Effectiveness of Methods for Pyloric Drainage in esophagecTomY: Botox vs. Pyloromyotomy
NCT ID: NCT06721520
Last Updated: 2025-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
170 participants
INTERVENTIONAL
2024-12-03
2028-05-31
Brief Summary
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Is intrapyloric Botox injection as a drainage procedure during esophagectomy non-inferior in preventing symptoms of delayed gastric emptying at 6 months postoperatively compared to pyloromyotomy?
Researchers will compare intrapyloric Botox injection to pyloromyotomy to see if Botox is non-inferior to pyloromyotomy in easing symptoms of delayed gastric emptying.
Participants will:
Be randomized to one of two treatment groups-either intrapyloric Botox injection or pyloromyotomy-during their esophagectomy.
Complete surveys assessing digestive symptoms at standard postoperative follow-up intervals (3 months, 6 months, 1 year, and 2 years postoperatively).
Undergo a standard gastric emptying study at 6 months after surgery.
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Detailed Description
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Patients randomized for intrapyloric Botox injection will undergo our standard procedure as follows: 100 units of Botox is dissolved in 10 mL normal saline. After identifying the pylorus during esophagectomy, 10 mL of the Botox solution is injected intramuscularly at the anterior pyloric ring in 2 separate areas and in 1 area on each side of the pyloric ring (total 4 areas). Patients randomized for pyloromyotomy will undergo standard pyloromyotomy through a transabdominal, anterior approach.
This study will occur at Cleveland Clinic Foundation in Cleveland, OH. Three staff surgeons will perform these operations.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Botox
Patients will be randomized to the intrapyloric Botox injection intervention arm intraoperatively just after the pylorus is identified and just prior to the time at which pyloric drainage would occur routinely, at which point it is feasible for the surgeon to perform either intervention.
Botulinum Toxin A (Botox )
Patients randomized for intrapyloric Botox injection will undergo the following standard procedure: 100 units of Botox are dissolved in 10 mL normal saline. After identifying the pylorus, the 10 mL of Botox solution is injected intramuscularly at the anterior pyloric ring in 2 separate areas and in 1 area on each side of the pyloric ring.
Pyloromyotomy
Patients will be randomized to the pyloromyotomy intervention arm intraoperatively just after the pylorus is identified and just prior to the time at which pyloric drainage would occur routinely, at which point it is feasible for the surgeon to perform either intervention.
Pyloromyotomy
Patients randomized for pyloromyotomy will undergo standard pyloromyotomy as follows: after identifying the pylorus, a 2-cm longitudinal incision is made with Metzenbaum or Mayo scissors on the anterior pylorus, centered on the pyloric ring. The incision extends through the serosa and muscular layers to expose the submucosa and mucosa, which is left intact. The cut muscle is spread apart until the submucosa bulges up to the level of the cut serosa. Care is taken to avoid perforation, and the surgeon confirms no mucosal perforation at the end of the procedure. If a perforation is encountered, it will be repaired primarily.
Interventions
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Botulinum Toxin A (Botox )
Patients randomized for intrapyloric Botox injection will undergo the following standard procedure: 100 units of Botox are dissolved in 10 mL normal saline. After identifying the pylorus, the 10 mL of Botox solution is injected intramuscularly at the anterior pyloric ring in 2 separate areas and in 1 area on each side of the pyloric ring.
Pyloromyotomy
Patients randomized for pyloromyotomy will undergo standard pyloromyotomy as follows: after identifying the pylorus, a 2-cm longitudinal incision is made with Metzenbaum or Mayo scissors on the anterior pylorus, centered on the pyloric ring. The incision extends through the serosa and muscular layers to expose the submucosa and mucosa, which is left intact. The cut muscle is spread apart until the submucosa bulges up to the level of the cut serosa. Care is taken to avoid perforation, and the surgeon confirms no mucosal perforation at the end of the procedure. If a perforation is encountered, it will be repaired primarily.
