Gastric Venous Reconstruction After Total Pancreatectomy

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

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NCT-Nummer:
NCT04850430

Studienbeginn:
Februar 2024

Letztes Update:
13.12.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Pancreatic Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital Heidelberg

Collaborator:
-

Kontakt

Arianeb Mehrabi, MD
Kontakt:
Phone: 004962215636223
E-Mail: arianeb.mehrabi@med.uni-heidelberg.de» Kontaktdaten anzeigen

Studienlocations
(2 von 2)

Surgery clinic
69493 Heidelberg
(Baden-Württemberg)
Germany» Google-Maps
Ansprechpartner:
Arianeb Mehrabi
Phone: 004962215636223
E-Mail: arianeb.mehrabi@med.uni-heidelberg.de» Ansprechpartner anzeigen

Professor Dr. med. Arianeb Mehrabi
Heidelberg
(Baden-Württemberg)
Germany» Google-Maps
Ansprechpartner:
Arianeb Mehrabi
Phone: 004962215636223
E-Mail: arianeb.mehrabi@med.uni-heidelberg.de» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Incidence of gastric venous congestion (Time Frame - 30 days postoperative):
Gastric venous congestion after gastric venous reconstruction following total pancreatectomy

2. Incidence of gastric ischemia (Time Frame - 30 days postoperative):
Gastric ischemia after gastric venous reconstruction following total pancreatectomy

3. Postpancreatectomy gastrectomy rate (Time Frame - 30 days postoperative):
Rate of gastrectomy after gastric venous reconstruction following total pancreatectomy

4. Reoperation rate (Time Frame - 30 days postoperative):
Reoperation rate after gastric venous reconstruction following total pancreatectomy

5. Morbidity rate (Time Frame - 30 days postoperative):
Complications rate after gastric venous reconstruction following total pancreatectomy

6. Mortality rate (Time Frame - 30 days postoperative):
Mortality rate after gastric venous reconstruction following total pancreatectomy

Geprüfte Regime

Gastric 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.

Quelle: ClinicalTrials.gov

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