Insulinoma
Conditions
Keywords
Pancreatic enucleation, Pancreatic duct stent, Regular pancreatectomy, Health economics evaluation
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.
Interventions
PROCEDUREplacement of pancreatic duct stents before enucleation surgery
Advance placement of pancreatic stents endoscopically
PROCEDUREDirect enucleation surgery
Patients will receive direct enucleation surgery
Sponsors
Peking University First Hospital
Xuanwu Hospital, Beijing
First Affiliated Hospital Xi'an Jiaotong University
Ruijin Hospital
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors are kept blinded to participant group allocation. Objective clinical data are provided to independent assessors with blindness of allocation. With clear definition for each endpoints, assessors are able to make grading for complications in primary and secondary endpoints
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of POPF within 3 months after EN. | 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
| Measure | Time frame | Description |
|---|---|---|
| Rate of postoperative delayed gastric emptying within 3 weeks after EN | 3 days to 3 weeks after enucleation (or the extubation time) | Gastric emptying disorder can be diagnosed if the solid diet cannot be restored 1 week after operation and the gastric tube cannot be removed. |
| 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 | Postoperative hemorrhage refers to the occurrence of bloody fluid in the abdominal drainage tube or gastrointestinal decompression tube, which can also be manifested as blood in the stool, accompanied by changes in vital signs such as heart rate and blood pressure, as well as a decrease in hemoglobin concentration. |
| Rate of postoperative dyspepsia within 6 months after EN | 2 weeks to 6 months after enucleation,,up to 6 month after inclusion | According to Rome IV standard, the diagnosis should meet the following requirements: Symptoms appear for at least 2 months, and must include one or more of the following uncomfortable symptoms, and at least 4 times a month: a. fullness after meals; b. Early satiety; c. Epigastric pain or burning sensation has nothing to do with defecation; d. After proper evaluation, the symptoms cannot be completely explained by other disease conditions. |
| 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 | Patients with any of the following conditions: a. continuous fever or leukocytosis, accompanied by postoperative chest X-ray or chest CT positive findings (consolidation of lung, pneumonia, atelectasis, with or without pleural effusion), and decreased body temperature after antibiotics; b. Sputum culture is positive, accompanied by continuous fever or leukocyte elevation, and body temperature drops after antibiotics; c. Pleural effusion affects the patient's breathing and requires pleural puncture and drainage. |
| 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 | Abdominal infection can be basically diagnosed if one of the following conditions occurs: 1. After 3 days of operation, the patient developed chills, high fever, abdominal distension, intestinal paralysis, etc., which lasted for more than 24 hours. The laboratory examination results showed that the leukocyte count increased significantly, with or without hypoproteinemia and anemia, and the imaging images showed the accumulation of fluid in the abdominal cavity; 2. The aspiration fluid was purulent or bacteria were detected in the fluid; 3. The infection was localized and formed inclusion. In imaging, fluid accumulation foci with clear edges and with or without gas could be seen. |
| 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 | Patients with any two of the following three criteria can be diagnosed : a. abdominal pain consistent with the onset; b. Biochemical evidence of pancreatitis (serum amylase and / or lipase greater than 3 times the upper limit of normal); c. Typical manifestations of abdominal image (pancreatic edema / necrosis or exudation and effusion around the pancreas) |
| Operation time | Measure during operation,,up to 6 month after inclusion | — |
| Intraoperative blood loss | Measure during operation,,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 | — |
| Rate of postoperative hyperglycemia within 6 months after EN | 2 weeks to 6 months after enucleation,,up to 6 month after inclusion | the diagnosis should meet at least one of the following requirements: a. hemoglobin A1c (HbA1c) value ≥ 6.5%; b. If the fasting blood glucose is ≥ 126mg / dl, the test should be repeated on another day. Fasting is defined as at least 8 hours without calorie intake; c. Oral glucose tolerance test (OGTT), plasma glucose ≥ 200 mg / dl at 2 hours after 75g (100g for pregnant women) glucose load; d. Hyperglycemic symptoms and accidental (random) plasma glucose ≥ 200mg / dl. |
Countries
China
Contacts
Primary ContactQiang Xu, Doctor
Outcome results
None listed