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Pyloric injection of botulinum toxin for treatment of diabetic gastroparesis
*'391 PEG PLACEMENT FOR HEAD AND NECK CANCER REVISITED: INCREASED COMPLICATIONS WARRANTS CAUTIOUS APPROACH Nitesh Ratnakar, The Chicago Medical Sch, North Chicago, IL; Russell D. Brown, Rama P. Venu, Univ of Illinois at Chicago, Chicago, IL Introduction: H&N Ca and neurologic disease are common indications for PEG placement. It has been suggested that PEG complications may be higher in H&N Ca patients, but some studies, including one from our institution (Ann Otol Rhino Laryng 1992 101:46-50) have shown no difference. As treatment for H&N Ca has evolved, and now often includes chemotherapy and radiation therapy (Ch/RT) after PEG, we restudied recent patients to determine whether PEG complications have increased and to determine possible causative factors. Methods: All patients undergoing PEG for nutrition from 2/99-7/2000 were studied. Our institution's C-more database, complete inpatient and outpatient chart system, and f/u phone calls were used to verify course and complications. Demographics, co-morbid illness, treatment and outcome of PEG complications and elements of post PEG care was assessed. Complications were defined as major (Ulcer/bleeding, severe infection, buried bumper, fistula, tumor implant) or minor. Results: A total of 137 patients with successful PEG were studied: 59 H&N Ca (44M/15F, mean age 56.9 yrs), 78 neurologic disease (35M/43F, mean age 62.6 yrs), Duration of flu, albumin, co-morbidity, and PEG technique were similar between groups. The H&N Ca patients had significantly higher rates of total, major, and recurrent complications, and earlier complications compared to the Neurologic group (See table below, *p-<0.05). One death due to PEG occurred in the H&N Ca group (ulcer bleed). All H&N Ca PTS (59/59) had Ch/RT before or after PEG. Eighteen of the 38 pts exposed to Ch/RT within 20 days of PEG had complications, vs. only 2 of 21 pts exposed to Ch/RT after 20 days or more(47% vs 9.5%, p<0.05,relative risk 4.9 for complication w/earlier Ch/RT). Conclusions: Head and neck cancer patients undergoing PEG recently at our institution had more major and minor complications than neurologic patients, and had complications earlier. Our data suggests these complications may be attributable to chemotherapy and radiation given before or soon after PEG placement. Administration of chemotherapy and radiation more than 20 days after PEG placement, and close monitoring for complications are recommended for these at-risk patients.
Pt,Group
No. of Pts.
Tot.Comp
Maj. Comp
Recur.cornp Time to comp
H&N Ca
59
Neurologic
78
20 (33.9%}" 8 (10.3%)
9 {15.3%)"
12 (60%)"
2 (2.6%)
2 (25%)
36_+37 days" 127-+106 days
**392 PYLORIC I N J E C T I O N OF BOTULINUM TOXIN F O R TREATMENT OF DIABETIC GASTOPARESIS Dina Z. Ezzeddine, veterans affairs med ctr/Wright state Univ, Dayton, OH; Raj Jit, Nell Katz, Manoop Bhutani, Narisminih Gopaiswamy, same BACKGROUND: Diabetic gastroparesis affects up to 58% of diabetics. The pathophysiology includes antral hypomotility, increased compliance of the fundus, decreased gastroduodenal gradient and prolonged pyloric contractions. The latter may cause functional resistance to gastric outflow. Botulinum toxin has been used in several neuromuscular and gastrointestinal diseases like achalasia . We describe the use of Botulinum toxin injection into the pyloric sphincter in an attempt to decrease pyloric resistance and improve gastric emptying in an ongoing pilot study of 10 patients. METHODS: Six patients with diabetes mellitus type 2 for more than 10 years were included in this study so far. Inclusion criteria were: a. symptoms of nausea, vomiting and bloating and b. abnormal gastric emptying ~tudy (GES) by radionuclide scan using 99m technetium sulfur colloid. Patients with peptic ulcer disease or gastric surgery were excluded. An upper endoscopy was performed within 2 months of the baseline GES. 100 units of Botulinum toxin were diluted in 4 cc of saline and injected with the ~clerotherapy needle into the 4 quadrants of the pyloric sphincter (25 units
VOLUME 53, NO. 5, 2001
per quadrants). Follow up GES was done at 48 hours and 6 weeks post injection. Patients were interviewed about symptoms of nausea, vomiting and bloating and a score was obtained at baseline before endoscopy and 2 and 6 weeks post endoscopy. The score ranged from 0 to 3 for each symptom. RESULTS: Patients were symptomatic for more than 6 months (range 6 months to 4 years). All patients were on metoclopramide during the study. All patients had cisapride in the past. None of the patients had side effects from the endoscopy or Botulinum toxin. There was an average of 55 percent improvement in the subjective score at 2 weeks compared to baseline (range, 14 to 80 percent). This improvement was maintained at 6 weeks. GES at 48 hours post injection has improved by 63 percent (range, 25 to 100 percent). Six weeks follow up GES has improved by 43 percent (range, 17 to 99 percent). CONCLUSION: We describe a novel use of Botulinum toxin in the treatment of diabetic gastroparesis. Betulinum toxin injection of the pylorus is safe. It has resulted in clinical improvement that was maintained for 6 weeks. The scintigraphic improvement was more pronounced at 2 weeks compared to 6 weeks. Further evaluation of the benefits of Botulinum toxin in diabetic gastroparesis is warranted.
