Semi-mechanical versus hand sewn cervical anastomosis after esophagectomy with gastric tube reconstruction for esophageal cancer; the SHARE study

Failure of the anastomosis between the esophagus and stomach tube after radical
esophagectomy occurs in about 20% of patients and contributes to the already
high morbidity (40-60%) and hospital mortality (3-6%). Anastomotic leakage
delays oral intake and prolongs jejunal feeding. It prolongs hospital stay,
leads to extra interventions, resulting in increased costs in- and outside the
hospital. Anastomotic leakage also leads to a high chance of stenoses of the
anastomosis and to 50% of patients need multiple, endoscopicaly guided
dilatations. The optimal technique of joining the esophagus to the stomach tube
in the neck is not known due to a lack of randomized trials. Recently we
randomised the handsewn end-to-end technique with the end-to-side technique.
The end-to-end technique was associated with less leakage (22%) but higher
rates of stenosis (40%) were seen.

Recently a semi-mechanical side-to-side anastomosis has been described by
Collard. With this technique a wide anastomosis is created with the use of a
mechanical stapler device after which the resulting opening is closed by a
running suture. The Department of Thoracic Surgery in Leuven, Belgium has
popularized this technique.

Retrospective studies suggest that the percentage of anastomotic leakage is low
and stenosis is low (5% and 10-20% respectively). It is hypothesised that a
semi-mechanical side-to-side anastomosis is associated with lower leaks rates
and a lower chance of stenosis. However, no randomized trial has been
conducted which compared this novel semi mechanical technique with standard
techniques.

A small pilot is performed in our center by our surgeons, 20 patients received
the new semi-mechanical anastomosis and were followed for four months. Only one
leak was found.

The aim of this study is to compare the semi-mechanical anastomosis and the
hand sewn end-to-end anastomosis after esophageal resection and stomach tube
reconstruction in patients with esophageal carcinoma.

The primary objective of this study is to compare a semi-mechanical with a hand
sewn cervical anastomosis after esophagectomy with gastric tube reconstruction
for cancer.

This trial is designed as a single-center patient-blinded, randomised
controlled trial. There are two groups, each with 90 patients. To include 90
patients per group, with a mean of 75 esophagectomies per year, the estimated
duration of this study will be 3-4 years. Follow up till primary endpoint is 30
days after surgery, but secondary endpoints are until 1 year after surgery,
therefore data will be collected in 4-5 years.

Protocol oral intake: From day 1-6 posteropatively, patients are only allowed
to take sips of water. On day 7 fluids and semisolid food is allowed. In
between day 8 and 10 normal oral intake is continued. Any deviation of this
protocol is prohibited, unless there is medical condition which requires
prolonged denied oral intake, such as clinical suspicion of leakage.

End-to-end anastomosis: After complete mobilisation of the esophagus the
cervical esophagus is transacted at 4 to 5 cm below the upper esophageal
sphincter. A 3 cm wide stomach tube is created and the stomach tube is
transported by the pre-vertebral route to the neck. A hand-layed single layer
continuous esophagal gastrostomy is created with PDS 3/0.

Semi mechanical anastomosis: After complete mobilisation of the esophagus the
cervical esophagus is transacted 10 cm below the upper esophageal sphincter in
order to create a side-to-side semi mechanical anastomosis as described by
Collard; *In the terminalized semimechanical side-to-side suture technique,
once the cervical esophagus has been transected and the stomach pulled up to
the neck, a small incision is made at the top of the gastric transplant. The
posterior wall of the esophageal stump and that of the fundus are placed side
by side. The two forks of an stapler are placed across the two opposing walls
with the anvil in the gastric lumen and the cartridge of staples in the
esophageal lumen. After approximation of the two forks, the trigger of the
stapler is squeezed to allow forward dis- placement of the knife and the
delivery of three rows of staples on each side. After the two forks have been
separated, the stapler is removed and the two stapled wound edges retract
laterally on the action of the intra- mural musculature. The medial slit thus
becomes a V-shaped opening between the two lumina. The two posterior walls
realign themselves by exerting gentle downward traction on the transplant. The
anterior walls are sutured to each other using a single-layer running suture
technique similar to that used in manual anastomoses.*

Case record forms: In the post operative phase at the daily rounds at the ICU
and the surgical ward a standard checklist is used by the attending surgeon,
the specialist nurse practitioner or the research fellow to collect data.

The quality of life evaluations: The 5 quality of life of life evaluations are
scheduled preoperatively and at 3, 6, 9 and 12 months after operation.

As the sensitivity and specificity of a contrast swallow, a computer tomography
with oral contract intake or endoscopy to detect an anastomotic leakage is
rather low, no post-operative routine control of the anastomosis is performed.
Suspecting a clinical or non-clinical leak, the attending surgeon decides to
remain conservative or to choose for one of the above-mentioned options.

There is no risk associated with participation in comparison to patients who do
not participate in our trial. The burden is that we ask patients to complete a
Quality of Life questionnaire 5 times within one year (preoperative and at 3,
6, 9 and 12 months after surgery).