NCT06685939Enrolling by invitation

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

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

Source: ClinicalTrials.gov · Last updated 13 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry): Enrolling by invitation
Study type: Observational
Enrollment: 220 (estimated)
First submitted: 10 Nov 2024
Start date: 1 Jan 2020
Primary completion date: 31 Dec 2022
Lead sponsor: Zhijun Bao
Diseases: Pancreatic cancer
NCT number: NCT06685939

What you commit to

Study type: Observational
Planned participants: 220
From 1 Jan 2020 to the primary completion date, 31 Dec 2022
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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;
MDT evaluates patients with vascular invasion and requiring vascular resection based on abdominal imaging data;

Other illness

A history of other malignant tumors;
Patients with severe mental disorders;

Other

Preoperative anesthesia ASA score of 4 points;
Pregnant or lactating women;
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.

Who the study is looking for

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.

Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Huadong Hospital Coordinator of this site? Confirm its status	Shanghai	China	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.