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

NCT ID: NCT06685939

Last Updated: 2024-11-13

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 220 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2025-07-31

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.

Conditions

Pancreatic Neoplasms

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

OPD

The patients who received the OPD

LPD

Intervention Type: PROCEDURE

The patients who received the LPD

Interventions

LPD

The patients who received the LPD

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: collaborator

Zhijun Bao

OTHER

Sponsor Role: lead

Responsible Party

Zhijun Bao

Dean

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Huadong Hospital

Shanghai, , China

Countries

China

Other Identifiers

SHDC2024CRI080

Identifier Type: -

Identifier Source: org_study_id