

Conditions
-----------------
Periampullary Adenocarcinoma

Intervention / Treatment
-----------------
* Procedure: laparoscopic pancreaticoduodenectomy
* Procedure: open pancreaticoduodenectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: laparoscopic pancreaticoduodenectomy<br>laparoscopic pancreaticoduodenectomy | Procedure: laparoscopic pancreaticoduodenectomy<br>* laparoscopic pancreaticoduodenectomy<br>|
| Active Comparator: open pancreaticoduodenectomy<br>open pancreaticoduodenectomy | Procedure: open pancreaticoduodenectomy<br>* open pancreaticoduodenectomy<br>|

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 | 
| mortality | mortality | 90 days | 
| morbidity | morbidity | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non-pancreatic periampullary adenocarcinoma, laparoscopic pancreaticoduodenectomy