Clinical trial NCT05788029: Comparing Laparoscopic and Open Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas
Official title: Comparing Laparoscopic and Open Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Periampullary Adenocarcinoma
Keywords: non-pancreatic periampullary adenocarcinoma
laparoscopic pancreaticoduodenectomy
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: Fudan University
name: The First Affiliated Hospital of Dalian Medical University
name: The Affiliated Hospital of Xuzhou Medical University
name: The Third Affiliated Hospital of Soochow University
name: Shanxi Province Cancer Hospital
name: Army Medical University, China
name: Qilu Hospital of Shandong University
name: Nanfang Hospital, Southern Medical University
name: The First Affiliated Hospital of University of South China
name: First Affiliated Hospital of Harbin Medical University
name: Chongqing General Hospital
name: Tianjin Medical University Cancer Institute and Hospital
First posted: 2023-03-28
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: length of hospital stay
timeFrame: 90 days
Secondary outcomes:
measure: 1 year OS
timeFrame: 1 year
measure: mortality
timeFrame: 90 days
measure: morbidity
timeFrame: 90 days
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Renyi Qin
role: PRINCIPAL_INVESTIGATOR
References: