Gastric Venous Reconstruction After Total Pancreatectomy (GENDER)
Primary Purpose
Pancreas Cancer, Pancreatectomy
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Gastric venous reconstruction
Sponsored by
About this trial
This is an interventional prevention trial for Pancreas Cancer focused on measuring Pancreatectomy, Gastric venous outflow reconstruction, Gastric venous congestion
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Gastric resection due to malignant infiltration
- Non-reconstructable gastric venous drainage
- Previous pancreas surgery
Sites / Locations
- Surgery clinicRecruiting
- Professor Dr. med. Arianeb MehrabiRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gastric venous congestion following total pancreatectomy
Arm Description
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.
Outcomes
Primary Outcome Measures
Incidence of gastric venous congestion
Gastric venous congestion after gastric venous reconstruction following total pancreatectomy
Incidence of gastric ischemia
Gastric ischemia after gastric venous reconstruction following total pancreatectomy
Postpancreatectomy gastrectomy rate
Rate of gastrectomy after gastric venous reconstruction following total pancreatectomy
Reoperation rate
Reoperation rate after gastric venous reconstruction following total pancreatectomy
Morbidity rate
Complications rate after gastric venous reconstruction following total pancreatectomy
Mortality rate
Mortality rate after gastric venous reconstruction following total pancreatectomy
Secondary Outcome Measures
Full Information
NCT ID
NCT04850430
First Posted
April 14, 2021
Last Updated
September 29, 2021
Sponsor
University Hospital Heidelberg
1. Study Identification
Unique Protocol Identification Number
NCT04850430
Brief Title
Gastric Venous Reconstruction After Total Pancreatectomy
Acronym
GENDER
Official Title
Gastric Venous Reconstruction to Reduce Gastric Venous Congestion After Total Pancreatectomy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Heidelberg
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Cancer, Pancreatectomy
Keywords
Pancreatectomy, Gastric venous outflow reconstruction, Gastric venous congestion
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gastric venous congestion following total pancreatectomy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Gastric venous reconstruction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of gastric venous congestion
Description
Gastric venous congestion after gastric venous reconstruction following total pancreatectomy
Time Frame
30 days postoperative
Title
Incidence of gastric ischemia
Description
Gastric ischemia after gastric venous reconstruction following total pancreatectomy
Time Frame
30 days postoperative
Title
Postpancreatectomy gastrectomy rate
Description
Rate of gastrectomy after gastric venous reconstruction following total pancreatectomy
Time Frame
30 days postoperative
Title
Reoperation rate
Description
Reoperation rate after gastric venous reconstruction following total pancreatectomy
Time Frame
30 days postoperative
Title
Morbidity rate
Description
Complications rate after gastric venous reconstruction following total pancreatectomy
Time Frame
30 days postoperative
Title
Mortality rate
Description
Mortality rate after gastric venous reconstruction following total pancreatectomy
Time Frame
30 days postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Gastric resection due to malignant infiltration
Non-reconstructable gastric venous drainage
Previous pancreas surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arianeb Mehrabi, MD
Phone
004962215636223
Email
arianeb.mehrabi@med.uni-heidelberg.de
Facility Information:
Facility Name
Surgery clinic
City
Heidelberg
ZIP/Postal Code
69493
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arianeb Mehrabi
Phone
004962215636223
Email
arianeb.mehrabi@med.uni-heidelberg.de
Facility Name
Professor Dr. med. Arianeb Mehrabi
City
Heidelberg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arianeb Mehrabi
Phone
004962215636223
Email
arianeb.mehrabi@med.uni-heidelberg.de
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
34675020
Citation
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.
Results Reference
derived
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Gastric Venous Reconstruction After Total Pancreatectomy
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