Pancreas CancerGENDERNCT04850430
Gastric Venous Reconstruction After Total Pancreatectomy
A study testing Gastric venous reconstruction in people with Pancreas Cancer and Pancreatectomy, run by University Hospital Heidelberg at 2 sites in Germany.
Trial summary
Total pancreatoduodenectomy (TP) is the standard surgical approach for treatment of extended pancreas tumors. If the gastric coronary vein has to be sacrificed for oncologic or for technical reasons in total pancreatectomy with splenectomy, gastric venous congestion (GVC) may result because all major venous draining… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer, Pancreatectomy
- What is being tested?
- Gastric venous reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Feb 2024to 1 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Provide written informed consent
- Elective total pancreatectomy for malignant or benign pancreatic lesions or chronic pancreatitis with splenectomy
- Intraoperative ligation of coronary vein
Who cannot join
- Gastric resection due to malignant infiltration
- Non-reconstructable gastric venous drainage
- Previous pancreas surgery
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Surgery clinic
Heidelberg, 69493
Arianeb Mehrabi, 004962215636223, arianeb.mehrabi@med.uni-heidelberg.de
Professor Dr. med. Arianeb Mehrabi
Heidelberg
Arianeb Mehrabi, 004962215636223, arianeb.mehrabi@med.uni-heidelberg.de
About this study
Official title: Gastric Venous Reconstruction to Reduce Gastric Venous Congestion After Total Pancreatectomy
Total pancreatoduodenectomy (TP) is the standard surgical approach for treatment of extended pancreas tumors. If the gastric coronary vein has to be sacrificed for oncologic or for technical reasons in total pancreatectomy with splenectomy, gastric venous congestion (GVC) may result because all major venous draining routes are terminated. In the sequelae of GVC, gastric venous infarction ultimately leads to gastric perforation with abdominal sepsis. To avoid gastric venous infarction, partial or even total gastrectomy is usually performed in the event of GVC after TP. However, this significantly impacts the patient's quality of life.
Reconstruction of gastric venous outflow represents a technical approach to overcome GVC and to avoid gastric venous infarction making (partial) gastrectomy unnecessary. The current study aims to assess the role of gastric venous outflow reconstruction in GVC after TP to prevent (partial) gastrectomy.
- Conditions
- Pancreas Cancer, Pancreatectomy
- Being tested
- Gastric venous reconstruction
- Keywords
- Pancreatectomy, Gastric venous outflow reconstruction, Gastric venous congestion
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric venous reconstructionProcedure or surgery
Patients will be assigned to study after intraoperative evaluation of gastric venous drainage after coronary vein resection during TP, and the gastric venous outflow will be reconstructed after TP.
| Study group | Role | What they receive |
|---|---|---|
| Gastric venous congestion following total pancreatectomy | Experimental | The gastric venous outflow will be reconstructed after TP. The patients will be assessed concerning gastric venous congestion and gastric ischemia intraoperatively before and after venous outflow reconstruction through onsite evaluation by the surgeon, endoscopic examination, indocyanine green, gastric venous drainage flowmetry, and spectral imaging. Receives: Procedure: Gastric venous reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of gastric venous congestion
Gastric venous congestion after gastric venous reconstruction following total pancreatectomy
Measured: 30 days postoperative
Incidence of gastric ischemia
Gastric ischemia after gastric venous reconstruction following total pancreatectomy
Measured: 30 days postoperative
Postpancreatectomy gastrectomy rate
Rate of gastrectomy after gastric venous reconstruction following total pancreatectomy
Measured: 30 days postoperative
Reoperation rate
Reoperation rate after gastric venous reconstruction following total pancreatectomy
Measured: 30 days postoperative
Morbidity rate
Complications rate after gastric venous reconstruction following total pancreatectomy
Measured: 30 days postoperative
Mortality rate
Mortality rate after gastric venous reconstruction following total pancreatectomy
Measured: 30 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start1 Feb 2024 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients will be assigned to study after intraoperative evaluation of gastric venous drainage after coronary vein resection during TP. During surgery, onsite evaluation by the surgeon, endoscopic examination, indocyanine green, gastric venous drainage flowmetry, and spectral analysis will be performed. After surgery, patients will receive standard post-TP care and treatment. During hospitalization, endoscopic examination with indocyanine green will be performed on the first, third, and seventh postoperative day to evaluate gastric ischemia. Ischemia markers will be evaluated daily after surgery. After discharge, patients will be followed up for 30 days, during which mortality and morbidities will be recorded.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arianeb Mehrabi, MD, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04850430
- Sponsor's protocol ID
- S-173/2021
- Acronym
- GENDER
- Status last verified
- Dec 2023
- First submitted
- 14 Apr 2021
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon reasonable request, the data generated by the current research that supports our future article, would be made available as soon as possible, wherever legally and ethically possible.
Publications
Mehrabi A, Loos M, Ramouz A, Dooghaie Moghadam A, Probst P, Nickel F, Schaible A, Mieth M, Hackert T, Buchler MW. Gastric venous reconstruction to reduce gastric venous congestion after total pancreatectomy: study protocol of a single-centre prospective non-randomised observational study (IDEAL Phase 2A) - GENDER study (Gastric vENous DrainagE Reconstruction). BMJ Open. 2021 Oct 21;11(10):e052745. doi: 10.1136/bmjopen-2021-052745.