Eligibility Criteria
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Inclusion Criteria
* Undergoing elective esophagectomy (thoracoabdominal, Ivor-Lewis, McKeown)
* Receiving a gastric conduit for alimentary reconstruction
* Technically able to receive either intrapyloric Botox injection or pyloromyotomy as ultimately determined intraoperatively
* Willing and able to provide informed consent
* Willing and able to participate in long-term follow up including study visits and surveys
Exclusion Criteria
* Patients with underlying neuromuscular disease as Botox would be contraindicated (amyotrophic lateral sclerosis, myasthenia gravis, muscular dystrophies, Lambert-Eaton syndrome)
* Patients undergoing left thoracoabdominal without left cervical neck incision (i.e., Sweet esophagectomy) - excluded due to the extent of gastric resection
* Pregnancy
* Allergy or hypersensitivity to botulinum toxin
* Cannot feasibly receive both pyloric interventions as determined intraoperatively (e.g., patients with central obesity undergoing thoracoabdominal esophagectomy makes for a technically difficult pyloromyotomy)
18 Years
ALL
No
Sponsors
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The Cleveland Clinic
OTHER
Responsible Party
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Siva Raja
Principal Investigator
Principal Investigators
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Siva Raja, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Cleveland Clinic
Cleveland, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Khan OA, Manners J, Rengarajan A, Dunning J. Does pyloroplasty following esophagectomy improve early clinical outcomes? Interact Cardiovasc Thorac Surg. 2007 Apr;6(2):247-50. doi: 10.1510/icvts.2006.149500. Epub 2006 Dec 18.
Urschel JD, Blewett CJ, Young JE, Miller JD, Bennett WF. Pyloric drainage (pyloroplasty) or no drainage in gastric reconstruction after esophagectomy: a meta-analysis of randomized controlled trials. Dig Surg. 2002;19(3):160-4. doi: 10.1159/000064206.
Fok M, Cheng SW, Wong J. Pyloroplasty versus no drainage in gastric replacement of the esophagus. Am J Surg. 1991 Nov;162(5):447-52. doi: 10.1016/0002-9610(91)90258-f.
Deng B, Tan QY, Jiang YG, Zhao YP, Zhou JH, Chen GC, Wang RW. Prevention of early delayed gastric emptying after high-level esophagogastrostomy by "pyloric digital fracture". World J Surg. 2010 Dec;34(12):2837-43. doi: 10.1007/s00268-010-0766-z.
Arya S, Markar SR, Karthikesalingam A, Hanna GB. The impact of pyloric drainage on clinical outcome following esophagectomy: a systematic review. Dis Esophagus. 2015 May-Jun;28(4):326-35. doi: 10.1111/dote.12191. Epub 2014 Feb 24.
Sutcliffe RP, Forshaw MJ, Tandon R, Rohatgi A, Strauss DC, Botha AJ, Mason RC. Anastomotic strictures and delayed gastric emptying after esophagectomy: incidence, risk factors and management. Dis Esophagus. 2008;21(8):712-7. doi: 10.1111/j.1442-2050.2008.00865.x. Epub 2008 Oct 1.
Benedix F, Willems T, Kropf S, Schubert D, Stubs P, Wolff S. Risk factors for delayed gastric emptying after esophagectomy. Langenbecks Arch Surg. 2017 May;402(3):547-554. doi: 10.1007/s00423-017-1576-7. Epub 2017 Mar 21.
Hajibandeh S, Hajibandeh S, McKenna M, Jones W, Healy P, Witherspoon J, Blackshaw G, Lewis W, Foliaki A, Abdelrahman T. Effect of intraoperative botulinum toxin injection on delayed gastric emptying and need for endoscopic pyloric intervention following esophagectomy: a systematic review, meta-analysis, and meta-regression analysis. Dis Esophagus. 2023 Oct 27;36(11):doad053. doi: 10.1093/dote/doad053.
Konradsson M, Nilsson M. Delayed emptying of the gastric conduit after esophagectomy. J Thorac Dis. 2019 Apr;11(Suppl 5):S835-S844. doi: 10.21037/jtd.2018.11.80.
Tcherniak A, Kashtan DH, Melzer E. Successful treatment of gastroparesis following total esophagectomy using botulinum toxin. Endoscopy. 2006 Feb;38(2):196. doi: 10.1055/s-2006-925148. No abstract available.
