Clinical trial NCT04850430: Gastric Venous Reconstruction After Total Pancreatectomy
Official title: Gastric Venous Reconstruction to Reduce Gastric Venous Congestion After Total Pancreatectomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pancreas Cancer
Pancreatectomy
Keywords: Pancreatectomy
Gastric venous outflow reconstruction
Gastric venous congestion
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2021-04-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Incidence of gastric venous congestion
timeFrame: 30 days postoperative
measure: Incidence of gastric ischemia
timeFrame: 30 days postoperative
measure: Postpancreatectomy gastrectomy rate
timeFrame: 30 days postoperative
measure: Reoperation rate
timeFrame: 30 days postoperative
measure: Morbidity rate
timeFrame: 30 days postoperative
measure: Mortality rate
timeFrame: 30 days postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Surgery clinic
city: Heidelberg
country: Germany
facility: Professor Dr. med. Arianeb Mehrabi
Study officials:
References:
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.