Back to resultsA 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
Primary Purpose
Insulinoma
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
placement of pancreatic duct stents before enucleation surgery
Direct enucleation surgery
Sponsored by
About this trial
This is an interventional treatment trial for Insulinoma focused on measuring Pancreatic enucleation, Pancreatic duct stent, Regular pancreatectomy, Health economics evaluation
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:
- 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
Sites / Locations
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Stented EN
Direct EN
Arm Description
Patients are placed the pancreatic duct stent by endoscopist 1day or several hours before the enucleation surgery.
Patients will receive enucleation surgery directly following normal procedure
Outcomes
Primary Outcome Measures
Incidence of postoperative clinically relevant pancreatic fistula
Postoperative clinically relevant pancreatic fistula in this study adopts the definition proposed by the international pancreatic surgery research group (ISGPS)
Secondary Outcome Measures
Incidence of postoperative abdominal infection
Abdominal infection can be basically diagnosed if one of the following conditions occurs:
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;
The aspiration fluid was purulent or bacteria were detected in the fluid;
The infection was localized and formed inclusion. In imaging, fluid accumulation foci with clear edges and with or without gas could be seen.
Incidence of postoperative gastric emptying disorder
Gastric emptying disorder can be diagnosed if the solid diet cannot be restored 1 week after operation and the gastric tube cannot be removed.
Incidence of postoperative hemorrhage
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.
Incidence of postoperative functional dyspepsia
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.
Incidence of postoperative pulmonary infection
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.
Incidence of postoperative diabetes
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.
Incidence of post-stent-placement pancreatitis in the experimental group
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
Intraoperative blood loss
Total cost of hospitalization
Full Information
NCT ID
NCT05523778
First Posted
August 16, 2022
Last Updated
August 10, 2023
Sponsor
Peking Union Medical College Hospital
Collaborators
Peking University First Hospital, Xuanwu Hospital, Beijing, First Affiliated Hospital Xi'an Jiaotong University, Ruijin Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05523778
Brief 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
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 19, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
Collaborators
Peking University First Hospital, Xuanwu Hospital, Beijing, First Affiliated Hospital Xi'an Jiaotong University, Ruijin Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulinoma
Keywords
Pancreatic enucleation, Pancreatic duct stent, Regular pancreatectomy, Health economics evaluation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stented EN
Arm Type
Experimental
Arm Description
Patients are placed the pancreatic duct stent by endoscopist 1day or several hours before the enucleation surgery.
Arm Title
Direct EN
Arm Type
Active Comparator
Arm Description
Patients will receive enucleation surgery directly following normal procedure
Intervention Type
Procedure
Intervention Name(s)
placement of pancreatic duct stents before enucleation surgery
Intervention Description
Advance placement of pancreatic stents endoscopically
Intervention Type
Procedure
Intervention Name(s)
Direct enucleation surgery
Intervention Description
Patients will receive direct enucleation surgery
Primary Outcome Measure Information:
Title
Incidence of postoperative clinically relevant pancreatic fistula
Description
Postoperative clinically relevant pancreatic fistula in this study adopts the definition proposed by the international pancreatic surgery research group (ISGPS)
Time Frame
3 days to 3 weeks after enucleation (or the extubation time),up to 6 month after inclusion
Secondary Outcome Measure Information:
Title
Incidence of postoperative abdominal infection
Description
Abdominal infection can be basically diagnosed if one of the following conditions occurs:
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;
The aspiration fluid was purulent or bacteria were detected in the fluid;
The infection was localized and formed inclusion. In imaging, fluid accumulation foci with clear edges and with or without gas could be seen.
Time Frame
3 days to 3 weeks after enucleation (or the extubation time),,up to 6 month after inclusion
Title
Incidence of postoperative gastric emptying disorder
Description
Gastric emptying disorder can be diagnosed if the solid diet cannot be restored 1 week after operation and the gastric tube cannot be removed.
Time Frame
3 days to 3 weeks after enucleation (or the extubation time)
Title
Incidence of postoperative hemorrhage
Description
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.
Time Frame
1 days to 3 weeks after enucleation (or the extubation time),,up to 6 month after inclusion
Title
Incidence of postoperative functional dyspepsia
Description
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.
Time Frame
2 weeks to 6 months after enucleation,,up to 6 month after inclusion
Title
Incidence of postoperative pulmonary infection
Description
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.
Time Frame
1 days to 3 weeks after enucleation (or the extubation time),,up to 6 month after inclusion
Title
Incidence of postoperative diabetes
Description
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.
Time Frame
2 weeks to 6 months after enucleation,,up to 6 month after inclusion
Title
Incidence of post-stent-placement pancreatitis in the experimental group
Description
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)
Time Frame
1 days to 3 days after stent placement,,up to 6 month after inclusion
Title
Operation time
Time Frame
Measure during operation,,up to 6 month after inclusion
Title
Intraoperative blood loss
Time Frame
Measure during operation,,up to 6 month after inclusion
Title
Total cost of hospitalization
Time Frame
Measure during the whole hospitalization procedure of each patient,,up to 6 month after inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qiang Xu, Doctor
Phone
+86-13810096103
Email
xuqiang@pumch.cn
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiang Xu, Doctor
Phone
+86-13810096103
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data obtained through this study may be provided to qualified researchers with academic interest in the surgical treatment of insulinoma. Data shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
IPD Sharing Time Frame
Data requests can be submitted starting 12 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis."Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
IPD Sharing Access Criteria
Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
Learn more about this trial
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
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