Clinical trial · Observational
Gastric Microperfusion in Patients Undergoing Gastroesophageal Resections
Robotic Assisted Laparoscopy Versus Open Gastroesophageal Resection; Effects on the Mesenteric Traction Reflex and PGI2 Levels
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Gastroesophageal resection because of gastroesophageal junction (GEJ) adenocarcinoma is a massive surgical intervention. Currently, gastroesophageal cancer surgery is performed with upper laparotomy followed by thoracotomy at the Department of Surgical Gastroenterology, Rigshospitalet, Denmark. However, minimal invasive techniques (MIT), e.g. robotic assisted laparoscopy, is in the progress of being implemented in this field as they are hypothesized to be more beneficial for the patients, and in some aspects better than conventional laparoscopic surgery. The operative procedure is often complicated by low blood pressure (systolic blood pressure less than 90 mm Hg is experienced in more than 30 % of the patients) and is probably accompanied by a reduced splanchnic microcirculatory flow, leading to increased morbidity. Hypotension may be due to several factors, among them are epidural analgesia, mesentery traction reflex, and inflammatory and vasoactive hormones. Aim of the project The aim of the project is, through a series of sub-projects, to validate or invalidate the relationship between changes in the microcirculatory blood flow in the stomach and the systemic hemodynamic changes. Furthermore, the aim is to assess the changes in the microcirculatory blood flow as a consequence of the thoracic epidural anesthesia. In addition, the aim is to assess the hypothesis that the mesenteric traction reflex and changes in the PGI2 levels may influence systemic hemodynamic changes, and that robotic assisted MIT will attenuate the mesenteric traction reflex and changes in PGI2 compared to open surgery.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastroesophageal Junction Adenocarcinoma | Gastroesophageal Junction Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- open surgery
- description
- 25 patients undergoing open gastroesophageal resection
- label
- robotic-assissted surgery
- description
- 25 patients under-going robotic-assisted gastroesophageal surgery
Primary outcomes (1)
- measure
- the occurence of anastomotic leakage
- timeFrame
- 7 days post-operative
- description
- Anastomotic insufficiency is defined as leakage identified by: 1. X-ray of the esophagus with water-soluble contrast on the 7.th day after operation, or 2. CT-scan because of clinical signs (e.g. fever, pain), or 3. Gastroscopy in critically ill patients.
Secondary outcomes (1)
- measure
- The occurrence of Mesenteric Traction Reflex
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients diagnosed with adenocarcinoma in the gastroesophageal junction * Patients assumed to be resectable Exclusion Criteria: * lack of consent * non-adenocarcinomas
References
Publications (25)
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- BACKGROUNDBraga M, Vignali A, Zuliani W, Radaelli G, Gianotti L, Martani C, Toussoun G, Di Carlo V. Metabolic and functional results after laparoscopic colorectal surgery: a randomized, controlled trial. Dis Colon Rectum. 2002 Aug;45(8):1070-7. doi: 10.1007/s10350-004-6362-2. PMID 12195192
- BACKGROUNDGramigni E, Bracco D, Carli F. Epidural analgesia and postoperative orthostatic haemodynamic changes: observational study. Eur J Anaesthesiol. 2013 Jul;30(7):398-404. doi: 10.1097/EJA.0b013e32835b162c. PMID 23435278
- BACKGROUNDBriel JW, Tamhankar AP, Hagen JA, DeMeester SR, Johansson J, Choustoulakis E, Peters JH, Bremner CG, DeMeester TR. Prevalence and risk factors for ischemia, leak, and stricture of esophageal anastomosis: gastric pull-up versus colon interposition. J Am Coll Surg. 2004 Apr;198(4):536-41; discussion 541-2. doi: 10.1016/j.jamcollsurg.2003.11.026. PMID 15051003
- BACKGROUNDGomes M, Ramacciotti E, Miranda F Jr, Henriques AC, Fagundes DJ. Vascular flow of the gastric fundus after arterial devascularization: an experimental study. J Surg Res. 2009 Mar;152(1):128-34. doi: 10.1016/j.jss.2008.04.016. Epub 2008 May 7. PMID 18805545
- BACKGROUNDThomas DM, Langford RM, Russell RC, Le Quesne LP. The anatomical basis for gastric mobilization in total oesophagectomy. Br J Surg. 1979 Apr;66(4):230-3. doi: 10.1002/bjs.1800660404. PMID 454988
- BACKGROUNDPacheco PE, Hill SM, Henriques SM, Paulsen JK, Anderson RC. The novel use of intraoperative laser-induced fluorescence of indocyanine green tissue angiography for evaluation of the gastric conduit in esophageal reconstructive surgery. Am J Surg. 2013 Mar;205(3):349-52; discussion 352-3. doi: 10.1016/j.amjsurg.2012.11.005.