A Multi-center Study to Evaluate the Efficacy and Safety of Pancreatic Duct Stents Placement Before the Enucleation of Insulinoma Located in the Head and Neck of the Pancreas Near the Main Pancreatic Duct
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Insulinoma
- Sponsor
- Peking Union Medical College Hospital
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Rate of POPF within 3 months after EN.
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to compare the clinical efficacy and economic cost of enucleation after placement of pancreatic duct stents before surgery with that of direct enucleation alone, and to evaluate its safety and feasibility.
Detailed Description
The research contents of this study include: patients with insulinoma near the main pancreatic duct in the head and neck of the pancreas were randomly divided into two groups: the preoperative pancreatic duct stent enucleation group (stended EN), the direct en group (DEN), the Sen group asked a digestive endoscopist to place the pancreatic duct stent before surgery, and the next day or the next day after surgery, and the den group received enucleation directly. The safety of the two groups was compared, including the evaluation of surgical effect Postoperative complications and long-term prognosis based on follow-up data analysis; At the same time, the differences between the two groups were evaluated from the perspective of health economics.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The clinical qualitative diagnosis of insulinoma was clear;
- •The localization diagnosis was clear, and it was determined that the tumor was single, located in the head and neck;
- •The distance between the tumor and the main pancreatic duct was determined to be ≤ 2mm by preoperative imaging (enhanced CT, MRI, etc.);
- •Truly informed and voluntarily participate in this study.
Exclusion Criteria
- •Maximum diameter of the tumor \>2cm proved pathologically
- •Severe cardiopulmonary complications before operation
- •Combined with other known tumor diseases
- •Insulinoma is invasive or has suspicious metastatic lesions
- •Previous upper abdominal surgery history
- •Refusal or inability to cooperate in the study
Outcomes
Primary Outcomes
Rate of POPF within 3 months after EN.
Time Frame: 3 days to 3 months after enucleation (or the extubation time),up to 6 month after inclusion
Postoperative clinically relevant pancreatic fistula in this study adopts the definition proposed by the international pancreatic surgery research group (ISGPS)
Secondary Outcomes
- Rate of postoperative lung infection within 3 weeks after EN(1 days to 3 weeks after enucleation (or the extubation time),,up to 6 month after inclusion)
- Rate of postoperative dyspepsia within 6 months after EN(2 weeks to 6 months after enucleation,,up to 6 month after inclusion)
- Operation time(Measure during operation,,up to 6 month after inclusion)
- Intraoperative blood loss(Measure during operation,,up to 6 month after inclusion)
- Rate of postoperative delayed gastric emptying within 3 weeks after EN(3 days to 3 weeks after enucleation (or the extubation time))
- Rate of postoperative hemorrhagepostpancreatectomy haemorrhage within 3 weeks after EN(1 days to 3 weeks after enucleation (or the extubation time),,up to 6 month after inclusion)
- Rate of post-stent-placement acute pancreatitis in Stented EN group within in 3 weeks after EN(1 days to 3 days after stent placement,,up to 6 month after inclusion)
- Rate of postoperative abdominal infection within 3 weeks after EN(3 days to 3 weeks after enucleation (or the extubation time),,up to 6 month after inclusion)
- Rate of postoperative hyperglycemia within 6 months after EN(2 weeks to 6 months after enucleation,,up to 6 month after inclusion)
- Total cost of hospitalization(Measure during the whole hospitalization procedure of each patient,,up to 6 month after inclusion)