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Gastric Venous Reconstruction After Total Pancreatectomy

Gastric Venous Reconstruction to Reduce Gastric Venous Congestion After Total Pancreatectomy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04850430
Acronym
GENDER
Enrollment
20
Registered
2021-04-20
Start date
2024-02-01
Completion date
2025-12-01
Last updated
2023-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreas Cancer, Pancreatectomy

Keywords

Pancreatectomy, Gastric venous outflow reconstruction, Gastric venous congestion

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.

Interventions

PROCEDUREGastric venous reconstruction

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.

Sponsors

University Hospital Heidelberg
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of gastric venous congestion30 days postoperativeGastric venous congestion after gastric venous reconstruction following total pancreatectomy
Incidence of gastric ischemia30 days postoperativeGastric ischemia after gastric venous reconstruction following total pancreatectomy
Postpancreatectomy gastrectomy rate30 days postoperativeRate of gastrectomy after gastric venous reconstruction following total pancreatectomy
Reoperation rate30 days postoperativeReoperation rate after gastric venous reconstruction following total pancreatectomy
Morbidity rate30 days postoperativeComplications rate after gastric venous reconstruction following total pancreatectomy
Mortality rate30 days postoperativeMortality rate after gastric venous reconstruction following total pancreatectomy

Countries

Germany

Contacts

Primary ContactArianeb Mehrabi, MD
arianeb.mehrabi@med.uni-heidelberg.de004962215636223

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026