Midgut Carcinoid TumorTNE-IDC-COLENCT04735198
Prophylactic Cholecystectomy in Midgut NETs Patients Who Require Primary Tumor Surgery.
A study testing Primary tumor surgery and Primary tumor surgery (bowel resection) combined with prophylactic cholecystectomy in people with Midgut Carcinoid Tumor and Biliary Stones, run by Hospital Universitari de Bellvitge at 6 sites in Spain.
Trial summary
The investigators want to study the effectiveness of prophylactic cholecystectomy in patients with midgut neuroendocrine tumor (jejunum, ileum or proximal colon) who require primary tumor surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Midgut Carcinoid Tumor, Biliary Stones
- What is being tested?
- Primary tumor surgery and Primary tumor surgery (bowel resection) combined with prophylactic cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 6 sitesSpain
- Study dates
- 20 Jan 2021to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must grant the informed consent written, signed and dated.
- Male or female older than 18 years old.
- Radiological or histological diagnose of midgut NET that can be treated with surgery.
- In case of female with childbearing age (time between menarche and menopause), a pregnancy test with negative result.
- Neuroendocrine tumors located in any of the aforementioned locations.
- Presence or not of distant metastasis.
- Presencié or not of gallstones.
- Capacity of follow up.
Who cannot join
- Neuroendocrine tumors which are not located in jejunum or ileum (bronchial, gastric, pancreatic, descending colon, sigma or rectum.).
- Patients that have gone through a previous bowel resection.
- Patients with previous cholecystectomy.
- Pacients with biliary stone disease.
- Patients who are candidate to liver resection or liver transplant.
- Patients with a gallbladder polyp bigger than 6 mm.
Show all 10Show fewer
- Pacients with one gallbladder sessile polyp, presence of more than one polyp or patients older than 50 years old with a polyp.
- Refusal to participate.
- Patients with previous history of malignant neoplasms in the last 5 years, except skin basal cell carcinoma, "in situ" cervical carcinoma or in situ carcinoma found in a polyp removed with a colonoscopy.
- Medical criteria that doesn't consider the patient a candidate to participate in the study.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Spain6 sites, 5 recruiting
- Not yet recruiting
Hospital Universitari Trias i Pujol
Badalona, Barcelona
Sandra Vela, sandravela1@gmail.com
- Recruiting
IDIBELL, Hospital Universitari de Bellvitge.
Barcelona, Barcelona, 08907
Inés Ginot, 696014147, inesginot@gmail.com
- Not yet recruiting
Hospital del Mar
Barcelona, Barcelona
Joan Altet, joanaltet@gmail.com
Joan Altet
- Not yet recruiting
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona
José Luís Sánchez, 30208jsg@comb.cat
- Active, not recruiting
Instituto Catalán de Oncología
L'Hospitalet de Llobregat, Barcelona
- Not yet recruiting
Hospital Universitario Gregorio Marañón
Madrid, Madrid
Luís Miguel Jiménez, luismijg@gmail.com
About this study
Official title: Effectiveness of Prophylactic Cholecystectomy in Patients With Midgut Neuroendocrine Tumor (Jejunum, Ileum or Proximal Colon) Who Require Primary Tumor Surgery. Randomized, Proof of Concept Clinical Trial.
The investigators want to study the effectiveness of prophylactic cholecystectomy in patients with midgut neuroendocrine tumor (jejunum, ileum or proximal colon) who require primary tumor surgery. When patients are diagnosed and are tributary to surgical treatment, the tumor might compromise vascularization, and patients need an extensive bowel resection. The patients might also receive medical treatment with somatostatin analogs. The combination of extensive bowel resection and medical treatment might increase gallbladder stones, but patients might not develop biliary stone disease, as in the general population, where 20% of the population have gallbladder stones but only a 10 to 15 % of the population will develop symptoms.
The idea comes from the lack of literature about the incidence of biliary Stone disease in patients with midgut NET tumors.
Read more
It's a multicentric, open-label and randomized clinical trial to evaluate the incidence of biliary stone disease in patients with midgut NET who require primary tumor surgery combined or not to cholecystectomy.
Our hypothesis suggests that patients with midgut neuroendocrine tumor who require primary tumor resection without the combination of prophylactic cholecystectomy do not have an increased incidence of biliary stone disease two years after the surgery, regardless of treatment with SSA.
Read the detailed description
Title: Effectiveness of prophylactic cholecystectomy in patients with midgut neuroendocrine tumor (jejunum, ileum or proximal colon) who require primary tumor surgery. Randomized, proof of concept clinical trial.
Background: The prevalence of midgut NET has increased due to advances in diagnostic tests and its indolent course. When patients are diagnosed, they might be tributary to surgical treatment requiring an extensive bowel resection, and medical treatment with somatostatin analogs. Both treatments are related with gallbladder stone formation. The ENETS and NANETs recommend prophylactic cholecystectomy in patients with midgut NET who require primary tumor surgery, However, there is a lack of scientific evidence reinforcing this recommendation.
