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A prospective randomized trial of TIPS vs small diameter prosthetic H-graft portacaval shunt in the treatment of bleeding varices
AI058 SSAT ABSTRACTS
GASTROENTEROLOGY Vol. 118, No.4
3582
3716
FIBRIN GLUE FOR ALL ANAL FISTULAS. Stephen M. Sentovich, Boston Univ Med Ctr, Boston, MA.
COMBINATION OF ENDOSCOPIC ARGON PLASMA COAGULATION (EAPC) AND ANTIREFLUX SURGERY FOR TREATMENT OF BARRETT'S ESOPHAGUS. Harald Tigges, Karl H. Fuchs, Joern Maroske, Martin Fein, Arnulf Thiede, Dept of Surg, Univ of Wuerzburg, Wuerzburg, Germany.
Purpose: Since any division of anal sphincter muscle can result in varying degrees of fecal incontinence, the aim of this study was to determine if a new sphincter muscle-sparing technique using fibrin glue was effective in closing all types of anal fistulas. Methods: All patients with anal fistulas presenting to a single surgeon over a one year period were treated with fibrin glue. Six to eight weeks after drainage of any associated abscess and placement of a seton, the fistula tract(s) were debrided and then closed with either autologous fibrin glue or commercially available fibrin sealant. Results: Twenty fibrin glue fistula closures were performed in 17 consecutive patients. Etiology of the anal fistulas was anorectal suppurative disease in 11, Crohn' s disease in 4, suppurative disease plus HN in 1, and rectal cancer after local excision and radiation therapy in 1 patient. Median follow-up time was 7 months. Functional results have remained excellent with no patient reporting any change in continence after treatment. Fibrin glue closure of the anal fistula was successful in 13 patients (76%). In 3 of the 4 patients whose fistulas did not close, a second instillation of fibrin glue was successful in 2 cases for an overall anal fistula closure rate of 88% (15/17). The two patients that failed fibrin glue had complicated fistula disease associated with Crohn' s disease in one patient and numerous previous fistulotomies in the other patient. Conclusion: Fibrin glue is simple and effective treatment of all anal fistulas with excellent functional results. 3715 A PROSPECTIVE RANDOMIZED TRIAL OF TIPS VS SMALL DIAMETER PROSTHETIC H-GRAFT PORTACAVAL SHUNT IN THE TREATMENT OF BLEEDING VARICES. Al S. Rosemurgy, F. M. Serafini, T. Black, B. Zweibel, B. Kudryk, 1. H. Nord, S. B. Goode, Univ of South Florida, Tampa, FL. Objective: To determine the efficacy of TIPS vs 8 mm prosthetic H-graft portacaval shunt in the definitive treatment of bleeding varices due to portal hypertension through extended follow-up of our expanded randomized clinical trial. Methods: 132 consecutive patients were prospectively randomized to undergo TIPS or 8 mm prosthetic H-graft portacaval shunt (HGPCS). Both shunts were undertaken as definitive therapy. All patients had bleeding varices not amenable to or failing sclerotherapy/banding. Patients were excluded prior to randomization if chances for survival were hopeless. Failure of shunting was defined as technical inability to complete the shunt, irreversible shunt occlusion. major variceal rehemorrhage, hepatic failure leading to transplantation, or death. Data are reported as a mean z STD, when appropriate. Results: Follow up ranged from 1Yz to 6 Yz years, and averaged 4.0 years :!: 1.5 for TIPS and 3.9 years z 1.7 for HGPCS. (See Table 1) TIPS could not be placed in 2 patients. The postshunt portal vein - IVC pressure gradient was 9.0 mmHg :!: 4.1 after TIPS and 5.3 mmHg :!: 3.0 after HGPCS (p<0.05, Student's t-test). Periop deaths occured in 10 patients after TIPS and in 13 after HGPCS. To maintain shunt patency after TIPS there were 49 therapeutic interventions in 19 patients, while after HGPCS there were 6 interventions in 5 patients. After TIPS, 42 (64%) patients failed (experiencing 51 occurrences of failure), while 23 (35%) patients failed after HGPCS (experiencing 24 occurrences of failure). Shunt failure and interventions to maintain shunt patency were each significantly more frequent after TIPS (p<0.OO2, Fisher's Exact Test) (See Table 2) Conclusions: TIPS and HGPeS provide partial portal decompression, though portal pressures are lower after HGPCS. In the definitive management of portal hypertension, TIPS requires more interventions and is more frequently associated with shunt dysfunction, shunt failure, and hepatic failure. Despite vigilance in maintaining patency, TIPS provides less optimal outcomes than the 8 mm prosthetic H-graft portacaval shunts for patients with bleeding varices due to portal hypertension. Shunt
Number
Age (Years)
Cinflosis
Child's Ciass