**393 EFFICACY, SAFETY AND CLINICAL OUTOMES OF ENDOSCOPIC MUCOSAL RESECTION (EMIt): A STUDY OF 101 LESIONS Nuzhat A. Ahmad, Michael L. Kochman, William B. Long, Gregory G. Ginsberg, Hosp of the Univ of Pennsylvania, Philadelphia, PA Background: EMR offers an alternative to surgery for removal of superficial neoplastic lesions of gastrointestinal tract Aim: Assess safety efficacy and clinical outcomes of EMR Methods: Data on consecutive EMR was collected prospectively from 2/97 onwards. EMR was performed using suction cap or strip biopsy technique. EUS was performed using GF-UM20 echoendoscope or 20MHz miniprobe. Complications were immediate (<24 hrs after EMR) or delayed (>24 hrs after EMR). Survival was assessed in patients with adenoca or HGD on final pathology who had undergone complete excision of their lesions. Survival was assessed from the time of EMR to 11130/00 Results: Total of 101 lesions resected in 92 patients. Indications for EMR were adenoca (11%), HGD (13%), lesions of unknmvn etiology (10%), adenomas (63%) and prior incomplete resections (3%). Location:esophagus (19%), gastric (14%), duodenum (27%), rectum (12%) colon (29%). Mean size was 2.1cm (0.5-7). Lesions characterized as fiat (6%), nodular (21%), sessile (69%) and carpet like (4%). Resectability assessed by EUS in 62% cases. Suction Cap technique used in 26 cases (26%) and strip biopsy technique in 74 cases (74%). Mean amount of saline injected was 10cc (2-44cc). Complete excision of the lesion in 89% of cases. Complete excision was not influenced by size or characteristics of lesions. Of those who had complete excision, 17% required more than one session (10% required 2, 6% required 3 and 1% required 4 sessions respectively). Carpet like lesions were most likely to require >1 treatment session (p=0.002). Final pathology revealed adenoca (17%), HGD (13%), adenomas (47%), benign (18%), LGD (3%) and carcinoid (3%). EMR resulted in change in diagnosis in 46% of cases. In 6/24 (25%) lesions that had adenoca or HGD on initial biopsy, EMR resulted in downgrading of pathology. In 12/30 (40%) lesions that had an adenoma or benign pathology on initial biopsy, EMR resulted in a final pathology of adenoca or HGD. Bleeding was the only complication(immediate 16, delayed 6). Endoscopic t r e a t m e n t required in 88% of immediate and 33% of delayed bleeders. Increased lesion size was the only significant variable associated with bleeding (p=0.003). The mean cancer free survival in patients with adenoca was 21 months (2-30months) and in patients with HGD was 23 months (546months). Conclusion: EMIt was associated with a higher risk of bleeding than standard polypectomy. EMR achieved complete resection in majority of patients. Two year survival data compares favorably with surgery
GASTROINTESTINAL ENDOSCOPY
AB63
Pt,Group
No. of Pts.
