Randomised Controlled Trial (Feasibility Study) of Prophylactic Pyloric Balloon Dilatation During Ivor Lewis Esophagectomy to Prevent Delayed Gastric Emptying
Mohamed Abdelrahman1*, Helen Neilens2, Victoria Yates2, Amber Lorde2, Arun Ariyarathenam1, Richard Berrisford1, Lee Humphreys1, Grant Sanders1, Tim Wheatley1 and David SY Chan1
1Department of Upper GI Surgery, Derriford Hospital, Plymouth, United Kingdom
2Department of Research and Development, Derriford Hospital, Plymouth, United Kingdom
*Corresponding Author: Mohamed Abdelrahman, Department of Upper GI Surgery, Derriford Hospital, Plymouth, United Kingdom.
Received:
May 08, 2023; Published:
July 12, 2023
Abstract
Early delayed gastric emptying (DGE) occurs in up to 37% of patients following esophagectomy. This can contribute to increased anastomotic leak and respiratory infection rates. Although the treatment of DGE in the form of pyloric balloon dilatation (PBD) post-operatively is well established, there is no consensus on the optimal approach in the prevention of DGE. The ultimate aim is to carry out a randomised control trial to determine the efficacy of prophylactic PBD in the prevention of DGE following esophagectomy. This manuscript details the protocol, recruitment strategy and potential timeline for a feasibility study addressing this. We detail the rationale, objectives, design and methods of this study. Patients will be recruited over a six-month period and randomised to either a control group (no intervention) or a treatment group (prophylactic PBD).
Keywords: Delayed Gastric Emptying (DGE); Pyloric Balloon Dilatation (PBD); Stomach
References
- I LEWIS. “The surgical treatment of carcinoma of the oesophagus; with special reference to a new operation for growths of the middle third”. British Journal of Surgery 34 (1946): 18-31.
- R Earlam and JR Cunha-Melo. “Oesophageal squamous cell carcinoma: I. A critical review of surgery”. British Journal of Surgery 67 (1980): 381-390.
- M Konradsson and M Nilsson. “Delayed emptying of the gastric conduit after esophagectomy”. The Journal of Thoracic Disease 11 (2019): S835-S844.
- A Deldycke., et al. “Functional outcome after Ivor Lewis esophagectomy for cancer”. Journal of Surgical Oncology 113 (2016): 24-28.
- M Konradsson., et al. “Diagnostic criteria and symptom grading for delayed gastric conduit emptying after esophagectomy for cancer: international expert consensus based on a modified Delphi process”. Diseases of the Esophagus 33 (2020): 1177.
- DN Lobo., et al. “Reproducibility and normal ranges for gastric emptying in normal volunteers using a test meal designed for post-operative patients”. Nuclear Medicine Communications 23 (2002): 97-101.
- F Benedix., et al. “Risk factors for delayed gastric emptying after esophagectomy”. Langenbeck's Archives of Surgery 402 (2017): 547-554.
- MKH Maus., et al. “Gastric Outlet Obstruction After Esophagectomy: Retrospective Analysis of the Effectiveness and Safety of Postoperative Endoscopic Pyloric Dilatation”. World Journal of Surgery 40 (2016): 2405-2411.
- JC Tham., et al. “Intraoperative pyloric botulinum toxin injection during Ivor-Lewis gastroesophagectomy to prevent delayed gastric emptying”. Diseases of the Esophagus 32 (2019): 1512.
- S Arya., et al. “The impact of pyloric drainage on clinical outcome following esophagectomy: a systematic review”. Diseases of the Esophagus 28 (2015): 326-335.
- RDL Akkerman., et al. “Long-term quality of life after oesophagectomy with gastric conduit interposition for cancer”. European Journal of Cancer 51 (2015): 1538-1545.
- E Hadzijusufovic., et al. “Preoperative endoscopic pyloric balloon dilatation decreases the rate of delayed gastric emptying after Ivor-Lewis esophagectomy”. Diseases of the Esophagus 32 (2019): 18.
- M Abdelrahman., et al. “Systematic review and meta-analysis of the influence of prophylactic pyloric balloon dilatation in the prevention of early delayed gastric emptying after oesophagectomy”. Diseases of the Esophagus (2021).
- EW Swanson., et al. “Endoscopic pyloric balloon dilatation obviates the need for pyloroplasty at esophagectomy”. Surgical Endoscopy 26 (2012): 2023-2028.
- C Decker., et al. “Gastric emptying after esophagectomy: comparing single therapy versus dual therapy method for pyloric drainage”. Shanghai Chest 4 (2020): 37-37.
Citation
Copyright