J Gastrointest Surg DOI 10.1007/s11605-014-2478-4

HOW I DO IT

Proximal Anastomosis Using the OrVil™ Circular Stapler in Major Upper Gastrointestinal Surgery Benjamin C. Knight & Samuel J. Rice & Peter G. Devitt & Andrew Lord & Philip A. Game & Sarah K. Thompson

Received: 3 December 2013 / Accepted: 28 January 2014 # 2014 The Society for Surgery of the Alimentary Tract

Abstract Anastomoses in major upper gastrointestinal surgery can be technically demanding, especially handsewn anastomoses traversing the diaphragmatic hiatus. The OrVil™ stapler is a unique circular stapler that allows rapid creation of various upper gastrointestinal anastomoses in technically challenging circumstances, particularly if additional proximal clearance is desirable. Little is reported in the literature regarding its outcomes and complication rates. In this ‘How I do It’ article, we describe our technique and experience with the OrVil™ in major upper gastrointestinal surgery. Keywords OrVil™ circular stapler . Oesophagectomy . Gastrectomy . Oesophageal cancer . Gastric cancer

Introduction There are many described techniques for oesophagogastric and oesophagojejunal anastomoses after oesophageal or gastric cancer resection. Techniques include handsewn and stapled anastomoses (circular or linear) in both open and minimally invasive approaches. These anastomoses can be technically challenging especially in patients with central obesity, long bulky tumours, and proximal gastric tumours with oesophageal extension. Handsewn anastomoses of the mid to lower third of the oesophagus (following total gastrectomy) are often hampered by poor surgical exposure and imprecise suture placement, which may lead to anastomotic leak. There is still much debate regarding the ideal technique, but no approach has been demonstrated as superior.1,2 Recently, a variety of techniques have been described in an attempt to improve the placement of the anvil for circular B. C. Knight : S. J. Rice : P. G. Devitt : P. A. Game : S. K. Thompson (*) Discipline of Surgery, University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia e-mail: [email protected] A. Lord Department of Surgery, The Queen Elizabeth Hospital, Woodville South, South Australia, Australia

double-stapled anastomoses.3–6 In both oesophagectomy and total gastrectomy, access to and working length of the oesophageal stump can be limited, particularly for proximal tumours. An important advantage of the OrVil™ (Covidien, Mansfield, MA) system is that it does not require a purse string suture to secure the anvil. This makes for a technically easier open and minimally invasive procedure and enables a more proximal anastomosis to ensure tumour-free resection margins. There is little published in the literature regarding the best technique for OrVil™ insertion/deployment, its outcomes, and potential pitfalls.7,8 We describe our technique of OrVil™ placement in Ivor Lewis oesophagectomy and total gastrectomy over the last 4.5 years.

Technique of OrVil™ Circular Stapler Insertion Preparation for Surgery Preoperative clinical staging included upper gastrointestinal endoscopy, computed tomography scans (chest, abdomen, and pelvis), positron emission tomography (PET) scans, endoscopic ultrasonography (if minimal stricturing), and diagnostic laparoscopy (for junctional or gastric tumours). All patients staged as T2 disease or greater were offered neoadjuvant therapy according to protocol.9 Patients with a gastric cancer underwent 3 cycles of MAGIC chemotherapy,9 and those with oesophageal cancer received 2 cycles of cisplatin (80 mg/m2 on day 1) and 5-FU (800 mg/m2 continuous

