NPPC: Comparing Laparoscopic and Open Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas

• Sponsor: Tongji Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05788029
• Collaborator: Fudan University (Other), Shanxi Province Cancer Hospital (Other), The Second Affiliated Hospital of Chongqing Medical University (Other), The First Hospital of Jilin University (Other), The Second Hospital of Hebei Medical University (Other), The First Affiliated Hospital of Dalian Medical University (Other), The Third Affiliated Hospital of Soochow University (Other), The Affiliated Hospital of Xuzhou Medical University (Other), Chongqing University Cancer Hospital (Other), Hunan Provincial People's Hospital (Other)
• Enrollment: 210
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 8.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Periampullary Adenocarcinoma	Procedure: laparoscopic pancreaticoduodenectomy; Procedure: open pancreaticoduodenectomy	N/A

Detailed Description

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 210 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparing Laparoscopic and Open Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas
• Anticipated Study Start Date: Dec 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: laparoscopic pancreaticoduodenectomy laparoscopic pancreaticoduodenectomy	Procedure: laparoscopic pancreaticoduodenectomy; laparoscopic pancreaticoduodenectomy
Active Comparator: open pancreaticoduodenectomy open pancreaticoduodenectomy	Procedure: open pancreaticoduodenectomy; open pancreaticoduodenectomy

Outcome Measures

Primary Outcome Measures

1. length of hospital stay [90 days]

   defined as the number of nights spent in the hospital from the end of the surgical procedure until discharge or death

Secondary Outcome Measures

1. 1 year OS [1 year]

   1 year OS

2. mortality [90 days]

   mortality

3. morbidity [90 days]

   morbidity

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei	China	430030

Sponsors and Collaborators

• Tongji Hospital
• Fudan University
• Shanxi Province Cancer Hospital
• The Second Affiliated Hospital of Chongqing Medical University
• The First Hospital of Jilin University
• The Second Hospital of Hebei Medical University
• The First Affiliated Hospital of Dalian Medical University
• The Third Affiliated Hospital of Soochow University
• The Affiliated Hospital of Xuzhou Medical University
• Chongqing University Cancer Hospital
• Hunan Provincial People's Hospital

Investigators

• Principal Investigator: Renyi Qin, Tongji Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Renyi Qin, Prof, Tongji Hospital
• ClinicalTrials.gov Identifier: NCT05788029
• Other Study ID Numbers: TJDBPS14; TJDBPS14
• First Posted: Mar 28, 2023
• Last Update Posted: Mar 28, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Renyi Qin, Prof, Tongji Hospital: non-pancreatic periampullary adenocarcinoma; laparoscopic pancreaticoduodenectomy
• Additional relevant MeSH terms: Adenocarcinoma

Study Results

No Results Posted as of Mar 28, 2023