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

• Conditions: Pancreatic Neoplasms

• Registration Number: NCT06685939
• Lead Sponsor: Zhijun Bao

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2022-12-31
• Status Verified: 2024-11
• Study First Submitted: 2024-11-10
• Study First Submitted QC: 2024-11-11
• Last Update Submitted: 2024-11-11
• Study First Posted: 2024-11-13
• Last Update Posted: 2024-11-13
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 220

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survive	from the day after surgery to 3 years
complication	during the days Postoperative up to 1 year	any possible symptoms caused by surgery

Trial Locations

Locations (1)

Huadong Hospital; 🇨🇳 Shanghai, China