Tot.Comp
Maj. Comp
Recur.cornp Time to comp
H&N Ca
59
Neurologic
78
20 (33.9%}" 8 (10.3%)
9 {15.3%)"
12 (60%)"
2 (2.6%)
2 (25%)
36_+37 days" 127-+106 days
**392 PYLORIC I N J E C T I O N OF BOTULINUM TOXIN F O R TREATMENT OF DIABETIC GASTOPARESIS Dina Z. Ezzeddine, veterans affairs med ctr/Wright state Univ, Dayton, OH; Raj Jit, Nell Katz, Manoop Bhutani, Narisminih Gopaiswamy, same BACKGROUND: Diabetic gastroparesis affects up to 58% of diabetics. The pathophysiology includes antral hypomotility, increased compliance of the fundus, decreased gastroduodenal gradient and prolonged pyloric contractions. The latter may cause functional resistance to gastric outflow. Botulinum toxin has been used in several neuromuscular and gastrointestinal diseases like achalasia . We describe the use of Botulinum toxin injection into the pyloric sphincter in an attempt to decrease pyloric resistance and improve gastric emptying in an ongoing pilot study of 10 patients. METHODS: Six patients with diabetes mellitus type 2 for more than 10 years were included in this study so far. Inclusion criteria were: a. symptoms of nausea, vomiting and bloating and b. abnormal gastric emptying ~tudy (GES) by radionuclide scan using 99m technetium sulfur colloid. Patients with peptic ulcer disease or gastric surgery were excluded. An upper endoscopy was performed within 2 months of the baseline GES. 100 units of Botulinum toxin were diluted in 4 cc of saline and injected with the ~clerotherapy needle into the 4 quadrants of the pyloric sphincter (25 units
VOLUME 53, NO. 5, 2001
per quadrants). Follow up GES was done at 48 hours and 6 weeks post injection. Patients were interviewed about symptoms of nausea, vomiting and bloating and a score was obtained at baseline before endoscopy and 2 and 6 weeks post endoscopy. The score ranged from 0 to 3 for each symptom. RESULTS: Patients were symptomatic for more than 6 months (range 6 months to 4 years). All patients were on metoclopramide during the study. All patients had cisapride in the past. None of the patients had side effects from the endoscopy or Botulinum toxin. There was an average of 55 percent improvement in the subjective score at 2 weeks compared to baseline (range, 14 to 80 percent). This improvement was maintained at 6 weeks. GES at 48 hours post injection has improved by 63 percent (range, 25 to 100 percent). Six weeks follow up GES has improved by 43 percent (range, 17 to 99 percent). CONCLUSION: We describe a novel use of Botulinum toxin in the treatment of diabetic gastroparesis. Betulinum toxin injection of the pylorus is safe. It has resulted in clinical improvement that was maintained for 6 weeks. The scintigraphic improvement was more pronounced at 2 weeks compared to 6 weeks. Further evaluation of the benefits of Botulinum toxin in diabetic gastroparesis is warranted.
**393 EFFICACY, SAFETY AND CLINICAL OUTOMES OF ENDOSCOPIC MUCOSAL RESECTION (EMIt): A STUDY OF 101 LESIONS Nuzhat A. Ahmad, Michael L. Kochman, William B. Long, Gregory G. Ginsberg, Hosp of the Univ of Pennsylvania, Philadelphia, PA Background: EMR offers an alternative to surgery for removal of superficial neoplastic lesions of gastrointestinal tract Aim: Assess safety efficacy and clinical outcomes of EMR Methods: Data on consecutive EMR was collected prospectively from 2/97 onwards. EMR was performed using suction cap or strip biopsy technique. EUS was performed using GF-UM20 echoendoscope or 20MHz miniprobe. Complications were immediate (<24 hrs after EMR) or delayed (>24 hrs after EMR). Survival was assessed in patients with adenoca or HGD on final pathology who had undergone complete excision of their lesions. Survival was assessed from the time of EMR to 11130/00 Results: Total of 101 lesions resected in 92 patients. Indications for EMR were adenoca (11%), HGD (13%), lesions of unknmvn etiology (10%), adenomas (63%) and prior incomplete resections (3%). Location:esophagus (19%), gastric (14%), duodenum (27%), rectum (12%) colon (29%). Mean size was 2.1cm (0.5-7). Lesions characterized as fiat (6%), nodular (21%), sessile (69%) and carpet like (4%). Resectability assessed by EUS in 62% cases. Suction Cap technique used in 26 cases (26%) and strip biopsy technique in 74 cases (74%). Mean amount of saline injected was 10cc (2-44cc). Complete excision of the lesion in 89% of cases. Complete excision was not influenced by size or characteristics of lesions. Of those who had complete excision, 17% required more than one session (10% required 2, 6% required 3 and 1% required 4 sessions respectively). Carpet like lesions were most likely to require >1 treatment session (p=0.002). Final pathology revealed adenoca (17%), HGD (13%), adenomas (47%), benign (18%), LGD (3%) and carcinoid (3%). EMR resulted in change in diagnosis in 46% of cases. In 6/24 (25%) lesions that had adenoca or HGD on initial biopsy, EMR resulted in downgrading of pathology. In 12/30 (40%) lesions that had an adenoma or benign pathology on initial biopsy, EMR resulted in a final pathology of adenoca or HGD. Bleeding was the only complication(immediate 16, delayed 6). Endoscopic t r e a t m e n t required in 88% of immediate and 33% of delayed bleeders. Increased lesion size was the only significant variable associated with bleeding (p=0.003). The mean cancer free survival in patients with adenoca was 21 months (2-30months) and in patients with HGD was 23 months (546months). Conclusion: EMIt was associated with a higher risk of bleeding than standard polypectomy. EMR achieved complete resection in majority of patients. Two year survival data compares favorably with surgery
GASTROINTESTINAL ENDOSCOPY
AB63