Objectives: The main objective is to evaluate the cumulated incidence rate of biliary stone disease in patients with midgut NET who require primary tumor resection, two years after the surgery.
Design: It's a multicentric, open-label and randomized clinical trial. Patients will be recruited from the General Surgery Services of the six Hospitals participating in the study. Patients must fullfill inclusion and exclusion criteria.
It is expected to recruit a maximum of one hundred patients in two years (50 per group). Patients will be randomly assigned into the Experimental group (primary tumor resections) or Control group (primary tumor resections combined with cholecystectomy). The investigators will follow up patients until week 104 after surgery (8 visits).
- Conditions
- Midgut Carcinoid Tumor, Biliary Stones
- Being tested
- Primary tumor surgery, Primary tumor surgery (bowel resection) combined with prophylactic cholecystectomy
- Keywords
- Neuroendocrine tumor, prophylactic cholecystectomy, Biliary stone disease
- Medical subject headings
- Cholecystolithiasis, Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary tumor surgeryProcedure or surgery
Also called Bowel resection
Large bowel resection.
Primary tumor surgery (bowel resection) combined with prophylactic cholecystectomyProcedure or surgery
Also called prophylactic cholecystectomy.
Large bowel resection combined and cholecystectomy.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Active comparator | Patients with midgut neuroendocrine tumor who will undergo only primary tumor surgery. Receives: Procedure: Primary tumor surgery |
| Control group | Experimental | Patients with midgut neuroendocrine tumor that will undergo through primary tumor surgery combined with prophylactic cholecystectomy. Receives: Procedure: Primary tumor surgery; Procedure: Primary tumor surgery (bowel resection) combined with prophylactic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the rate of biliary stone disease associated to patients with midgut NET that have gone through primary tumor surgery.
Incidence of biliary stone disease in patients with midgut NET who requiere primary tumor surgery
Measured: Two years after the surgery
Secondary outcomes (6)
To assess the incidence of post-operative complications until day 28 +/- 3 (1 Month) after the surgery.
Postoperative complications according Clavien-Dindo classification
Measured: One month after the surgery
To assess the incidence of: anastomotic dehiscence, wound infection, reoperation.
Specific complications
Measured: One month after the surgery
To evaluate the incidence of gallstone in patients who require a bowel resection and/or ileocecal junction resection.
choledochal lithiasis or cholelithiasis
Measured: Two years after the surgery
To evaluate de incidence of gallstones in patients who will receive medical treatment with SSA
choledochal lithiasis or cholelithiasis according medical treatment
Measured: Two years after the surgery
To describe bowel movements of patients after the surgery.
Gastrointestinal Quality of Life Index (GIQLY);Minimum value of 0 (the worst health state) and a maximum of 100 (best health state)
Measured: Two years after the surgery
To compare quality of life in patients who went through a prophylactic cholecystectomy against those who did not.
Health related Quality of life 15 D (HRQoL 15D);There are 15 areas with a minimum value of 0 (the worst health state) and a maximum of 100 (best health state) 15D
Measured: Two years after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start20 Jan 2021
- Primary completion1 Dec 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Midgut Carcinoid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo Frago Montanuy, Hospital Universitari de Bellvitge
- Investigators
- Ricardo Frago Montanuy, Principal investigator, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735198
- Sponsor's protocol ID
- PR348/20
- Acronym
- TNE-IDC-COLE
- Status last verified
- May 2025
- First submitted
- 21 Jan 2021
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: That's not decided yet
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Prophylactic Cholecystectomy in Patients With Midgut Neuroendocrine Tumor (Jejunum, Ileum or Proximal Colon) Who Require Primary Tumor Surgery. Randomized, Proof of Concept Clinical Trial.
- ClinicalTrials.gov ID
- NCT04735198
- Acronym / sponsor ID
- TNE-IDC-COLE / PR348/20
- Conditions
- Midgut Carcinoid Tumor, Biliary Stones
- Keywords
- Neuroendocrine tumor, prophylactic cholecystectomy, Biliary stone disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 3 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators want to study the effectiveness of prophylactic cholecystectomy in patients with midgut neuroendocrine tumor (jejunum, ileum or proximal colon) who require primary tumor surgery. When patients are diagnosed and are tributary to surgical treatment, the tumor might compromise vascularization, and patients need an extensive bowel resection. The patients might also receive medical treatment with somatostatin analogs. The combination of extensive bowel resection and medical treatment might increase gallbladder stones, but patients might not develop biliary stone disease, as in the general population, where 20% of the population have gallbladder stones but only a 10 to 15 % of the population will develop symptoms.
The idea comes from the lack of literature about the incidence of biliary Stone disease in patients with midgut NET tumors.
