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Completed

NCT Number: NCT02432794

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

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.

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Key information

Conditions

Esophageal Anastomotic Leak

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leandre Farran Teixidor

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

About this study

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 to 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 blood perfusion after a period of time. Few studies, only case-reports, describe a decrease in the incidence of intrathoracic and cervical anastomotic leakage. May the delay phenomenon reduce the incidence of anastomotic intrathoracic leakage?. There aren't any prospective randomized controlled trials to answer this question.

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

We decided to conduct this trial as a pilot study due to the fact that the number of patients needed to achieve statistical significance was to high and would have taken almost 10 years. We established a recruitment period of 3 years, in wich we intend to include 60 patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients requiring a subtotal esophagectomy with en-bloc resection and an intrathoracic esophagogastrostomy for esophageal cancer
  • 18 or above years old
  • Acceptance and signing the full informed consent

Exclusion criteria

  • Absence of pancreatitis
  • Anatomic vascular alteration that contraindicate the embolization (congenital celiac trunk stenosis, presence of arcuate ligament,etc,..)
  • refuse to collaborate in the study

Treatment and study plan

delay phenomenon by arteriographic approach

Procedure

we improve the microvascularization of the gastric fundus occluding the right and left gastric artery, and splenic artery two weeks before surgery by arteriography

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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).

  2. 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

  3. major and minor morbidity

    Time frame: 90 days

    investigators will evaluate morbidity according to Clavien-Dindo classification

  4. postoperative mortality

    Time frame: during hospitalization and/or 30 days after surgery

  5. 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

  6. 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)

Sponsors and collaborators

Lead sponsor

Hospital Universitari de Bellvitge

Other

Registry information

Official study title

Prospective Randomized Clinical Trial on Delay Phenomenon Utility in Preventing Oesophagogastric Anastomotic Dehiscence After Ivor-Lewis Esophagectomy. Pilot Study.

Acronym: APIL_2013

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
May 4, 2015
Registry last updated
Aug 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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