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Comparing Laparoscopic and Open Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas (NPPC)

Primary Purpose

Periampullary Adenocarcinoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
laparoscopic pancreaticoduodenectomy
open pancreaticoduodenectomy
Sponsored by
Tongji Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periampullary Adenocarcinoma focused on measuring non-pancreatic periampullary adenocarcinoma, laparoscopic pancreaticoduodenectomy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age between 18 years and 75 years. Histologically confirmed NPPC or clinically diagnosed NPPC by an MDT without histopathologic evidence. Patients feasible to undergo both LPD and OPD ac- cording to MDT evaluations. Patients understanding and willing to comply with this trial. Provision of written informed consent before patient registration. Patients meeting the curative treatment intent in ac- cordance with clinical guidelines. Exclusion Criteria: Patients with distant metastases, including peritone- al, liver, distant lymph node metastases and involve- ment of other organs. Patients requiring left, central or total pancreatecto- my or other palliative surgery. Preoperative American Society of Anaesthesiologists (ASA) score ≥4. History of other malignant disease Pregnant or breastfeeding women. Patients with serious mental disorders Patients treated with neoadjuvant therapy. Patients with vascular invasion and requiring vascular resection as evaluated by the MDT team according to abdominal imaging data. Body mass index >35 kg/m 2 . Patients participating in any other clinical trials with- in 3 months.

Sites / Locations

  • Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

laparoscopic pancreaticoduodenectomy

open pancreaticoduodenectomy

Arm Description

laparoscopic pancreaticoduodenectomy

open pancreaticoduodenectomy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

1 year OS
1 year OS
mortality
mortality
morbidity
morbidity

Full Information

First Posted
November 30, 2022
Last Updated
March 15, 2023
Sponsor
Tongji Hospital
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT05788029
Brief Title
Comparing Laparoscopic and Open Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas
Acronym
NPPC
Official Title
Comparing Laparoscopic and Open Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji Hospital
Collaborators
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periampullary Adenocarcinoma
Keywords
non-pancreatic periampullary adenocarcinoma, laparoscopic pancreaticoduodenectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
laparoscopic pancreaticoduodenectomy
Arm Type
Experimental
Arm Description
laparoscopic pancreaticoduodenectomy
Arm Title
open pancreaticoduodenectomy
Arm Type
Active Comparator
Arm Description
open pancreaticoduodenectomy
Intervention Type
Procedure
Intervention Name(s)
laparoscopic pancreaticoduodenectomy
Intervention Description
laparoscopic pancreaticoduodenectomy
Intervention Type
Procedure
Intervention Name(s)
open pancreaticoduodenectomy
Intervention Description
open pancreaticoduodenectomy
Primary Outcome Measure Information:
Title
length of hospital stay
Description
defined as the number of nights spent in the hospital from the end of the surgical procedure until discharge or death
Time Frame
90 days
Secondary Outcome Measure Information:
Title
1 year OS
Description
1 year OS
Time Frame
1 year
Title
mortality
Description
mortality
Time Frame
90 days
Title
morbidity
Description
morbidity
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18 years and 75 years. Histologically confirmed NPPC or clinically diagnosed NPPC by an MDT without histopathologic evidence. Patients feasible to undergo both LPD and OPD ac- cording to MDT evaluations. Patients understanding and willing to comply with this trial. Provision of written informed consent before patient registration. Patients meeting the curative treatment intent in ac- cordance with clinical guidelines. Exclusion Criteria: Patients with distant metastases, including peritone- al, liver, distant lymph node metastases and involve- ment of other organs. Patients requiring left, central or total pancreatecto- my or other palliative surgery. Preoperative American Society of Anaesthesiologists (ASA) score ≥4. History of other malignant disease Pregnant or breastfeeding women. Patients with serious mental disorders Patients treated with neoadjuvant therapy. Patients with vascular invasion and requiring vascular resection as evaluated by the MDT team according to abdominal imaging data. Body mass index >35 kg/m 2 . Patients participating in any other clinical trials with- in 3 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hang Zhang
Phone
+8602783665314
Email
zhanghang@hust.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renyi Qin
Organizational Affiliation
Tongji Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Share only when contact to Principal Investigator

Learn more about this trial

Comparing Laparoscopic and Open Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas

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