The Comparision of Minimally-invasive and Open Pancreaticoduodenectomy for Pancreatic Cancer
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: Minimally-invasive pancreaticoduodenectomy, Open pancreaticoduodenectomy.
- Who it may be relevant to
- Registry conditions: Pancreatic Carcinoma, Surgery. Basic parameters: 18 years — 75 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
The Effect and Safety of Comparision Between Minimally-invasive and Open Pancreaticoduodenectomy for Pancreatic Cancer : A Randomized Prospective Trial
Overview
Minimally invasive pancreaticoduodenectomy remains one of the most challenging abdominal procedures. Safety and feasibility remain controversial when comparing minimally-invasive with open pancreaticoduodenectomy, especially for malignant tumors.The aim of this study was to compare minimally invasive and open pancreatoduodenectomy for short-term outcomes and long-term follow-up in a randomized trial.
Detailed description
This study is to compare the efficiency and safety between minimally invasive (including laparoscopic and robotic) and open pancreaticoduodenectomy for pancreatic cancer. We design a prospective randomized study. Patients with malignant pancreatic tumor who underwent pancreatoduodenectomy are recruited to the study. After obtaining informed consent, eligible patients are randomly allocated to minimally-invasive or open group before the operation day. The outcomes evaluated were hospital stay, and blood loss, radicality of surgery, duration of operation and complication rate as well as disease free survival and overall survival.
Interventions
- Procedure Minimally-invasive pancreaticoduodenectomy
Minimally-invasive pancreaticoduodenectomy for resection of pancreatic tumor - Other Open pancreaticoduodenectomy
Open pancreaticoduodenectomy for resection of pancreatic tumor
Primary outcome measures
- Overall complications [Time frame: Up to postoperative 30 days]
- Pancreatic fistula [Time frame: Up to postoperative 30 days]
- Intra-abdominal bleeding [Time frame: Up to postoperative 30 days]
- Intra-abdominal infection [Time frame: Up to postoperative 30 days]
Secondary outcome measures (1)
- Length of hospital stay (day) [Time frame: Up to postoperative 2 weeks]
Eligibility criteria
Inclusion criteria
- Age: >18yr, <75yr
- Patients with pancreatic cancer or non-pancreatic cancers (biliary duct cancer or ampullary cancer) who underwent pancreatoduodenectomy
- Preoperative imaging assessment is resectable or borderline resectable
Exclusion criteria
- Benign tumors of the head of pancreas
- Enhanced CT diagnosis revealed that the excess of SMV was more than 180 degrees, or distant metastasis.
- conversion to laparotomy because of intraoperative difficulty
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Chinese Academy of Medical Sciences & Peking Union Medical College Hospital — Beijing
Identifiers
NCT: NCT03747588 · Pumch06342