PubMed 34675020
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Venous Reconstruction to Reduce Gastric Venous Congestion After Total Pancreatectomy
- ClinicalTrials.gov ID
- NCT04850430
- Acronym / sponsor ID
- GENDER / S-173/2021
- Conditions
- Pancreas Cancer, Pancreatectomy
- Keywords
- Pancreatectomy, Gastric venous outflow reconstruction, Gastric venous congestion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 20 Apr 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.
Total pancreatoduodenectomy (TP) is the standard surgical approach for treatment of extended pancreas tumors. If the gastric coronary vein has to be sacrificed for oncologic or for technical reasons in total pancreatectomy with splenectomy, gastric venous congestion (GVC) may result because all major venous draining routes are terminated. In the sequelae of GVC, gastric venous infarction ultimately leads to gastric perforation with abdominal sepsis. To avoid gastric venous infarction, partial or even total gastrectomy is usually performed in the event of GVC after TP. However, this significantly impacts the patient's quality of life.
Reconstruction of gastric venous outflow represents a technical approach to overcome GVC and to avoid gastric venous infarction making (partial) gastrectomy unnecessary. The current study aims to assess the role of gastric venous outflow reconstruction in GVC after TP to prevent (partial) gastrectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients will be assigned to study after intraoperative evaluation of gastric venous drainage after coronary vein resection during TP. During surgery, onsite evaluation by the surgeon, endoscopic examination, indocyanine green, gastric venous drainage flowmetry, and spectral analysis will be performed. After surgery, patients will receive standard post-TP care and treatment. During hospitalization, endoscopic examination with indocyanine green will be performed on the first, third, and seventh postoperative day to evaluate gastric ischemia. Ischemia markers will be evaluated daily after surgery. After discharge, patients will be followed up for 30 days, during which mortality and morbidities will be recorded.
| Arm | Type | Receives |
|---|---|---|
| Gastric venous congestion following total pancreatectomy | Experimental | Procedure: Gastric venous reconstructionThe gastric venous outflow will be reconstructed after TP. The patients will be assessed concerning gastric venous congestion and gastric ischemia intraoperatively before and after venous outflow reconstruction through onsite evaluation by the surgeon, endoscopic examination, indocyanine green, gastric venous drainage flowmetry, and spectral imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Provide written informed consent
- Elective total pancreatectomy for malignant or benign pancreatic lesions or chronic pancreatitis with splenectomy
- Intraoperative ligation of coronary vein
Key exclusion criteria (3 listed)
- Gastric resection due to malignant infiltration
- Non-reconstructable gastric venous drainage
- Previous pancreas surgery
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 |
|---|---|---|
| Gastric venous reconstructionPatients will be assigned to study after intraoperative evaluation of gastric venous drainage after coronary vein resection during TP, and the gastric venous outflow will be reconstructed after TP. | Procedure or surgery | Gastric venous congestion following total pancreatectomy |
Primary outcome
Incidence of gastric venous congestion
Time frame: 30 days postoperative
Gastric venous congestion after gastric venous reconstruction following total pancreatectomy
Incidence of gastric ischemia
Time frame: 30 days postoperative
Gastric ischemia after gastric venous reconstruction following total pancreatectomy
Postpancreatectomy gastrectomy rate
Time frame: 30 days postoperative
Rate of gastrectomy after gastric venous reconstruction following total pancreatectomy
Reoperation rate
Time frame: 30 days postoperative
Reoperation rate after gastric venous reconstruction following total pancreatectomy
Morbidity rate
Time frame: 30 days postoperative
Complications rate after gastric venous reconstruction following total pancreatectomy
Mortality rate
Time frame: 30 days postoperative
Mortality rate after gastric venous reconstruction following total pancreatectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Derived from this study: PubMed 34675020Mehrabi A, Loos M, Ramouz A, Dooghaie Moghadam A, Probst P, Nickel F, Schaible A, Mieth M, Hackert T, Buchler MW. Gastric venous reconstruction to reduce gastric venous congestion after total pancreatectomy: study protocol of a single-centre prospective non-randomised observational study (IDEAL Phase 2A) - GENDER study (Gastric vENous DrainagE Reconstruction). BMJ Open. 2021 Oct 21;11(10):e052745. doi: 10.1136/bmjopen-2021-052745.
- Individual participant dataSharing planned: Yes. Upon reasonable request, the data generated by the current research that supports our future article, would be made available as soon as possible, wherever legally and ethically possible.
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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. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric venous reconstruction in people with Pancreas Cancer and Pancreatectomy, run by University Hospital Heidelberg at 2 sites in Germany.
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 3 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 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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 Arianeb Mehrabi, MD (004962215636223, arianeb.mehrabi@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of gastric venous congestion (time frame: 30 days postoperative). The study lists 6 primary outcomes in all. 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 NCT04850430, 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 13 Dec 2023.