TiPS HGPCS
66 66
55±12.5 54±13.0
70%ETOH 74% ETOH
12A, 258, 29C 9A, 248, 33C
Shunt
Rebieed
irreversibie Occlusion
Transplantation
Deaths
TIPS HGPCS
11 2'
4 2
5 0'
29 20
• Less than after TIPS, p
Purpose: Intestinal metaplasia in columnar lined epithelium of the esophagus is a premalignant condition. Neither medical nor surgical treatment proved substantial regression of Barrett's epithelium. Endoscopic argon plasma coagulation (EAPC) of the columnar lined epithelium in the esophagus is discussed controversial. The purpose of this pilot study was to evaluate the technical performance, the potential sideeffects and possible success regarding regression of Barrett's epithelium after EAPC and antireflux surgery. Methods: 30 patients with Barrett's esophagus were treated from August 1996 until December 1998. Regeneration of esophageal mucosa was achieved within several EAPCs. 24 h - hospitalization as well as treatment under general anesthesia was obligatory for these patients. All patients were on proton pump inhibitors. Endoscopic follow up was performed 4 - 6 weeks after the last session. Antireflux surgery (Nissen) was done after complete regeneration of squamous epithelium. One year after laparoscopic fundoplication and EAPC follow up with endoscopy and standardized quadrant biopsies of the esophagus, 24 h pH - measurement, and esophageal manometry was performed. Results: All 30 patients showed complete regeneration of squamous epithelium after median 3 (1 7) sessions of EAPC. 14 patients underwent I year follow up studies. All showed endoscopically a correct fundic wrap. In 2 patients Barrett's epithelium recurred without dysplasia again limited to a short segment of < I em. Corresponding to this findings these 2 patients showed recurrent acid reflux. Conclusions: Our results indicate that the combination of EAPC and antireflux surgery is an effective and safe treatment for gastroesophageal reflux disease. Long term follow up of this therapy is necessary to evaluate the patients benefit by regression of Barrett's epithelium in the majority of cases regarding cancer prevention. 3717 ENDOSCOPIC MANAGEMENT OF EARLY UPPER GASTROINTESTINAL INVASIVE CANCERS IN HIGH RISK PATIENTS. Neville Menezes, Chris 1. Shearer, C. Ross Carter, Robert C. Stuart, Glasgow Royal Infirmary, Glasgow, United Kingdom; Univ of Glasgow, Glasgow, United Kingdom. Background: Early upper GI malignancy is rare in Western populations. Although surgical resection offers the best prospects for cure, not all patients are fit to undergo major surgery due advanced age and co-morbid cardio-respiratory illness. Recent advances in endoscopic therapy may offer the chance of cure for some of these patients with early tumors, without the need for surgical resection. Aims: A retrospective evaluation of the endoscopic management of patients with early upper GI cancer, considered unsuitable for surgical resection on account of high risk due to co-morbid disease. Methods: Eighteen patients with early invasive upper GI tumors were treated endoscopically. All were ASA grade >3 . Median age was 74.5 years, range 68 - 96. There were 8 esophageal, 7 gastric and 3 duodenal lesions. Endoscopic Mucosal Resection (EMR) was performed in 10 patients. Laser therapy (Nd: YAG) was performed in 8 patients when the lesion was too extensive for EMR or associated with a wide field change effect. After EMR residual dysplasia or tumor (n=5) detected on biopsy at follow-up endoscopy was treated by laser therapy. The treatment sites were subsequently monitored endoscopically with biopsies performed at regular intervals. Results: At a median follow-up of 18 months (range, 1 - 44 months) complete endoscopic and pathological tumor ablation was seen in 14 patients with four patients currently undergoing further laser therapy. Of the 10 EMR patients 8 cancers were Tl and 2 involved the muscularis propria, T2. There was no mortality related to the endoscopic treatment and none of the patients have died of the tumor. Bleeding occurred in one patient after an EMR and two patients developed a perforation, one after an EMR and the other from laser treatment. All three patients had an uneventful recovery with conservative non-operative management. 2 patients developed an esophageal stricture after laser treatment which were amenable to balloon dilatation. Conclusion: In patients deemed unfit for major surgery, endoscopic treatment of early upper GI cancers appears to be an effective modality of treatment. EMR and laser therapy are useful complementary techniques particularly when dealing with large lesions associated with a wide field change.
