Clinical trial NCT05523778: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insulinoma
Keywords: Pancreatic enucleation
Pancreatic duct stent
Regular pancreatectomy
Health economics evaluation
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Peking University First Hospital
name: Xuanwu Hospital, Beijing
name: First Affiliated Hospital Xi'an Jiaotong University
name: Ruijin Hospital
First posted: 2022-08-31
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Rate of POPF within 3 months after EN.
timeFrame: 3 days to 3 months after enucleation (or the extubation time),up to 6 month after inclusion
Secondary outcomes:
measure: Rate of postoperative abdominal infection within 3 weeks after EN
timeFrame: 3 days to 3 weeks after enucleation (or the extubation time),,up to 6 month after inclusion
measure: Rate of postoperative delayed gastric emptying within 3 weeks after EN
timeFrame: 3 days to 3 weeks after enucleation (or the extubation time)
measure: Rate of postoperative hemorrhagepostpancreatectomy haemorrhage within 3 weeks after EN
timeFrame: 1 days to 3 weeks after enucleation (or the extubation time),,up to 6 month after inclusion
measure: Rate of postoperative dyspepsia within 6 months after EN
timeFrame: 2 weeks to 6 months after enucleation,,up to 6 month after inclusion
measure: Rate of postoperative lung infection within 3 weeks after EN
timeFrame: 1 days to 3 weeks after enucleation (or the extubation time),,up to 6 month after inclusion
measure: Rate of postoperative hyperglycemia within 6 months after EN
timeFrame: 2 weeks to 6 months after enucleation,,up to 6 month after inclusion
measure: Rate of post-stent-placement acute pancreatitis in Stented EN group within in 3 weeks after EN
timeFrame: 1 days to 3 days after stent placement,,up to 6 month after inclusion
measure: Operation time
timeFrame: Measure during operation,,up to 6 month after inclusion
measure: Intraoperative blood loss
timeFrame: Measure during operation,,up to 6 month after inclusion
measure: Total cost of hospitalization
timeFrame: Measure during the whole hospitalization procedure of each patient,,up to 6 month after inclusion
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References: