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InsulinomaNCT05523778

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

A study testing placement of pancreatic duct stents before enucleation surgery and Direct enucleation surgery in people with Insulinoma, run by Peking Union Medical College Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Insulinoma
What is being tested?
placement of pancreatic duct stents before enucleation surgery and Direct enucleation surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteChina
Study dates
6 Feb 2023to Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Qiang Xu, Doctor contact

+86-13810096103

xuqiang@pumch.cn

China1 site, 1 recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

    Qiang Xu, Doctor, +86-13810096103

    Recruiting

Other trials in China

About this study

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.

Read the 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.

Conditions
Insulinoma
Being tested
placement of pancreatic duct stents before enucleation surgery, Direct enucleation surgery
Keywords
Pancreatic enucleation, Pancreatic duct stent, Regular pancreatectomy, Health economics evaluation
Medical subject headings
Insulinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • placement of pancreatic duct stents before enucleation surgeryProcedure or surgery

    Advance placement of pancreatic stents endoscopically

  • Direct enucleation surgeryProcedure or surgery

    Patients will receive direct enucleation surgery

Study groups in NCT05523778
Study groupRoleWhat they receive
Stented ENExperimentalPatients are placed the pancreatic duct stent by endoscopist 1day or several hours before the enucleation surgery.
Receives: Procedure: placement of pancreatic duct stents before enucleation surgery
Direct ENActive comparatorPatients will receive enucleation surgery directly following normal procedure
Receives: Procedure: Direct enucleation surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of POPF within 3 months after EN.

    Postoperative clinically relevant pancreatic fistula in this study adopts the definition proposed by the international pancreatic surgery research group (ISGPS)

    Measured: 3 days to 3 months after enucleation (or the extubation time),up to 6 month after inclusion

Secondary outcomes (10)

  1. Rate of postoperative abdominal infection within 3 weeks after EN

    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.

    Measured: 3 days to 3 weeks after enucleation (or the extubation time),,up to 6 month after inclusion

  2. Rate of postoperative delayed gastric emptying within 3 weeks after EN

    Gastric emptying disorder can be diagnosed if the solid diet cannot be restored 1 week after operation and the gastric tube cannot be removed.

    Measured: 3 days to 3 weeks after enucleation (or the extubation time)

  3. Rate of postoperative hemorrhagepostpancreatectomy haemorrhage within 3 weeks after EN

    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.

    Measured: 1 days to 3 weeks after enucleation (or the extubation time),,up to 6 month after inclusion

  4. Rate of postoperative dyspepsia within 6 months after EN

    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:

    1. 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.

    Measured: 2 weeks to 6 months after enucleation,,up to 6 month after inclusion

  5. Rate of postoperative lung infection within 3 weeks after EN

    Patients with any of the following conditions:

    1. 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.

    Measured: 1 days to 3 weeks after enucleation (or the extubation time),,up to 6 month after inclusion

  6. Rate of postoperative hyperglycemia within 6 months after EN

    the diagnosis should meet at least one of the following requirements:

    1. 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.

    Measured: 2 weeks to 6 months after enucleation,,up to 6 month after inclusion

  7. Rate of post-stent-placement acute pancreatitis in Stented EN group within in 3 weeks after EN

    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)

    Measured: 1 days to 3 days after stent placement,,up to 6 month after inclusion

  8. Operation time

    Measured: Measure during operation,,up to 6 month after inclusion

  9. Intraoperative blood loss

    Measured: Measure during operation,,up to 6 month after inclusion

  10. Total cost of hospitalization

    Measured: Measure during the whole hospitalization procedure of each patient,,up to 6 month after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2022
  2. Study start6 Feb 2023
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05523778
Sponsor's protocol ID
PANCSTENTEN
Status last verified
Jul 2023
First submitted
16 Aug 2022
Last updated
2 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Gao R, Yin B, Jin J, Tian X, Zhang Y, Wei J, Cao F, Wang Z, Ma Z, Wang M, Gou S, Cong L, Xu Q, Wu W, Zhao Y. Preoperative pancreatic stent placement before the enucleation of insulinoma located in the head and neck of the pancreas in proximity to the main pancreatic duct: study protocol for a multicentre randomised clinical trial in Chinese tertiary medical centres. BMJ Open. 2024 Apr 2;14(4):e078516. doi: 10.1136/bmjopen-2023-078516.

    PubMed 38569703

Questions about this trial

What is this clinical trial studying?

A study testing placement of pancreatic duct stents before enucleation surgery and Direct enucleation surgery in people with Insulinoma, run by Peking Union Medical College Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Qiang Xu, Doctor (+86-13810096103, xuqiang@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05523778, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023; AzTrials last refreshed its copy on 29 Oct 2026.

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