Jose G. De la Mora

Initial evaluation of the efficacy and safety of endoscopic ultrasound-guided direct ganglia neurolysis and block

BACKGROUND:Celiac plexus neurolysis and block are considered safe but provide limited pain relief. Standard techniques target the region of the celiac plexus but do not attempt injections directly into celiac ganglia. The recent recognition that celiac ganglia can be visualized by endoscopic ultrasound (EUS) now allows direct injection into celiac ganglia for neurolysis (CGN) and block (CGB).AIMS:To determine the safety and initial efficacy (at 2–4 wk) of direct ganglia injection in patients with moderate to severe pain secondary to unresectable pancreatic carcinoma or chronic pancreatitis.METHODS:An EUS database was reviewed to identify patients undergoing CGN and CGB. Data were retrieved from the medical records and phone follow-up.RESULTS:Thirty-three patients underwent 36 direct celiac ganglia injections for unresectable pancreatic cancer (CGN N = 17, CGB N = 1) or chronic pancreatitis (CGN N = 5, CGB N = 13) with bupivacaine (0.25%) and alcohol (99%) for CGN, or Depo-Medrol (80 mg/2 cc) for CGB. Cancer patients reported pain relief in 16/17 (94%) when alcohol was injected and 0/1 (00%) when steroid was injected. For chronic pancreatitis, 4/5 (80%) who received alcohol reported pain relief versus 5/13 (38%) receiving steroids. Thirteen (34%) patients experienced initial pain exacerbation, which correlated with improved therapeutic response (P < 0.05). Transient hypotension and diarrhea developed in 12 and 6 patients, respectively.CONCLUSIONS:Initial experience suggests that EUS-guided direct celiac ganglion block or neurolysis is safe. Alcohol injection into ganglia appears to be effective in both cancer and chronic pancreatitis. Prospective trials are needed to confirm the efficacy of this new approach.

In Vivo Full-Thickness Endoluminal Gastroplication Using Tissue Anchors in a Live Pig Model

In Vivo Full-Thickness Endoluminal Gastroplication Using Tissue Anchors in a Live Pig Model Jose G. De la Mora, Elizabeth Rajan, David Rea, Thomas C. Smyrk, Lori J. Herman, Jodie L. Deters, Mary A. Knipschield, Christopher J. Gostout Background: Long-term success of gastric wall apposition performed by flexible endoscopy is dependent on fold permanence. Prior work by our group demonstrated that only full-thickness folds with serosal apposition are durable. Aim: To study feasibility of different tissue anchors to create a full thickness inverted fold and the durability of each single fold plication. Material & Methods: Four 35-45 Kg female pigs were used. Under anesthesia a midline abdominal incision was performed. A 5-cm incision parallel to the greater curvature of the stomach was made. The posterior wall was exposed and longitudinal folds were created by indenting the wall from the serosal side (inverted fold) 1.5 cm in height and 5 cm long. Anchors were deployed to traverse the inverted gastric wall, including apposing serosal surfaces within the fold. Anchors were 1 cm apart with 3-4 of the same type used per fold. 4-6 folds were made in each pig. Four types of paired anchors joined with suture (prolene 2-0) were used: T-bar (T); polypropylene mesh pledget (TM); plastic star-shaped buttons (S) and a self-expanding nitinol basket (B). Suture (vicryl 2-0) for incision closure was used to control for tissue reaction. Follow-up endoscopy was done at 15, 30 and 60 days. Two pigs were sacrificed each at 30 and 60 days. Macroscopic description of the folds was done and samples of the folds sent for histology. Results: Day 15: all folds were still present endoscopically. Day 30: S and B folds were unchanged, TM folds were reduced in height, and T folds had flattened. Day 60: only S & B folds remained. Histologically, all B folds included the muscle layer (30 & 60 day specimens) and one developed serosal fusion (30-day specimen). Only one S fold included the muscle layer with serosal fusion at 60 days. Conclusions: The durability of endoluminally placed full thickness inverted folds remains a challenge. Serosal apposition remains requisite for fold permanence. The use of tissue anchors such as the S and B designs may help achieve greater durability for endoscopic gastric remodeling by tissue apposition. Abstracts

Outcomes of Colonic Stenting Using a Specifically Designed Expandable Metal Colonic Stent (Ultraflex™ Precision)

