Gastric Microperfusion in Patients Undergoing Gastroesophageal Resections

NCT02077673 | Completed DMC

• 2 other identifiers: H-2-2013-10130-1152
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Gastroesophageal Junction Adenocarcinoma; Surgery

Keywords

GEJ-cancer; surgery; gastroesophageal resection; gastroesophageal anastomosis; anastomotic leakage

Outcome Measures

Primary Outcomes (1)

• the occurence of anastomotic leakage

  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.

  7 days post-operative

Secondary Outcomes (1)

• The occurrence of Mesenteric Traction Reflex

  the initial 60 minutes of surgery

Study Arms (2)

open surgery

25 patients undergoing open gastroesophageal resection

robotic-assissted surgery

25 patients under-going robotic-assisted gastroesophageal surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients will be recruited at; The Department of Surgical Gastroenterology, Rigshospitalet, Denmark

You may qualify if:

• Patients diagnosed with adenocarcinoma in the gastroesophageal junction
• Patients assumed to be resectable

You may not qualify if:

• lack of consent
• non-adenocarcinomas

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Department of Surgical Gastroenterology, Rigshospitalet

Copenhagen Ø, 2100, Denmark

Location

Related Publications (25)

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  PMID: 28159014 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum Tissue

MeSH Terms

Conditions

Anastomotic Leak

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lars Bo Svendsen, prof., MD

  Rigshospitalet, Denmark

  STUDY DIRECTOR

• Michael P Achiam, MD, PhD

  Rigshospitalet, Denmark

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 12, 2014
• First Posted: March 4, 2014
• Study Start: December 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: April 1, 2015
• Last Updated: May 5, 2015

Record last verified: 2015-05

Locations

DK (1)