J Gastrointest Surg

infusion for 5 days) during weeks 1 and 5 plus 25 fractions of radiotherapy (over 5 weeks) to a total of 40–45 Gy. Patients underwent surgical resection 4 to 6 weeks after completion of neoadjuvant therapy. OrVil™ Circular Stapler The OrVil™ device consists of a pretilted circular anvil head attached via the centre rod to a 90-cm polyvinyl chloride (PVC) orogastric tube. The tube is attached to the centre rod by a single braided suture. When used with the EEA XL stapler, it creates a circular anastomosis comprising a double-staggered row of titanium staples (Fig. 1). Anvil Insertion and Deployment Our technique for both Ivor Lewis oesophagectomy (using a two-surgeon synchronous approach) and total gastrectomy have been described elsewhere.10 Once the surgeon is ready to divide the oesophagus proximally, the following steps are taken. First and foremost, the surgeon must ensure that no indwelling catheters are present in the oesophagus such as nasogastric tubes and nasoenteric temperature probes. Second, mobilize the oesophagus 1 cm above the intended point of transection to allow the anvil to sit comfortably on the oesophageal stump. Third, refrain from attaching stay sutures to the oesophagus to prevent retraction up into the mediastinum. These sutures are not necessary and may damage the oesophagus. The oesophagus is divided with a linear stapler; we use a TA30 or TA45 (Covidien, Mansfield, MA) with a 4.8-mm green staple load. The anesthesiologist inserts the OrVil™ per oral. We prefer to use the 25-mm EEA OrVil™ as the stoma created with the 21-mm OrVil™ is often too small. Under laryngoscopic/direct vision, the PVC orogastric tubing is lubricated and inserted, ensuring the black line of the orogastric tube remains posterior. This orientation is essential to allow smooth passage of the anvil through the pharynx and oesophagus (Fig. 2). The

Fig. 1 OrVil™ anvil. The anvil is in the pre-engaged tilted position with PVC orogastric tube attached (bottom image)

Fig. 2 Insertion of the OrVil™ anvil and orogastric tube per oral. Under laryngoscopic/direct vision, the PVC orogastric tubing is lubricated and inserted, ensuring the black line of the orogastric tube remains posterior. This orientation is essential to allow smooth passage of the anvil through the pharynx and oesophagus

orogastric tube is advanced, and the surgeon watches carefully to note the reappearance of the oesophagus into view (Fig. 3). Once this occurs, the surgeon helps position the tip of the tubing centrally over the anterior staple line of the oesophageal stump. Diathermy is then used to open the oesophagus over the tip of the tube tip. The tube is grasped using a haemostat and gently pulled down out of the distal end of the oesophagus until the anvil head reaches the mouth. The anvil is thoroughly lubricated, and the anaesthesiologist’s assistant performs a jaw thrust manoeuvre and straightens the patient’s neck to ensure easy passage of the anvil over the glottis. The surgeon slowly pulls the orogastric tube as the anesthesiologist guides the anvil over the back of the tongue and into the pharynx. Resistance is often felt at two distinct points, as the anvil crosses the upper pharyngeal sphincter and as it descends past the endotracheal tube cuff. Gentle sustained traction normally overcomes both sticking points. Added jaw thrust and slight deflation of the cuff may also help. The anvil is pulled through until it is sitting on the oesophageal stump. One limb of the suture attached to the anvil can now be cut

Fig. 3 The orogastric tube is advanced ensuring the black line of the orogastric tube remains in the posterior orientation

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Fig. 4 The OrVil™ anvil is pulled through a small oesophagotomy in the oesophageal stump. One limb of the anchoring suture to the anvil is cut with a scalpel. Cutting the suture allows the PVC tube to detach and the anvil to flip 90° into the engaged position. Gentle traction on the PVC tube whilst supporting the OrVil™ centre rod allows the tubing to detach. An EEA XL circular stapler is used to connect with the OrVil™. An audible click should be heard and felt as the prongs on the anvil centre rod engage with the stapler pin at the orange marker

