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

NCT06685939 | Enrolling By Invitation

• 1 other identifier: SHDC2024CRI080
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

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

Keywords

pancreatic cancer; LPD; OPD; complication

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

OPD

The patients who received the OPD

Procedure: LPD

Interventions

LPD PROCEDURE

The patients who received the LPD

OPD

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhijun Bao: lead
• Ruijin Hospital: collaborator

Study Sites (1)

Huadong Hospital

Shanghai, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Pathological tissue,blood

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dean

Study Record Dates

• First Submitted: November 10, 2024
• First Posted: November 13, 2024
• Study Start: January 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: July 31, 2025
• Last Updated: November 13, 2024

Record last verified: 2024-11

Locations

CN (1)