Evaluating Acid Reflux After Oesophageal Stenting Using Anti-reflux Stents

NCT05303298 | Unknown

• 1 other identifier: HREC REF NO: 706/2021
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Incurable oesophageal cancer remains a global problem and in South Africa the vast majority of patients with oesophageal cancer have advanced disease at first presentation and are not curable. Likely the most distressing symptom of advanced cancer in the oesophagus is dysphagia, which is the inability to swallow solids and later also liquids. This is successfully addressed in most cases by the placement of a stent in the oesophagus which opens the area of obstruction. When placed in the lower oesophagus, one of the major drawbacks of these stents is that they disrupt the anti-reflux mechanism of the oesophago-gastric junction, which can result in severe acid reflux, severely impacting the quality of life of the patient. To address this problem, a range of approved anti-reflux stents have been developed and tested in numerous trials. To date, the evidence is conflicting and there is insufficient current evidence to support the routine use of these stents. However, the trials are not all similar in how the acid reflux was measured or what type of stent was used. Furthermore, the use of anti-reflux medication, such as proton pump inhibitors, which may help reduce reflux, are not standardised across the trials and make further conclusions about these stents difficult to interpret. No data from Sub-Saharan Africa on the use of anti-reflux stents in these patients is available. South Africa faces a large burden of incurable oesophageal cancer and improving the quality of life of these patients is of paramount importance. This randomised controlled trial aims to investigate whether anti-reflux stents do indeed reduce acid reflux in patients with incurable oesophageal cancer compared to conventional oesophageal stents that do not have such an anti-reflux mechanism. Reflux will be measured using patient questionnaires about reflux, and other quality of life parameters, and will also be objectively measured using oesophageal scintigraphy, which has not been used in previous similar trials.

Conditions

Esophageal Cancer; Reflux, Gastroesophageal

Keywords

Esophageal Cancer; Palliative Stenting; Gastroesophageal Reflux; Anti-reflux Stents

Outcome Measures

Primary Outcomes (2)

• Subjective gastro-oesophageal reflux (GOR) - change in GOR over specified time periods

  Self-reported symptomatic reflux using a validated reflux patient questionnaire - the GerdQ questionnaire. GerdQ: score ranges from 0 - 18 points with higher scores equating to higher GOR rates.

  Will be assessed pre-intervention and then at 1, 2, 4, and 8 weeks post intervention

• Objective gastro-oesophageal reflux (GOR)

  Objective measure of GOR will be done using oesophageal scintigraphy

  Will be performed as a once-off investigation on day 1 post stenting

Secondary Outcomes (5)

• Dysphagia - change in dysphagia over specified time periods

  Will be assessed pre-intervention and then at 1, 2, 4, and 8 weeks post intervention

• Pain - Change in pain over specified time periods

  Will be assessed pre-intervention and then at 1, 2, 4, and 8 weeks post intervention

• Cough - change in pain over specified time periods

  Will be assessed pre-intervention and then at 1, 2, 4, and 8 weeks post intervention

• Stent-related complications

  Documentation will occur at the time of stent insertion, day 1 post insertion and then at scheduled follow-ups at weeks 1, 2, 4 and 8 post-insertion or aat any time during the study period if a stent-related complication is reported

• Survival

  Documented at 8 weeks post stent insertion

Study Arms (2)

Anti-reflux Oesophageal Stent Group (AOSG)

EXPERIMENTAL

All patients randomised to this arm will receive an anti-reflux fully covered self-expanding metal oesophageal stent

Device: Anti-reflux oesophageal stent

Conventional Oesophageal Stent Group (COSG)

ACTIVE COMPARATOR

All patients randomised to this arm will receive a conventional fully covered self-expanding metal oesophageal stent that does not contain an anti-reflux mechanism

Device: Conventional oesophageal stent

Interventions

Anti-reflux oesophageal stent DEVICE

Fully covered self-expanding metal stent with anti-reflux mechanism

Anti-reflux Oesophageal Stent Group (AOSG)

Conventional oesophageal stent DEVICE

Fully covered self-expanding metal stent without an anti-reflux mechanism

Conventional Oesophageal Stent Group (COSG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients - 18 years of age or older
• Informed consent obtained from the patient after oral and written explanation of the trial
• Histologically confirmed malignancy of the distal oesophagus or OGJ
• Obstructive or irresectable malignancy due to metastases, local tumour infiltration or poor performance status
• Once deployed, the distal end of the stent must have crossed the OGJ junction and be lying within the proximal stomach

You may not qualify if:

• Patient declining or unable to give informed consent, including inability to speak or understand either English, Afrikaans or isiXhosa (the three most commonly spoken local languages).
• Patient unable to comply with the follow-up protocol of the trial (e.g. does not have a contactable telephone number)
• Oesophageal cancers selected for curative treatment or irresectable oesophageal cancers selected for palliative chemoradiation, but not requiring oesophageal stenting
• Benign oesophageal pathology or extrinsic compression of the oesophagus from another cause
• Patients with oesophageal cancers where the stent does not cross the OGJ
• Pregnant patients
• Patient performance status precluding any intervention or sedation

Sponsors & Collaborators

• University of Cape Town: lead

Study Sites (1)

University of Cape Town

Cape Town, Western Cape, 7925, South Africa

RECRUITING

Related Publications (17)

• Pandit S, Samant H, Morris J, Alexander SJ. Efficacy and safety of standard and anti-reflux self-expanding metal stent: A systematic review and meta-analysis of randomized controlled trials. World J Gastrointest Endosc. 2019 Apr 16;11(4):271-280. doi: 10.4253/wjge.v11.i4.271.

