The Differences of Complications Between LPD(Laparoscopic Pancreaticoduodenectomy) and OPD(Open Pancreaticoduodenectomy)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LPD.
- Who it may be relevant to
- Registry conditions: Pancreatic Neoplasms. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Procedure LPD
The patients who received the LPD
Primary outcome measures
- Overall survive [Time frame: from the day after surgery to 3 years]
- complication [Time frame: during the days Postoperative up to 1 year]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Huadong Hospital — Shanghai
Identifiers
NCT: NCT06685939 · SHDC2024CRI080