Trial on Delay Phenomenon Utility in Preventing Anastomotic Leakage After an Esophagectomy (APIL_2013)

August 19, 2019 updated by: Leandre Farran Teixidor, Hospital Universitari de Bellvitge

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • L'Hospitalet De Llobregat, Barcelona, Spain, 08907
        • Leandre Farran Teixidor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: delay phenomenon by arteriography

intervention: delay phenomenon by arteriography. Patients who will be subjected a delay phenomenon by arteriographic procedure before esophageal resection surgery minimum 14 days before surgery.

An angiogram of the celiac trunk is performed through a femoral access before and after the embolization. A 4-5 Fr Simmons or Cobra catheter is used for the catheterization and embolization of the left gastric artery, and 0.035-inch platinum coils are proximally placed from the main trunk in the splenic artery. When accessory left gastric arteries are present, they are catheterized and embolized as well. The right gastric artery catheterization is realized by a 4-5 Fr catheter and coils or microcoils are proximally placed in the artery as well.
Procedure: delay phenomenon by arteriographic approach
we improve the microvascularization of the gastric fundus occluding the right and left gastric artery, and splenic artery two weeks before surgery by arteriography
NO_INTERVENTION: control group
Patients who will be operated directly without gastric ischemic conditioning. The investigators don't performed any arteriography before the esophageal surgical resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
7 days
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
90 days
major and minor morbidity
Time Frame: 90 days
investigators will evaluate morbidity according to Clavien-Dindo classification
90 days
postoperative mortality
Time Frame: during hospitalization and/or 30 days after surgery
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
30 days
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)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari de Bellvitge

Investigators

  • Principal Investigator: Leandre F Teixidor, Ph D, MD, Bellvitge University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (ACTUAL)

May 1, 2019

Study Completion (ACTUAL)

June 1, 2019

Study Registration Dates

First Submitted

April 21, 2015

First Submitted That Met QC Criteria

May 1, 2015

First Posted (ESTIMATE)

May 4, 2015

Study Record Updates

Last Update Posted (ACTUAL)

August 20, 2019

Last Update Submitted That Met QC Criteria

August 19, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APIL_2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Esophageal Anastomotic Leak

Clinical Trials on delay phenomenon by arteriographic approach

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe