To evaluate the efficacy of the BAP patch, researchers accessed the stomach through an incision in the abdominal wall, removed an 8x8 cm. portion from the front stomach wall and replaced it with the patch. At four, eight and 12 weeks following implantation, the implanted area was examined in total and histological, or cell-level, assessments.
All of the subjects survived the evaluation period without decreases in fluid or food intake. At four to eight weeks following implantation, the implantation site showed daily reduction of the patch. At 12 weeks, the implantation site was nearly indistinguishable from the original gastric wall in appearance. A closer look confirmed the growth of mucosa and submucosa, two of the innermost layer of the gastric wall, and a muscle layer similar to the original wall. Subtle differences between the artificial and original wall were confirmed in the connective tissue, including somewhat reduced amounts of elastic fiber and smooth muscle density compared to the original gastric wall.
"Currently, the surgical options available for treatment of gastric diseases and stomach tumors are disabling," said Mitsuo Miyazawa MD, PhD, professor in the department of surgery, Saitama Medical University. "This technique has potential as a novel treatment to repair a defective GI tract while preserving full GI function."
The investigators plan to study the gastric function and preservation of organ shape with the BAP patch over a longer period of time. They also plan to investigate the patch's use in the small and large intestines.
Miyazawa cautioned that while these results are promising, the treatment must still be tested in humans in a clinical trial within a global cooperative structure.
Dr. Yasuko Toshimitsu, MD, PhD will present these data on Tuesday, May 4 at 4:30 p.m. CT in 292, Ernest N. Morial Convention Center.
Complex Laparoscopic Procedures Can Be Safely Performed Early
|Contact: Amy Levey|
Digestive Disease Week