The Differences Of Complications Between LPD(Laparoscopic Pancreaticoduodenectomy) And OPD(Open Pancreaticoduodenectomy)

Study Overview

The Differences of Complications Between LPD(Laparoscopic Pancreaticoduodenectomy) and OPD(Open Pancreaticoduodenectomy)

Main objective: This project intends to design a simulated RCT project and clinically relevant RCT study to target, selecting the study titled "Short-Term outcomes Following Laparoscopic vs Open Pancreaticoduodenectomy in Patients With Pancreatic Ductal Adenocarcinoma: A Randomized Clinical Trial (Short-term Outcomes of Laparoscopic versus Open Pancreaticoduodenectomy in Patients with Pancreatic Ductal Adenocarcinoma)", use the cases in the Pancreatic Cancer Special Disease Cohort Database, compare the differences in complications and short-term prognosis between patients with pancreatic cancer after laparoscopic and open pancreaticoduodenectomy, investigate the efficacy and safety of laparoscopic pancreaticoduodenectomy, and provide the basis and reference of real-world data for clinical relevant studies. Secondary objective: To predict the incidence of postoperative complications and short-term outcomes of pancreatic cancer patients by comparing the difference of complications and short-term prognosis between laparoscopic and open pancreaticoduodenectomy, and to improve the treatment power of patients scheduled for surgery and postoperative patients.

N/A

Pancreatic Neoplasms

PROCEDURE: LPD

SHDC2024CRI080

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-11-10	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-11-11
First Submitted that Met QC Criteria 2024-11-11	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-11-13
First Posted (ACTUAL) 2024-11-13	Results First Posted N/A	Last Verified 2024-11

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: OPD The patients who received the OPD	PROCEDURE: LPD The patients who received the LPD

Participant Group/Arm

Intervention/Treatment

: OPD

The patients who received the OPD

PROCEDURE: LPD

The patients who received the LPD

Primary Outcome Measures	Measure Description	Time Frame
Overall survive		from the day after surgery to 3 years
complication	any possible symptoms caused by surgery	during the days Postoperative up to 1 year

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
19 Years

Accepts Healthy Volunteers:

Age: 18 years old, with no gender limit;
Histologically confirmed or clinically diagnosed as pancreatic cancer by MDT (multidisciplinary team), without histopathological evidence;
Patients may receive LPD or OPD according to the MDT evaluation;
Patients understand and are willing to comply with the trial;
Signed written informed consent before patient enrollment;
Patients who meet the clinical guidelines for intent to treat.
Those who met each of the above criteria were included in the study.

Patients with distant metastasis found before or during surgery, including peritoneal, liver, distant lymph node metastasis, and other organ involvement;
Patients who need pancreatic neck or pancreatic tail, total pancreatic resection or other palliative surgery;
Preoperative anesthesia ASA score of 4 points;
A history of other malignant tumors;
Pregnant or lactating women;
Patients with severe mental disorders;
MDT evaluates patients with vascular invasion and requiring vascular resection based on abdominal imaging data;
Patients who have participated in other clinical trials within 3 months. Those who meet any of the above criteria were not included in the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Ruijin Hospital

Investigators

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record