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

November 11, 2024 updated by: Zhijun Bao

To Investigate The Difference of Complications and Short-term Prognosis Between Laparoscopic and Open Pancreaticoduodenectomy in Patients With Pancreatic Cancer Based on a Special Disease Cohort Database

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

220

Contacts and Locations

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

Study Locations

  • China
      • Shanghai, China
        • Huadong Hospital

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All patients treated with LPD or OPD for pancreatic cancer in Huadong Hospital from 1,January 2020 to 31,December 2022

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
OPD
The patients who received the OPD
Procedure: LPD
The patients who received the LPD

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Zhijun Bao

Collaborators

Ruijin Hospital, The Shanghai Jiao Tong University Medical School

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 Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

December 31, 2022

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

November 10, 2024

First Submitted That Met QC Criteria

November 11, 2024

First Posted (Estimated)

November 13, 2024

Study Record Updates

Last Update Posted (Estimated)

November 13, 2024

Last Update Submitted That Met QC Criteria

November 11, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHDC2024CRI080

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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