Mesenteric Traction Syndrome During Upper Gastrointestinal Surgery

NCT02507414 | Completed

• 1 other identifier: H-3-2014-021
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

It is the hypothesis of this project that the Mesenteric Traction Syndrome (MTS) is a common event during upper gastrointestinal cancer surgery (UGC surgery) and that the induction of the syndrome is an important factor in provoking further peri- and postoperative complications and in worsening the surgical stress response (SSR). The characteristics of MTS is hypotension, tachycardia, and flushing. In order to uncover the role of MTS in cancer surgery and the effects on the oncological patients, the aim of the project is: 1\. To characterize MTS in patients undergoing three common forms of UGC surgery using a new objective methodology and by recording biomarkers suspected of playing a role in the pathophysiology of MTS and postoperative complication development. Three different interventions will be examined during this prospective trial:

1. 1.Continuous measurement of microcirculation on the forehead using Laser Speckle Contrast Imaging during surgery.
2. 2.Analyses of plasma samples obtained pre-, intra-, and one day postoperatively.
3. 3.Continuous measurements of haemodynamic variables during surgery.

Conditions

Gastrointestinal Neoplasms; Mesenteric Traction Syndrome

Keywords

Mesenteric Traction Syndrome; Upper gastrointestinal cancer surgery

Outcome Measures

Primary Outcomes (1)

• Relative changes in plasma-hormone concentrations (pro-ANP, PGF2, GLP-1, ACTH, cortisone, adrenaline, IL-1, IL-6, TNF-alfa and CRP (stress hormones)) from baseline.

  A: the day before the surgical procedure B: After induction of anaesthesia (baseline) C: 5 min intraoperatively D: 15 min intraoperatively E: 30 min intraoperatively F: 60 min intraoperatively G: 90 min intraoperatively H: 120 min intraoperatively I: 180 min intraoperatively J: Procedure ending K: 5 min after head down tilt (1) L: One hour after surgery M: 5 min after head down tilt (2) N: 18 hours postoperatively O: 5 min after head down tilt (3)

  15 blood samples obtained pre-, intra-, and 18 hours postoperatively

Secondary Outcomes (8)

• Postoperative complications

  Participants will be followed during the hospital stay, with an expected average of ten days

• Relative changes in heart rate from baseline measured in beats per minute

  Continuous measurements intra- and postoperatively.

• Relative changes in microcirculation from baseline during surgery measured in flux-units

  A continuous measurement starting one minute prior to the surgical procedure and terminates after 60 minutes.

• 30-days and 90-days mortality

  30-days and 90-days mortality

• Length of stay

  Expected time frame of 10 days in average.

Study Arms (1)

Group 1

EXPERIMENTAL

Patients under going Whipple's procedure, gastric resection and liver resection (n=75). Interventions: Blood samples obtained pre-, intra-, and one day postoperatively (n=15). Measurements of microcirculation using LSCI from procedure start and up to 60 min during surgery. Head down tilt of 20 degrees at three time points.

Other: Blood samples; Other: Measurement of microcirculation; Other: Head down tilt

Interventions

Blood samples OTHER

15 arterial blood samples (pre-, intra- and one day postoperatively); no more than 180ml in total over two days.

Group 1

Measurement of microcirculation OTHER

Measurement of microcirculation with Laser Speckle Contrast Imaging (non-touch setup with no side effects); continuous measurement of the microvascular blood flow on the forehead up to 60 minutes starting one minute before the surgical procedure.

Also known as: LSCI

Group 1

Head down tilt OTHER

At three different time points the participants will be head down tilted in 20 degrees. End of surgery (A) One hour postoperatively (B) 18 hours postoperatively (C)

Group 1

Eligibility Criteria

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

You may qualify if:

• \- patients under going either whipple's procedure, liver resection, or gastric resection.

You may not qualify if:

• Robotic assisted procedures
• Lack of informed consent

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Danish Cancer Society: collaborator

Related Publications (9)

• Rizk NP, Bach PB, Schrag D, Bains MS, Turnbull AD, Karpeh M, Brennan MF, Rusch VW. The impact of complications on outcomes after resection for esophageal and gastroesophageal junction carcinoma. J Am Coll Surg. 2004 Jan;198(1):42-50. doi: 10.1016/j.jamcollsurg.2003.08.007.

  PMID: 14698310 BACKGROUND

• Biere SS, van Berge Henegouwen MI, Maas KW, Bonavina L, Rosman C, Garcia JR, Gisbertz SS, Klinkenbijl JH, Hollmann MW, de Lange ES, Bonjer HJ, van der Peet DL, Cuesta MA. Minimally invasive versus open oesophagectomy for patients with oesophageal cancer: a multicentre, open-label, randomised controlled trial. Lancet. 2012 May 19;379(9829):1887-92. doi: 10.1016/S0140-6736(12)60516-9. Epub 2012 May 1.

  PMID: 22552194 BACKGROUND

• Giannoudis PV, Dinopoulos H, Chalidis B, Hall GM. Surgical stress response. Injury. 2006 Dec;37 Suppl 5:S3-9. doi: 10.1016/S0020-1383(07)70005-0.

  PMID: 17338909 BACKGROUND

• Kehlet H. The stress response to surgery: release mechanisms and the modifying effect of pain relief. Acta Chir Scand Suppl. 1989;550:22-8.

  PMID: 2652970 BACKGROUND

• Pham TH, Perry KA, Enestvedt CK, Gareau D, Dolan JP, Sheppard BC, Jacques SL, Hunter JG. Decreased conduit perfusion measured by spectroscopy is associated with anastomotic complications. Ann Thorac Surg. 2011 Feb;91(2):380-5. doi: 10.1016/j.athoracsur.2010.10.006.

  PMID: 21256274 BACKGROUND

• Avgerinos DV, Theoharides TC. Mesenteric traction syndrome or gut in distress. Int J Immunopathol Pharmacol. 2005 Apr-Jun;18(2):195-9. doi: 10.1177/039463200501800202.

  PMID: 15888243 BACKGROUND

• Seltzer JL, Ritter DE, Starsnic MA, Marr AT. The hemodynamic response to traction on the abdominal mesentery. Anesthesiology. 1985 Jul;63(1):96-9. doi: 10.1097/00000542-198507000-00015. No abstract available.

  PMID: 4014775 BACKGROUND

• Mythen MG, Webb AR. Intra-operative gut mucosal hypoperfusion is associated with increased post-operative complications and cost. Intensive Care Med. 1994;20(2):99-104. doi: 10.1007/BF01707662.

  PMID: 8201106 BACKGROUND

• Ceppa EP, Fuh KC, Bulkley GB. Mesenteric hemodynamic response to circulatory shock. Curr Opin Crit Care. 2003 Apr;9(2):127-32. doi: 10.1097/00075198-200304000-00008.

  PMID: 12657975 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

Blood Specimen Collection; Head-Down Tilt

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 13, 2015
• First Posted: July 24, 2015
• Study Start: August 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 5, 2016

Record last verified: 2016-10