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OpenTrials
Enrolling by Invitation

NCT Number: NCT06685939

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.

Enrolling by Invitation

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Huadong Hospital

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LPD

Procedure

The patients who received the LPD

Primary outcomes

  1. Overall survive

    Time frame: from the day after surgery to 3 years

  2. complication

    Time frame: during the days Postoperative up to 1 year

    any possible symptoms caused by surgery

Sponsors and collaborators

Lead sponsor

Zhijun Bao

Other

Collaborators

  • Ruijin Hospital

Registry information

Official study title

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

Acronym: TDCBLAP

Important dates

Study start
2020
Primary completion
2022
Study completion
2025
First posted
Nov 13, 2024
Registry last updated
Nov 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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