SHARE study: A randomized controlled trial comparing a semimechanical with a hand sewn cervical anastomosis after esophagectomy with gastric tube reconstruction for cancer.

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 compared 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.

A novel 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 semi-mechanical side-to-side anastomosis is
associated with low anastomotic leak rates (5%). Also the percentage of patients with stenosis of the anastomosis is more favourable (10-20%). However, no randomized trial has been conducted which compared this novel semi-mechanical technique with standard techniques.

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 the semi-mechanical with the hand sewn cervical anastomosis after esophagectomy with gastric tube reconstruction for cancer.

Sugarahara score at 3,6,9 and 12 months after surgery.

QoL EORTC OES 18 en OES 30 preoperative and at 3,6,9 and 12 months postoperative.

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 displacement 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 Vshaped 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.”