Outcomes of Colonic Stenting Using a Specifically Designed Expandable Metal Colonic Stent (Ultraflex Precision) Jose G. de la Mora, Todd Baron, Christopher Gostout, Nicole Pochron Background: Colonic stenting is now accepted for obstructing lesions, either as a temporary or definitive treatment. Until now, studies have used stents not designed specifically for use in the colon. The Ultraflex Precision stent is designed specifically for the colon, with a larger diameter (25 vs 20 mm), proximal flare (30 mm) and atraumatic ends. The aim of this study is to describe the results using this stent at our institution. Material & Methods: A retrospective review of patients that underwent placement of this stent (S), were included. Variables were: diagnosis, site, need for dilation, use of fluoroscopy, S length, placement success, complications, follow-up and final outcome. Results: 38 S were placed in 30 patients. In 6 cases 2 S were used and 3 S in one patient. Diagnosis was: cancer in 23, post-radiation in 2 and 1 each for: diverticular stricture, crohn’s, extrinsic tumor, anastomotic stricture and pancreatitis with colonic involvement. 13 lesions were located in descending colon, 15 in rectosigmoid and 2 in transverse. S lengths used were 5.7 cm (10), 8.7 cm (20) and 11.7 cm (8). Fluoroscopy was used in 28 patients with endoscopic control in 23. No dilatation was performed in 26; in 3 cases dilatation was performed after deployment . Placement success was 27/30 (90%) with two misplaced & repositioned S, and 1 that failed to expand. Severe pain occurred in 6 cases, evident perforation in 2 and suspected perforation (with late abscess formation) in 2 patients. One pt. experienced bacteremia with fever. Both evident perforations occurred in cancer pts. , The two cases with abscess formation occurred in benign disease (pancreatitis and post-radiation). Colostomy was performed in 2 and conservative treatment in two, one of which died from disease progression. Follow-up was available in 24, for a mean of 2 months (1-180 days). No stent malfunction was seen in 21 (2 abscess excluded) up to proctocolectomy (in 5) or death from disease progression (in 4). One stent required trimming. One intraoperative perforation occurred at the stent site. Conclusions: Placement success is similar to previous series using other types of stents not specifically designed for the colon. No migrations occurred, and other complications presented also at a similar rate. The later cases could be due to the fact that they were not neoplastic, although the increased diameter of the new stents cannot be excluded as an additional factor. Abstracts

A New Expandable Metal Hybrid Esophageal Stent: Results From an Animal Model

A New Expandable Metal Hybrid Esophageal Stent: Results From an Animal Model Jose Guillermo de la Mora, Nicole L. Pochron, Todd H. Baron Background: Self-expandable metal stents (SEMS) are a primary method for palliation of malignant dysphagia. SEMS imbed in tissue and promote granulation tissue preventing removal. Recently removable self-expandable plastic stents (SEPS) have been used for treatment of refractory benign esophageal strictures. SEMS and SEPS each offer unique features. However the ideal stent that does not imbed in tissue, prevents granulation tissue, does not migrate, yet is removable, does not yet exist. Objectives: To evaluate the tissue response in a porcine model induced by a new hybrid esophageal stent designed to offer the advantages of both SEMS and SEPS. The stent is completely coated internally rather than externally which prevents tumor ingrowth and imbedding and may limit tissue hyperplasia. Methods: Study stents (Alveolus ES-STS (TM), 25 mm proximal flange, 23 mm distal flange, 18 mm mid-body diameter, 7 cm long, fully covered internally) and control stents (Ultraflex (TM) stent, Microvasive, 23 mm proximal flange, 18 mm midbody, covered externally) were implanted in the esophagus of 8 Yucatan pigs. Each animal underwent placement of two stents: one study stent and one control stent, placed proximally and distally. The location within the esophagus of the study and control stents was assigned randomly placed in each pig. Followup endoscopy was performed 1, 2, 3 and 5 weeks post-implantation, allowing assessment of the extent of granulation tissue formation and esophageal injury caused by the stent. Granulation tissue was estimated as mild, moderate, or severe. Ease of stent removal was assessed at 2 week and 5 week post-placement. Results: The endoscopic tissue hyperplasia response of the new hybrid study stents was graded as mild to moderate. All stents were easily removed from the esophagus without difficulty and atraumatically. In contrast, the control stents produced severe granulation tissue formation with complete embedding of the uncovered stent ends. Removal was possible by resulted trauma to the esophagus and endoscopically visible bleeding. Histopathologic findings are pending. Conclusions: Based upon preliminary findings in the normal porcine esophagus this novel internally covered self-expanding metal stent appears to resist tissue imbedding and tissue hyperplasia and allows removability. Future studies are Abstracts