Open Versus Laparoscopically-assisted Esophagectomy for Cancer

Esophageal Cancer Clinical Trial

Official title:

Open vs Laparoscopically-assisted Esophagectomy for Cancer: A Multicentric Phase III Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00937456
• Other study ID #: 2008_24/0904
• Secondary ID: PHRC 2008/190720
• Status: Completed
• Phase: N/A
• Start date: October 7, 2009
• Est. completion date: October 1, 2015

Study information

• Verified date: June 2018
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare laparoscopically-assisted gastric mobilization versus open gastric mobilization in Ivor-Lewis esophagectomy for esophageal cancer, with open thoracic approach in the 2 arms.

Description:

Open Versus Laparoscopically-assisted Esophagectomy for Cancer

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: October 1, 2015
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Squamous cell or adenocarcinoma of the thoracic esophagus T1, T2, T3, N0-N1, M0, before any treatment

• Middle or lower third esophageal carcinoma, junctional tumor Siewert type I

• Patients who underwent or not neoadjuvant chemotherapy or chemoradiation

• Tumor deemed to be resectable in a curative intent at the preoperative setting

• Age less than 75 years old, OMS status 0, 1 or 2

• Patient who can undergo one or the other surgical modality

• Written informed consent form

• Possible follow-up

Exclusion Criteria:

1. General criteria: PO2 = 60 mmHg; PCO2 > 45 mmHg; FEV = 1000 ml/sec

• Hepatic cirrhosis

• Recent myocardial infarction (in the previous 6 months) or progressive coronary disease

• Distal arteritis (Leriche-Fontaine stage II upwards)

• Concomitant cancer, other than subcarinal esophageal cancer

2. Disease-related factors

• Invasion of subclavicular lymph nodes in a clinical examination or on biospy

• Lymph nodes near the origin of the celiac artery with a diameter = 1 cm on CT or that appear to be suspect on endoscopic ultrasound (to differentiate them from the paracardial or left gastric lymph nodes, which does not constitute an exclusion criterion)

• Recurrent nerve palsy

• Evidence of extension to the tracheobronchial tree

• Signs of mediastinal invasion (vertebral contact, aortic contact = 90°, or invasion of nonresectable neighboring organs such as the aorta, trachea, main bronchi, etc.)

• Distant metastasis

3. Laparoscopy-related factors

• Patient presenting a general contraindication to laparoscopy

• A history of median or subcostal laparotomy

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Procedure:
• Laparoscopically-assisted esophagectomy
To compare during the abdominal approach the laparoscopic route to the open route for gastric mobilization. Thoracic approach will be the same between the 2 arms through thoracotomy with extended two field lymphadenectomy

Locations

Country	Name	City	State
France	Hopital Du Haut Leveque	Bordeaux
France	Hopital Ambroise Pare Ap-Hp	Boulogne Billancourt
France	Hotel Dieu	Clermont Ferrand
France	Hopital Louis Mourier	Colombes
France	Hopital de La Croix Rousse	Lyon
France	Hopital St Marguerite Ap-Hm	Marseille
France	Hopital St Louis Ap-Hp	Paris
France	Institut Mutualiste Montsouris	Paris
France	Hopitalpontchaillou	Rennes
France	Hopitaux Universitaires de Strasbourg	Strasbourg
France	Hopital Purpan	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To decrease postoperative major 30-days morbidity from 45% in the open arm to 25% in the laparoscopically-assisted arm.		30 days
Secondary	overall morbidity		30 days
Secondary	disease free survival		2 years
Secondary	overall survival		2 years
Secondary	quality of life		2 years
Secondary	economical interest of the surgical technique apprehended through a hospital point of view		6 months