The ICAN research question is: What is the effectiveness of an intrathoracic compared to a cervical esophagogastric anastomosis after (hybrid) minimally invasive esophagectomy in terms of anastomotic leakage, morbidity, quality of life and costs?
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Anastomotic leakage requiring endoscopic, radiologic or surgical reintervention
Secondary outcome
Secondary outcome parameters (amongst others): quality of life, functional
morbidity, complications, organ failure, reintervention, length of stay,
mortality, and costs.
Background summary
Esophageal carcinoma is a complex disease process of increasing incidence that
exerts a social and financial burden on global
healthcare systems. Particularly, anastomotic leakage is an important
post-operative complication that results in major
morbidity, reoperation, delayed discharge, and psychological and financial
distress. It has been suggested that anastomotic
leakage, major morbidity, and therefore associated costs are lower after an
intrathoracic esophagogastric anastomosis as
compared to a cervical esophagogastric anastomosis. However, high quality
evidence is lacking.
Study objective
The ICAN research question is: What is the effectiveness of an intrathoracic
compared to a cervical esophagogastric
anastomosis after (hybrid) minimally invasive esophagectomy in terms of
anastomotic leakage, morbidity, quality of life and costs?
Study design
Open multicentre randomized controlled superiority trial
Intervention
(Hybrid) minimally invasive esophagectomy with an intrathoracic esophagogastric
anastomosis (intervention group) is compared to (hybrid) minimally invasive
esophagectomy with cervical esophagogastric anastomosis (control group)
Study burden and risks
One extra telefphone call or study visit preoperatively is required if the
surgeon decides to approach the patient after neoadjuvant therapy. All other
visits (5-9 weeks after surgery, 12-16 weeks after surgery, 22-30 weeks after
surgery, 48-56 weeks after surgery and 100-108 weeks after surgery) coincide
with normal postoperative follow-up visits and do not contribute to the
participant burden. QOL questionnaires (EuroQol 5D, EORTC- QLQ C30 and
EORTC-QLQ OG25) are filled in 6 times per patient (15 minutes to complete). The
Medical Consumption Questionnaire (MCQ) and Productivity Cost Questionnaire
(PCQ) are filled in 5 times per patient (25 minutes to complete). Other
follow-up or diagnostic procedures do not differ from regular practice.
Both a CA and ITA are currently accepted surgical techniques for reconstructing
continuity of the gastrointestinal tract after esophagectomy without convincing
evidence to prefer one technique over the other. Therefore, no additional risks
are associated with participation.
Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
- Age >=18 years.
- Histologically proven esophageal carcinoma below the carina or at the level
of the gastro-esophageal junction (Siewert 2).
- Resectable tumour (T1b-4a N0-3 M0).
- Mental, physical and geographical ability to undergo treatment and follow-up.
- Ability to provide written informed consent.
Exclusion criteria
- Previous major gastric or major thoracic surgery rendering (hybrid) minimally
invasive esophagectomy unfeasible).
- Secondary, prognosis determining malignancy.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL46843.091.14 |