GASTROENTEROLOGY Vol. 118, No.4
3582
3716
FIBRIN GLUE FOR ALL ANAL FISTULAS. Stephen M. Sentovich, Boston Univ Med Ctr, Boston, MA.
COMBINATION OF ENDOSCOPIC ARGON PLASMA COAGULATION (EAPC) AND ANTIREFLUX SURGERY FOR TREATMENT OF BARRETT'S ESOPHAGUS. Harald Tigges, Karl H. Fuchs, Joern Maroske, Martin Fein, Arnulf Thiede, Dept of Surg, Univ of Wuerzburg, Wuerzburg, Germany.
Purpose: Since any division of anal sphincter muscle can result in varying degrees of fecal incontinence, the aim of this study was to determine if a new sphincter muscle-sparing technique using fibrin glue was effective in closing all types of anal fistulas. Methods: All patients with anal fistulas presenting to a single surgeon over a one year period were treated with fibrin glue. Six to eight weeks after drainage of any associated abscess and placement of a seton, the fistula tract(s) were debrided and then closed with either autologous fibrin glue or commercially available fibrin sealant. Results: Twenty fibrin glue fistula closures were performed in 17 consecutive patients. Etiology of the anal fistulas was anorectal suppurative disease in 11, Crohn' s disease in 4, suppurative disease plus HN in 1, and rectal cancer after local excision and radiation therapy in 1 patient. Median follow-up time was 7 months. Functional results have remained excellent with no patient reporting any change in continence after treatment. Fibrin glue closure of the anal fistula was successful in 13 patients (76%). In 3 of the 4 patients whose fistulas did not close, a second instillation of fibrin glue was successful in 2 cases for an overall anal fistula closure rate of 88% (15/17). The two patients that failed fibrin glue had complicated fistula disease associated with Crohn' s disease in one patient and numerous previous fistulotomies in the other patient. Conclusion: Fibrin glue is simple and effective treatment of all anal fistulas with excellent functional results. 3715 A PROSPECTIVE RANDOMIZED TRIAL OF TIPS VS SMALL DIAMETER PROSTHETIC H-GRAFT PORTACAVAL SHUNT IN THE TREATMENT OF BLEEDING VARICES. Al S. Rosemurgy, F. M. Serafini, T. Black, B. Zweibel, B. Kudryk, 1. H. Nord, S. B. Goode, Univ of South Florida, Tampa, FL. Objective: To determine the efficacy of TIPS vs 8 mm prosthetic H-graft portacaval shunt in the definitive treatment of bleeding varices due to portal hypertension through extended follow-up of our expanded randomized clinical trial. Methods: 132 consecutive patients were prospectively randomized to undergo TIPS or 8 mm prosthetic H-graft portacaval shunt (HGPCS). Both shunts were undertaken as definitive therapy. All patients had bleeding varices not amenable to or failing sclerotherapy/banding. Patients were excluded prior to randomization if chances for survival were hopeless. Failure of shunting was defined as technical inability to complete the shunt, irreversible shunt occlusion. major variceal rehemorrhage, hepatic failure leading to transplantation, or death. Data are reported as a mean z STD, when appropriate. Results: Follow up ranged from 1Yz to 6 Yz years, and averaged 4.0 years :!: 1.5 for TIPS and 3.9 years z 1.7 for HGPCS. (See Table 1) TIPS could not be placed in 2 patients. The postshunt portal vein - IVC pressure gradient was 9.0 mmHg :!: 4.1 after TIPS and 5.3 mmHg :!: 3.0 after HGPCS (p<0.05, Student's t-test). Periop deaths occured in 10 patients after TIPS and in 13 after HGPCS. To maintain shunt patency after TIPS there were 49 therapeutic interventions in 19 patients, while after HGPCS there were 6 interventions in 5 patients. After TIPS, 42 (64%) patients failed (experiencing 51 occurrences of failure), while 23 (35%) patients failed after HGPCS (experiencing 24 occurrences of failure). Shunt failure and interventions to maintain shunt patency were each significantly more frequent after TIPS (p<0.OO2, Fisher's Exact Test) (See Table 2) Conclusions: TIPS and HGPeS provide partial portal decompression, though portal pressures are lower after HGPCS. In the definitive management of portal hypertension, TIPS requires more interventions and is more frequently associated with shunt dysfunction, shunt failure, and hepatic failure. Despite vigilance in maintaining patency, TIPS provides less optimal outcomes than the 8 mm prosthetic H-graft portacaval shunts for patients with bleeding varices due to portal hypertension. Shunt
Number
Age (Years)
Cinflosis
Child's Ciass
TiPS HGPCS
66 66
55±12.5 54±13.0
70%ETOH 74% ETOH
12A, 258, 29C 9A, 248, 33C
Shunt
Rebieed
irreversibie Occlusion
