Periampullary Adenocarcinoma Clinical Trial
— NPPCOfficial title:
Comparing Laparoscopic and Open Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas
Verified date | March 2023 |
Source | Tongji Hospital |
Contact | Hang Zhang |
Phone | +8602783665314 |
zhanghang[@]hust.edu.cn | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study was to evaluate the outcomes of LPD versus OPD in non-pancreatic periampullary adenocarcinoma
Status | Not yet recruiting |
Enrollment | 210 |
Est. completion date | December 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Tongji Hospital | Chongqing University Cancer Hospital, Fudan University, Hunan Provincial People's Hospital, Shanxi Province Cancer Hospital, The Affiliated Hospital of Xuzhou Medical University, The First Affiliated Hospital of Dalian Medical University, The First Hospital of Jilin University, The Second Affiliated Hospital of Chongqing Medical University, The Second Hospital of Hebei Medical University, The Third Affiliated Hospital of Soochow University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 1 year OS | 1 year OS | 1 year | |
Secondary | mortality | mortality | 90 days | |
Secondary | morbidity | morbidity | 90 days |
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