using a scalpel and removed. We suggest cutting the suture close to the head of anvil as this minimizes the risk of suture material remaining behind in the anvil. One hand supports the anvil centre rod whilst the other provides gentle counter traction on the PVC tube. The tubing will now detach from the anvil with ease and can be discarded. An EEA XL (Covidien, Mansfield, MA) circular stapler is used to connect with the OrVil™. Note that the EEA XL will not fit the OrVil™ device. The EEA XL is well-lubricated and inserted into the opened pylorus for oesophagectomy or through the Roux end of the opened staple line of jejunum for gastrectomy. The stapler is opened to allow the spike to perforate the antimesenteric wall of the desired conduit. Ensuring there is no twist or tension on the conduit, the anvil is engaged to the circular stapler (Fig. 4). An audible click should be heard and felt as the prongs on the anvil centre rod engage with the stapler pin at the orange marker. The EEA XL and OrVil™ anvil are opposed until the tissue tension marker on the EEA XL lies within the ‘green zone’. Occasionally, the EEA XL stapler pin does not correctly engage with the OrVil anvil centre rod and often disengages when retracting the EEA XL stapler pin. Care should be taken to ensure the EEA XL pin is fully deployed and not retracting during docking with the OrVil centre rod (see Table 1 for solution). The surgeon should be reassured that once the EEA XL pin has retracted passed the orange marker with the OrVil engaged, it cannot then disengage. It should be left in this position for at least 15 s for tissue compression, the safety catch release and then fired resulting

Table 1 Potential pitfalls of proximal anastomoses with the OrVil™ circular stapler Problem

Solution

Inclusion of temperature probe/nasogastric tube during oesophageal resection with linear stapler OrVil™ stuck on oropharynx

Open staple line and remove. Buttress staple line with purse string suture and deliver anvil per oral Ensure anvil is lubricated Ensure anvil is in correct orientation

OrVil™ stuck in upper oesophagus

Anvil slips back into oesophagus Anvil will not engage with staple gun

Staple misfire Incomplete donuts

Jaw thrust and head tilt with sustained gentle traction on orogastric tube Ensure correction orientation Deflate endotracheal tube cuff temporarily whilst surgeon applies gentle traction to orogastric tube Insert 52-French bougie or endoscope to push anvil back into view (consider reinforcing with purse string suture if enterotomy enlarged during retrieval) Ensure correct gun is being used (EEA XL) Ensure pin of EEA XL and anvil if absolutely parallel Ensure if pin on EEA XL is not retracting during docking of anvil to pin. Remedy by assistant holding EEA XL rotation knob to ensure pin fully deployed Ensure that shaft of anvil is not being deformed by a grasper/haemostat Ensure that no digital pressure is being placed behind anvil head. This will cause the anvil head to tilt into the locked position prematurely, and it will not engage with the EEA XL Abort and perform standard handsewn anastomosis Reinforce staple line with interrupted sutures/consider insertion of feeding jejunostomy

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in an end-to-side anastomosis. The stapler is opened with four half anticlockwise turns, and the donuts are checked to ensure that they are complete (see Table 1). We do not routinely test the integrity of the anastomosis, but we will buttress the anastomosis with four or six mattress sutures if the donuts are incomplete.

Comment All patients undergoing oesophageal or gastric resection between September 2008 and April 2013 were identified from a prospectively maintained surgical database. All operations were performed or closely supervised by one of four surgeons (PGD, PAG, AL, and SKT). We identified 67 patients in which the OrVil™ circular stapler was used to create an anastomosis. Forty oesophagogastric anastomoses were performed following Ivor Lewis oesophagectomy, and 27 oesophagojejunal anastomoses were performed following total gastrectomy. The median patient age was 66 years. Median follow-up was 13.6 months. Median proximal clearance margin was 44 mm. Neoadjuvant treatment was successfully completed in 35 patients (52 %). There were no in-hospital deaths. The OrVil™ can be used for a variety of oesophageal and gastric anastomoses and provides a reliable and reproducible anastomosis in technically challenging situations. It is ideally suited for the minimally invasive approach but has equal applicability in open oesophagogastric surgery. It is particularly useful when added proximal tumour clearance is required and exposure for a handsewn anastomosis is suboptimal. Many factors affect the integrity of a surgical anastomosis: smoking, body mass index, diabetes, peripheral vascular disease, neoadjuvant therapy, blood supply to the anastomosis, and tension. Meta-analysis has shown no difference in anastomotic leak rate between handsewn and stapled oesophagogastric anastomoses.11 Used correctly, the anastomosis formed using the OrVil™ has a low anastomotic leak rate. One patient (1.9 %) in our series incurred an anastomotic leak which required surgical correction and this is similar to published reports.12 The 25-mm anvil produces a widely patent stoma with a low rate of stricture formation, seven patients (10.5 %) in our series. All strictures were successfully dilated with Savary-Gilliard dilators. Recent studies have shown no difference in stricture rate between 25-, 29-, and 33-mm anvil sizes.13 The OrVil™ device is delivered transorally and is therefore not sterile when the tubing is delivered via the oesophagus. Some concerns about wound infection have been raised; this series had one postoperative thoracic infective complication (secondary to anastomotic leak) and two wound infections severe enough to warrant medical intervention (grade II).14 Further concerns have been raised with regard to oesophageal