Transplantation
Deaths
TIPS HGPCS
11 2'
4 2
5 0'
29 20
• Less than after TIPS, p
Purpose: Intestinal metaplasia in columnar lined epithelium of the esophagus is a premalignant condition. Neither medical nor surgical treatment proved substantial regression of Barrett's epithelium. Endoscopic argon plasma coagulation (EAPC) of the columnar lined epithelium in the esophagus is discussed controversial. The purpose of this pilot study was to evaluate the technical performance, the potential sideeffects and possible success regarding regression of Barrett's epithelium after EAPC and antireflux surgery. Methods: 30 patients with Barrett's esophagus were treated from August 1996 until December 1998. Regeneration of esophageal mucosa was achieved within several EAPCs. 24 h - hospitalization as well as treatment under general anesthesia was obligatory for these patients. All patients were on proton pump inhibitors. Endoscopic follow up was performed 4 - 6 weeks after the last session. Antireflux surgery (Nissen) was done after complete regeneration of squamous epithelium. One year after laparoscopic fundoplication and EAPC follow up with endoscopy and standardized quadrant biopsies of the esophagus, 24 h pH - measurement, and esophageal manometry was performed. Results: All 30 patients showed complete regeneration of squamous epithelium after median 3 (1 7) sessions of EAPC. 14 patients underwent I year follow up studies. All showed endoscopically a correct fundic wrap. In 2 patients Barrett's epithelium recurred without dysplasia again limited to a short segment of < I em. Corresponding to this findings these 2 patients showed recurrent acid reflux. Conclusions: Our results indicate that the combination of EAPC and antireflux surgery is an effective and safe treatment for gastroesophageal reflux disease. Long term follow up of this therapy is necessary to evaluate the patients benefit by regression of Barrett's epithelium in the majority of cases regarding cancer prevention. 3717 ENDOSCOPIC MANAGEMENT OF EARLY UPPER GASTROINTESTINAL INVASIVE CANCERS IN HIGH RISK PATIENTS. Neville Menezes, Chris 1. Shearer, C. Ross Carter, Robert C. Stuart, Glasgow Royal Infirmary, Glasgow, United Kingdom; Univ of Glasgow, Glasgow, United Kingdom. Background: Early upper GI malignancy is rare in Western populations. Although surgical resection offers the best prospects for cure, not all patients are fit to undergo major surgery due advanced age and co-morbid cardio-respiratory illness. Recent advances in endoscopic therapy may offer the chance of cure for some of these patients with early tumors, without the need for surgical resection. Aims: A retrospective evaluation of the endoscopic management of patients with early upper GI cancer, considered unsuitable for surgical resection on account of high risk due to co-morbid disease. Methods: Eighteen patients with early invasive upper GI tumors were treated endoscopically. All were ASA grade >3 . Median age was 74.5 years, range 68 - 96. There were 8 esophageal, 7 gastric and 3 duodenal lesions. Endoscopic Mucosal Resection (EMR) was performed in 10 patients. Laser therapy (Nd: YAG) was performed in 8 patients when the lesion was too extensive for EMR or associated with a wide field change effect. After EMR residual dysplasia or tumor (n=5) detected on biopsy at follow-up endoscopy was treated by laser therapy. The treatment sites were subsequently monitored endoscopically with biopsies performed at regular intervals. Results: At a median follow-up of 18 months (range, 1 - 44 months) complete endoscopic and pathological tumor ablation was seen in 14 patients with four patients currently undergoing further laser therapy. Of the 10 EMR patients 8 cancers were Tl and 2 involved the muscularis propria, T2. There was no mortality related to the endoscopic treatment and none of the patients have died of the tumor. Bleeding occurred in one patient after an EMR and two patients developed a perforation, one after an EMR and the other from laser treatment. All three patients had an uneventful recovery with conservative non-operative management. 2 patients developed an esophageal stricture after laser treatment which were amenable to balloon dilatation. Conclusion: In patients deemed unfit for major surgery, endoscopic treatment of early upper GI cancers appears to be an effective modality of treatment. EMR and laser therapy are useful complementary techniques particularly when dealing with large lesions associated with a wide field change.