Stewart CL, Wilson L, Hamm A, Bartsch C, Boniface M, Gleisner A, Mitchell JD, Weyant MJ, Meguid R, Gajdos C, Edil BH, McCarter M. Is Chemical Pyloroplasty Necessary for Minimally Invasive Esophagectomy? Ann Surg Oncol. 2017 May;24(5):1414-1418. doi: 10.1245/s10434-016-5742-x. Epub 2017 Jan 5.
Giugliano DN, Berger AC, Meidl H, Pucci MJ, Rosato EL, Keith SW, Evans NR, Palazzo F. Do intraoperative pyloric interventions predict the need for postoperative endoscopic interventions after minimally invasive esophagectomy? Dis Esophagus. 2017 Apr 1;30(4):1-8. doi: 10.1093/dote/dow034.
Tham JC, Nixon M, Ariyarathenam AV, Humphreys L, Berrisford R, Wheatley T, Sanders G. Intraoperative pyloric botulinum toxin injection during Ivor-Lewis gastroesophagectomy to prevent delayed gastric emptying. Dis Esophagus. 2019 Jun 1;32(6):doy112. doi: 10.1093/dote/doy112.
Cerfolio RJ, Bryant AS, Canon CL, Dhawan R, Eloubeidi MA. Is botulinum toxin injection of the pylorus during Ivor Lewis [corrected] esophagogastrectomy the optimal drainage strategy? J Thorac Cardiovasc Surg. 2009 Mar;137(3):565-72. doi: 10.1016/j.jtcvs.2008.08.049.
Martin JT, Federico JA, McKelvey AA, Kent MS, Fabian T. Prevention of delayed gastric emptying after esophagectomy: a single center's experience with botulinum toxin. Ann Thorac Surg. 2009 Jun;87(6):1708-13; discussion 1713-4. doi: 10.1016/j.athoracsur.2009.01.075.
Bagheri R, Fattahi SH, Haghi SZ, Aryana K, Aryanniya A, Akhlaghi S, Riyabi FN, Sheibani S. Botulinum toxin for prevention of delayed gastric emptying after esophagectomy. Asian Cardiovasc Thorac Ann. 2013 Dec;21(6):689-92. doi: 10.1177/0218492312468438. Epub 2013 Jul 11.
Eldaif SM, Lee R, Adams KN, Kilgo PD, Gruszynski MA, Force SD, Pickens A, Fernandez FG, Luu TD, Miller DL. Intrapyloric botulinum injection increases postoperative esophagectomy complications. Ann Thorac Surg. 2014 Jun;97(6):1959-64; discussion 1964-5. doi: 10.1016/j.athoracsur.2013.11.026. Epub 2014 May 1.
Marchese S, Qureshi YA, Hafiz SP, Dawas K, Turner P, Mughal MM, Mohammadi B. Intraoperative Pyloric Interventions during Oesophagectomy: a Multicentre Study. J Gastrointest Surg. 2018 Aug;22(8):1319-1324. doi: 10.1007/s11605-018-3759-0. Epub 2018 Apr 17.
Fuchs HF, Broderick RC, Harnsberger CR, Divo FA, Coker AM, Jacobsen GR, Sandler BJ, Bouvet M, Horgan S. Intraoperative Endoscopic Botox Injection During Total Esophagectomy Prevents the Need for Pyloromyotomy or Dilatation. J Laparoendosc Adv Surg Tech A. 2016 Jun;26(6):433-8. doi: 10.1089/lap.2015.0575. Epub 2016 Apr 4.
Kent MS, Pennathur A, Fabian T, McKelvey A, Schuchert MJ, Luketich JD, Landreneau RJ. A pilot study of botulinum toxin injection for the treatment of delayed gastric emptying following esophagectomy. Surg Endosc. 2007 May;21(5):754-7. doi: 10.1007/s00464-007-9225-9. Epub 2007 Feb 16.
Other Identifiers
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24-898
Identifier Type: -
Identifier Source: org_study_id
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