mucosal injury by the anvil; however, our series demonstrated no evidence of this. With correct insertion of the OrVil™, we believe oesophageal mucosal trauma is less likely than with other conventional staplers in which the anvil head is inserted directly through the distal oesophagus. Technical complications using the OrVil™ are uncommon. There are however some common mistakes that can occur when using the device, and potential pitfalls (and solutions) are outlined in Table 1. On a single occasion, the EEA XL gun would not engage with the anvil despite multiple efforts. This was a result of damage to the tips of the anvil centre rod and necessitated salvage with an interrupted handsewn anastomosis.

Conclusion The OrVil™ circular stapler is relatively easy to use, produces a reliable and reproducible double-layered staple anastomosis, and reduces some of the technical difficulty when performing oesophageal anastomoses. Anastomotic leak rates and stricture formation compare favourably with historical outcomes using conventional anastomotic methods. Acknowledgments We thank Quoc Nguyen from Medical Art & Design, Royal Adelaide Hospital for creating the figures to illustrate our operative technique.

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J Gastrointest Surg 8. Jaroszewski DE, Williams DG, Fleischer DE, Ross HJ, Romero Y, Harold KL. An early experience using the technique of transoral OrVil EEA stapler for minimally invasive transthoracic esophagectomy. Ann Thorac Surg 2011;92:1862–1869. 9. Cunningham D, Allum WH, Stenning SP, Thompson JN, Van de Velde CJ, Nicolson M, Scarffe JH, Lofts FJ, Falk SJ, Iveson TJ, Smith DB, Langley RE, Verma M, Weeden S, Chua YJ, MAGIC Trial Participants. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med 2006;355:11– 20. 10. Baigrie RJ, et al. Synchronous combined oesophagectomy in the ‘French’ position. Dis Esophagus 1996;9:226–227. 11. Urschel JD, Blewett CJ, Bennett WF, Miller JD, Young JE. Handsewn or stapled esophagogastric anastomoses after

esophagectomy for cancer: meta-analysis of randomized controlled trials. Dis Esophagus 2001;14:212–217. 12. Campos GM, Jablons D, Brown LM, Ramirez RM, Rabl C, Theodore P. A safe and reproducible anastomotic technique for minimally invasive Ivor Lewis oesophagectomy: the circularstapled anastomosis with the trans-oral anvil. Eur J Cardiothorac Surg 2010;37:1421–1426. 13. Blackmon SH, Correa AM, Wynn B, Hofstetter WL, Martin LW, Mehran RJ, Rice DC, Swisher SG, Walsh GL, Roth JA, Vaporciyan AA. Propensity-matched analysis of three techniques for intrathoracic esophagogastric anastomosis. Ann Thorac Surg 2007;83:1805–1813. 14. Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 2004;240:205–213.

Proximal anastomosis using the OrVil circular stapler in major upper gastrointestinal surgery.

Anastomoses in major upper gastrointestinal surgery can be technically demanding, especially handsewn anastomoses traversing the diaphragmatic hiatus...
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