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Trial Title:
Comparing Laparoscopic and Open Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas
NCT ID:
NCT05788029
Condition:
Periampullary Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Conditions: Keywords:
non-pancreatic periampullary adenocarcinoma
laparoscopic pancreaticoduodenectomy
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Procedure
Intervention name:
laparoscopic pancreaticoduodenectomy
Description:
laparoscopic pancreaticoduodenectomy
Arm group label:
laparoscopic pancreaticoduodenectomy
Intervention type:
Procedure
Intervention name:
open pancreaticoduodenectomy
Description:
open pancreaticoduodenectomy
Arm group label:
open pancreaticoduodenectomy
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
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430030
Country:
China
Start date:
December 2023
Completion date:
December 2025
Lead sponsor:
Agency:
Tongji Hospital
Agency class:
Other
Collaborator:
Agency:
Fudan University
Agency class:
Other
Collaborator:
Agency:
Shanxi Province Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
The Second Affiliated Hospital of Chongqing Medical University
Agency class:
Other
Collaborator:
Agency:
The First Hospital of Jilin University
Agency class:
Other
Collaborator:
Agency:
The Second Hospital of Hebei Medical University
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Dalian Medical University
Agency class:
Other
Collaborator:
Agency:
The Third Affiliated Hospital of Soochow University
Agency class:
Other
Collaborator:
Agency:
The Affiliated Hospital of Xuzhou Medical University
Agency class:
Other
Collaborator:
Agency:
Chongqing University Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Hunan Provincial People's Hospital
Agency class:
Other
Source:
Tongji Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05788029
