Comparing Laparoscopic and Open Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas

Periampullary Adenocarcinoma Clinical Trial

— NPPC  

Official title:

Comparing Laparoscopic and Open Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05788029
• Other study ID #: TJDBPS14
• Secondary ID: TJDBPS14
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2023
• Est. completion date: December 2025

Study information

• Verified date: March 2023
• Source: Tongji Hospital
• Contact: Hang Zhang
• Phone: +8602783665314
• Email: zhanghang[@]hust.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Periampullary Adenocarcinoma

Intervention

Procedure:
• laparoscopic pancreaticoduodenectomy
laparoscopic pancreaticoduodenectomy
• open pancreaticoduodenectomy
open pancreaticoduodenectomy

Locations

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

Sponsors (11)

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

Country where clinical trial is conducted

China, 

Outcome

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