Clinical Trial: Trial on Delay Phenomenon Utility in Preventing Anastomotic Leakage After an Esophagectomy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Prospective Randomized Clinical Trial on Delay Phenomenon Utility in Preventing Oesophagogastric Anastomotic Dehiscence After an Ivor-Lewis Esophagectomy

Brief Summary: This is a randomized clinical trial to clarify if the delay phenomenon could reduce the incidence of oesophagogastric dehiscence after an esophagectomy for esophageal cancer comparing an experimental group vs control group. The delay phenomenon will be performed by an arteriographic approach.

Detailed Summary:

Subtotal esophagectomy with tubular gastroplasty to upper mediastinum and esophagogastric anastomosis (Ivor-Lewis procedure) is a very complex surgical technique. It is performed in patients with infracarinal esophageal carcinoma and is associated with a high morbidity rate in specialized centers (up to 60% in some groups). One of the most important postoperative complications is the oesophagogastric anastomotic leakage which leads a high morbidity (mediastinitis, respiratory failure, pleural effusion) and mortality rate (up to 60% depending on the reports).

The most important cause of anastomotic leakage is the stomach's extreme sensitivity to ischemic injury. There are several experimental studies that have demonstrated that the delay phenomenon before the esophageal resection surgery aims to improve issue perfusion after a period of time. Few studies, only cases reports, describe a decrease of the incidence of intrathoracic and cervical anastomotic leakage. May the delay phenomenon reduce the incidence of anastomotic intrathoracic leakage?. There aren't prospective randomized controlled trials to answer this question.

For this reason the investigators propose to perform a prospective randomized controlled trial in patients underwent on a subtotal esophagectomy (Ivor-Lewis procedure), comparing two groups: one of them will be subjected a delay phenomenon by arteriographic procedure before esophageal resection surgery, and the other one will be operated directly, to demonstrate if the delay phenomenon can reduce the incidence of anastomotic esophagogastric leakage.


Sponsor: Hospital Universitari de Bellvitge

Current Primary Outcome: Anastomotic leakage [ Time Frame: 7 days ]

investigators will consider anastomotic dehiscence the presence of one or more of the following conditions: radiologic confirmation by water-soluble contrast study (gastrografin administered orally) or thoracoabdominal Tc with oral contrast of dehiscence of oesophagogastric anastomosis or the stapler end of the gastroplasty.

When the clinical conditions of patient don't allow a Rx control investigators will consider an anastomotic leakage in these conditions:

Thoracic drain output of oesophagogastric content with amylase > 40 ukAT/L, confirmation of anastomotic dehiscence by the surgeon during a reintervention, endoscopic confirmation of anastomotic leakage of the stapled end of the plasty and methylene blue output after oral administration (100 ml of water with 10ml of methylene blue)



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • plasty ischemia [ Time Frame: 7 days ]

    investigators will consider plasty ischemia when one or more of the following criteria is present:

    • endoscopic evidence of gastric mucosa ischemia
    • evidence of low captation of the plasty in a thoracoabdominal CT with endovenous contrast that requires a reintervention.
    • intraoperative mortality (during hospitalization and/or 30 days after surgery).
  • hospital stay [ Time Frame: 90 days ]
    investigators will consider since the day of the surgery until the day the patient will be discharged from the hospital
  • major and minor morbidity [ Time Frame: 90 days ]
    investigators will evaluate morbidity according to Clavien-Dindo classification
  • postoperative mortality [ Time Frame: during hospitalization and/or 30 days after surgery ]
  • post-embolization morbidity [ Time Frame: 30 days ]

    investigators will consider post-embolization morbidity the following situations:

    • abdominal pain with EVA>3 (evaluated by EVA classification )
    • pancreatitis diagnosed by abdominal pain and amylase > 5 uKat/L or by CT.
    • abscess, pseudocyst diagnosed by CT or during oesophageal surgery
    • spleen ischemia diagnosed by CT or abdominal ultrasound and needs some treatment
    • liver ischemia diagnosed by Ct or abdominal ultrasound
    • bleeding or artery dissection diagnosed during the embolization and needs some treatment
    • arterial pseudoaneurism diagnosed during the embolization or by CT
  • anastomotic stricture [ Time Frame: 6 months ]
    investigators will consider anastomotic stricture when they observe a reduction of anastomotic diameter by oral contrast Rx and needs some treatment (endoscopic dilation or reintervention)


Original Secondary Outcome: Same as current

Information By: Hospital Universitari de Bellvitge

Dates:
Date Received: April 21, 2015
Date Started: May 2015
Date Completion: April 2018
Last Updated: March 5, 2017
Last Verified: August 2016