Clinical trial NCT06685939: The Differences of Complications Between LPD(Laparoscopic Pancreaticoduodenectomy) and OPD(Open Pancreaticoduodenectomy)
Official 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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Pancreatic Neoplasms
Keywords: pancreatic cancer
LPD
OPD
complication
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Ruijin Hospital
First posted: 2024-11-13
Enrollment: 220
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.


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.

Primary outcomes:
measure: Overall survive
timeFrame: from the day after surgery to 3 years
measure: complication
timeFrame: during the days Postoperative up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huadong Hospital
Study officials:
References: