1 Mehrabi A, et al. BMJ Open 2021;11:e052745. doi:10.1136/bmjopen-2021-052745 Open access 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) Arianeb Mehrabi , 1 Martin Loos, 1 Ali Ramouz, 1 Arash Dooghaie Moghadam, 1 Pascal Probst , 1,2 Felix Nickel, 1 Anja Schaible, 1 Markus Mieth, 1 Thilo Hackert, 1 Markus W Büchler 1 To cite: Mehrabi A, Loos M, Ramouz A, et al. 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;11:e052745. doi:10.1136/ bmjopen-2021-052745 ► Prepublication history and additional supplemental material for this paper are available online. To view these fles, please visit the journal online (http://dx.doi.org/10.1136/ bmjopen-2021-052745). Received 26 April 2021 Accepted 08 October 2021 For numbered affliations see end of article. Correspondence to Professor Arianeb Mehrabi; arianeb.mehrabi@med.uni- heidelberg.de Protocol © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. ABSTRACT Introduction Total pancreatoduodenectomy (TP) is the standard surgical approach for treating extended pancreas tumours. If TP is performed with splenectomy, the left gastric vein (LGV) sometimes needs to be sacrifced for oncological or technical reasons, which can result in gastric venous congestion (GVC). GVC can lead to gastric venous infarction, which in turn causes gastric perforation with abdominal sepsis. To avoid gastric venous infarction, partial or total gastrectomy is usually performed if GVC occurs after TP. However, gastrectomy can be avoided by reconstructing the gastric venous outfow to overcome GVC and avoid gastric venous infarction. The current study aims to assess the role of gastric venous outfow reconstruction to prevent GVC after TP and avoid gastrectomy. Methods and analysis In the current single-centre observational pilot study, 20 patients will be assigned to study after intraoperative evaluation of gastric venous drainage after LGV resection during TP. During surgery, on- site evaluation by the surgeon, endoscopic examination, indocyanine green, gastric venous drainage fowmetry and spectral analysis will be performed. Postoperatively, patients will receive standard post-TP care and treatment. During hospitalisation, endoscopic examination with indocyanine green will be performed on the 1st, 3rd and 7th postoperative day to evaluate gastric ischaemia. Ischaemia markers will be evaluated daily after surgery. After discharge, patients will be followed-up for 90 days, during which mortality and morbidities will be recorded. The main endpoints of the study will include, rate of GVC, rate of gastric ischaemia, rate of postpancreatectomy gastrectomy, rate of reoperation, morbidity and mortality. Ethics and dissemination The study protocol has been reviewed and approved by the Ethics Committee of the University of Heidelberg. The results will be actively disseminated through peer-reviewed journals and conference presentations, and are expected in 2022. Trial registration number NCT04850430. INTRODUCTION Total pancreatoduodenectomy (TP) is the standard surgical approach for treating extended pancreas tumours. Patients under- going TP to treat malignant lesions often undergo splenectomy at the same time for oncological reasons, 1 2 which can disrupt venous drainage of the stomach. The stomach is drained via three major routes: (1) the distal stomach is drained via the right gastric and the right gastroepiploic vein, (2) the greater curvature is drained via the short gastric veins and the left gastroepiploic vein into the splenic vein and (3) the lesser curvature is drained via the left gastric vein (LGV). 3 4 When TP is performed together with splenectomy, the LGV sometimes has Strengths and limitations of this study ► This is the frst prospective study, which evaluates the effect of the gastric venous reconstruction on gastric venous congestions and surgical outcomes of the patients undergoing total pancreatectomy with splenectomy and additional left gastric vein resection. ► The complex intervention of gastric venous recon- struction will be carried out in a large scale of pa- tients for the frst time, whereas current reports in the literature include only case reports. ► This observational study will be carried out without randomisation or control group. ► Generalisability of the outcomes might be restricted to highly qualifed facilities and tertiary referral hos- pitals with high volume of pancreas surgeries. on April 14, 2022 by guest. 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