Clinical trial · Interventional

Mesenteric Traction Syndrome During Upper Gastrointestinal Surgery

Characterization of the Mesenteric Traction Syndrome During Upper Gastrointestinal Surgery for Malignant Disease

NCT02507414CI-TRIAL-00024151completedN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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. Continuous measurement of microcirculation on the forehead using Laser Speckle Contrast Imaging during surgery. 2. Analyses of plasma samples obtained pre-, intra-, and one day postoperatively. 3. Continuous measurements of haemodynamic variables during 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
Gastrointestinal Neoplasms	Digestive System Neoplasm	ALIAS	0.90
Mesenteric Traction Syndrome	—	UNRESOLVED	—

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
Blood samples	Other	—	UNRESOLVED
Head down tilt	Other	—	UNRESOLVED
Measurement of microcirculation	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Group 1
description
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.
interventionNames
1. Other: Blood samples
2. Other: Measurement of microcirculation
3. Other: Head down tilt

Primary outcomes (1)

measure
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.
timeFrame
15 blood samples obtained pre-, intra-, and 18 hours postoperatively
description
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)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

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

Exclusion Criteria:

* Robotic assisted procedures
* Lack of informed consent

References

Publications (9)

BACKGROUNDRizk 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
BACKGROUNDBiere 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
BACKGROUNDGiannoudis 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
BACKGROUNDKehlet 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
BACKGROUNDPham 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
BACKGROUNDAvgerinos 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
BACKGROUNDSeltzer 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.