Serious complication following use of StomaphyX

Roux-en-Y gastric bypass (RYGB) is a popular surgical procedure to treat morbid obesity [1]. StomaphyX (endoGastric Solutions Inc., Redmond, Washington, USA) is designed for incisionless transoral endoscopic plication and revision of the gastric pouch (EPRGP) in case of pouch dilation with weight gain [2] [3]. Nonresorbable polypropylene fasteners create full-thickness plications of the pouch wall, reducing its volume. StomaphyX was cleared by the Food and Drug Administration (FDA) in April 2007 [4] and clinical results are becoming available, with only 3 % early complications [5].

We present the case of a 38-year-old woman who underwent StomaphyX EPRGP in 2007, after RYGB in 2000. The procedure was carried out in a peripheral hospital by a surgeon and was not planned within the regulations governing ongoing clinical trials. After 3 days, the patient was referred to our hospital with fever and thoracic pain. Thoracic X-ray showed left lung empyema ([Fig. 1]). Antibiotics were started and she underwent two thoracic surgical procedures to drain the left hemithorax and to remove the pleural membranes ([Fig. 2]). Upper gastrointestinal endoscopy showed three StomaphyX fasteners through the distal oesophageal wall and a dilated gastric pouch with another three fasteners around the gastrojejunostomy ([Fig. 3]). Because of persistent empyema, a third draining thoracotomy was carried out 14 days later, which revealed adhesions at the distal esophagus. Streptococcus viridans and non-aureus Staphylococcus were cultured and antibiotics started. After a 28-day stay in the hospital, the patient was fit enough to be discharged. At present, 4 years after the complicated StomaphyX procedure, the patient is still under treatment for postoperative neuralgic pain of the left hemithorax. She was not covered by a clinical trial insurance. This case report illustrates the risk of serious complications of StomaphyX and the ethical implications of using new devices outside the control of regulated clinical trials.

Fig. 1 Chest X-ray showing left lung empyema with a thoracic drain.

Fig. 2 Thoracic computed tomography (CT) scan showing empyema and mediastinitis with a surgical thoracic drain.

Fig. 3 Endoscopic image of the gastric pouch showing inadequate placement of fasteners around the gastrojejunostomy.

Endoscopy_UCTN_Code_CPL_1AH_2AJ

References

• 1 Thompson C C, Slattery J, Bunddga M E, Lautz D B. Peroral endoscopic reduction of dilated gastrojejunal anastomosis after Roux-en-Y gastric bypass: a possible new option for patients with weight regain.  Surg Endosc. 2006;  20 1744-1748
• 2 Elder K A, Wolfe B M. Bariatric surgery: a review of procedures and outcomes.  Gastroenterology. 2007;  132 2253-2271
• 3 Mikami D, Needleman B, Narula V et al. Natural orifice surgery: initial US experience utilizing the StomaphyX device to reduce gastric pouches after Roux-en-Y gastric bypass.  Surg Endosc. 2010;  24 223-228
• 4 Gibson S. Endoscopic solutions receives FDA clearance for first transoral surgical product: StomaphyXTM gets clearance first (April 2, 2007). Available from http://www.egseurope.com Accessed: November 15, 2010
• 5 Leitman I M, Virk C S, Avgerinos D V et al. Early results of trans-oral endoscopic plication and revision of the gastric pouch and stoma following Roux-en-Y gastric bypass surgery.  JSLS. 2010;  14 217-220