It's a multicentric, open-label and randomized clinical trial to evaluate the incidence of biliary stone disease in patients with midgut NET who require primary tumor surgery combined or not to cholecystectomy.
Our hypothesis suggests that patients with midgut neuroendocrine tumor who require primary tumor resection without the combination of prophylactic cholecystectomy do not have an increased incidence of biliary stone disease two years after the surgery, regardless of treatment with SSA.
Detailed description
Title: Effectiveness of prophylactic cholecystectomy in patients with midgut neuroendocrine tumor (jejunum, ileum or proximal colon) who require primary tumor surgery. Randomized, proof of concept clinical trial.
Background: The prevalence of midgut NET has increased due to advances in diagnostic tests and its indolent course. When patients are diagnosed, they might be tributary to surgical treatment requiring an extensive bowel resection, and medical treatment with somatostatin analogs. Both treatments are related with gallbladder stone formation. The ENETS and NANETs recommend prophylactic cholecystectomy in patients with midgut NET who require primary tumor surgery, However, there is a lack of scientific evidence reinforcing this recommendation.
Objectives: The main objective is to evaluate the cumulated incidence rate of biliary stone disease in patients with midgut NET who require primary tumor resection, two years after the surgery.
Design: It's a multicentric, open-label and randomized clinical trial. Patients will be recruited from the General Surgery Services of the six Hospitals participating in the study. Patients must fullfill inclusion and exclusion criteria.
It is expected to recruit a maximum of one hundred patients in two years (50 per group). Patients will be randomly assigned into the Experimental group (primary tumor resections) or Control group (primary tumor resections combined with cholecystectomy). The investigators will follow up patients until week 104 after surgery (8 visits).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Active comparator | Procedure: Primary tumor surgeryPatients with midgut neuroendocrine tumor who will undergo only primary tumor surgery. |
| Control group | Experimental | Procedure: Primary tumor surgery, Procedure: Primary tumor surgery (bowel resection) combined with prophylactic cholecystectomyPatients with midgut neuroendocrine tumor that will undergo through primary tumor surgery combined with prophylactic cholecystectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients must grant the informed consent written, signed and dated.
- Male or female older than 18 years old.
- Radiological or histological diagnose of midgut NET that can be treated with surgery.
- In case of female with childbearing age (time between menarche and menopause), a pregnancy test with negative result.
- Neuroendocrine tumors located in any of the aforementioned locations.
Key exclusion criteria (10 listed)
- Neuroendocrine tumors which are not located in jejunum or ileum (bronchial, gastric, pancreatic, descending colon, sigma or rectum.).
- Patients that have gone through a previous bowel resection.
- Patients with previous cholecystectomy.
- Pacients with biliary stone disease.
- Patients who are candidate to liver resection or liver transplant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary tumor surgeryAlso: Bowel resectionLarge bowel resection. | Procedure or surgery | Control group, Experimental group |
| Primary tumor surgery (bowel resection) combined with prophylactic cholecystectomyAlso: prophylactic cholecystectomy.Large bowel resection combined and cholecystectomy. | Procedure or surgery | Control group |
Primary outcome
To evaluate the rate of biliary stone disease associated to patients with midgut NET that have gone through primary tumor surgery.
Time frame: Two years after the surgery
Incidence of biliary stone disease in patients with midgut NET who requiere primary tumor surgery
6 secondary outcomes
To assess the incidence of post-operative complications until day 28 +/- 3 (1 Month) after the surgery.
Time frame: One month after the surgery
To assess the incidence of: anastomotic dehiscence, wound infection, reoperation.
Time frame: One month after the surgery
To evaluate the incidence of gallstone in patients who require a bowel resection and/or ileocecal junction resection.
Time frame: Two years after the surgery
To evaluate de incidence of gallstones in patients who will receive medical treatment with SSA
Time frame: Two years after the surgery
To describe bowel movements of patients after the surgery.
Time frame: Two years after the surgery
To compare quality of life in patients who went through a prophylactic cholecystectomy against those who did not.
Time frame: Two years after the surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Individual participant dataSharing planned: No. That's not decided yet
Related trials for Midgut Carcinoid Tumor
Active, not recruitingPhase 2
Pazopanib Hydrochloride in Treating Patients With Progressive Carcinoid Tumors
Foregut Neuroendocrine Tumor, Hindgut Neuroendocrine Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ricardo Frago Montanuy principal investigator
Hospital Universitari de Bellvitge
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary tumor surgery and Primary tumor surgery (bowel resection) combined with prophylactic cholecystectomy in people with Midgut Carcinoid Tumor and Biliary Stones, run by Hospital Universitari de Bellvitge at 6 sites in Spain.
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 8 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Inés Ginot (696014147, inesginot@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the rate of biliary stone disease associated to patients with midgut NET that have gone through primary tumor surgery. (time frame: Two years after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2025.