  PMID: 31040888 BACKGROUND

• Ferndale L, Sartorius B, Aldous C, Thomson SR. Oesophageal cancer in Area 2 of Kwazulu-Natal: predictors of late presentation. S Afr J Surg. 2019 Jun;57(2):4-9.

  PMID: 31342677 BACKGROUND

• Nel D, Omar M, Chinnery G, Jonas E. Disparity in oesophageal cancer management in South Africa: a comparison between two tertiary centres with special focus on the palliation of dysphagia. S Afr J Surg. 2019 Jun;57(2):10-15.

  PMID: 31342678 BACKGROUND

• Ferndale L, Aldous C, Hift R, Thomson S. Gender Differences in Oesophageal Squamous Cell Carcinoma in a South African Tertiary Hospital. Int J Environ Res Public Health. 2020 Sep 28;17(19):7086. doi: 10.3390/ijerph17197086.

  PMID: 32998198 BACKGROUND

• Dandara C, Robertson B, Dzobo K, Moodley L, Parker MI. Patient and tumour characteristics as prognostic markers for oesophageal cancer: a retrospective analysis of a cohort of patients at Groote Schuur Hospital. Eur J Cardiothorac Surg. 2016 Feb;49(2):629-34. doi: 10.1093/ejcts/ezv135. Epub 2015 Apr 12.

  PMID: 25870217 BACKGROUND

• Dua KS, DeWitt JM, Kessler WR, Diehl DL, Draganov PV, Wagh MS, Kahaleh M, Wong Kee Song LM, Khara HS, Khan AH, Aburajab MM, Ballard D, Forsmark CE, Edmundowicz SA, Brauer BC, Tyberg A, Buttar NS, Adler DG. A phase III, multicenter, prospective, single-blinded, noninferiority, randomized controlled trial on the performance of a novel esophageal stent with an antireflux valve (with video). Gastrointest Endosc. 2019 Jul;90(1):64-74.e3. doi: 10.1016/j.gie.2019.01.013. Epub 2019 Jan 23.

  PMID: 30684601 BACKGROUND

• Jones R, Junghard O, Dent J, Vakil N, Halling K, Wernersson B, Lind T. Development of the GerdQ, a tool for the diagnosis and management of gastro-oesophageal reflux disease in primary care. Aliment Pharmacol Ther. 2009 Nov 15;30(10):1030-8. doi: 10.1111/j.1365-2036.2009.04142.x. Epub 2009 Sep 8.

  PMID: 19737151 BACKGROUND

• Blomberg J, Wenger U, Lagergren J, Arnelo U, Agustsson T, Johnsson E, Toth E, Lagergren P. Antireflux stent versus conventional stent in the palliation of distal esophageal cancer. A randomized, multicenter clinical trial. Scand J Gastroenterol. 2010;45(2):208-16. doi: 10.3109/00365520903443860.

  PMID: 19968614 BACKGROUND

• Coron E, David G, Lecleire S, Jacques J, Le Sidaner A, Barrioz T, Coumaros D, Volteau C, Vedrenne B, Bichard P, Boustiere C, Touchefeu Y, Bregeon J, Prat F, Le Rhun M; Societe Francaise d'Endoscopie Digestive (SFED). Antireflux versus conventional self-expanding metallic Stents (SEMS) for distal esophageal cancer: results of a multicenter randomized trial. Endosc Int Open. 2016 Jun;4(6):E730-6. doi: 10.1055/s-0042-106960.

  PMID: 27556085 BACKGROUND

• Shim CS, Jung IS, Cheon YK, Ryu CB, Hong SJ, Kim JO, Cho JY, Lee JS, Lee MS, Kim BS. Management of malignant stricture of the esophagogastric junction with a newly designed self-expanding metal stent with an antireflux mechanism. Endoscopy. 2005 Apr;37(4):335-9. doi: 10.1055/s-2005-861113.

  PMID: 15824943 BACKGROUND

• Sabharwal T, Gulati MS, Fotiadis N, Dourado R, Botha A, Mason R, Adam A. Randomised comparison of the FerX Ella antireflux stent and the ultraflex stent: proton pump inhibitor combination for prevention of post-stent reflux in patients with esophageal carcinoma involving the esophago-gastric junction. J Gastroenterol Hepatol. 2008 May;23(5):723-8. doi: 10.1111/j.1440-1746.2008.05396.x.

  PMID: 18410607 BACKGROUND

• Power C, Byrne PJ, Lim K, Ravi N, Moore J, Fitzgerald T, Keeling PW, Reynolds JV. Superiority of anti-reflux stent compared with conventional stents in the palliative management of patients with cancer of the lower esophagus and esophago-gastric junction: results of a randomized clinical trial. Dis Esophagus. 2007;20(6):466-70. doi: 10.1111/j.1442-2050.2007.00696.x.

  PMID: 17958720 BACKGROUND

• Homs MY, Wahab PJ, Kuipers EJ, Steyerberg EW, Grool TA, Haringsma J, Siersema PD. Esophageal stents with antireflux valve for tumors of the distal esophagus and gastric cardia: a randomized trial. Gastrointest Endosc. 2004 Nov;60(5):695-702. doi: 10.1016/s0016-5107(04)02047-4.

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  PMID: 25085579 BACKGROUND

• Lai K. Chinese National Guidelines on Diagnosis and Management of Cough: consensus and controversy. J Thorac Dis. 2014 Oct;6(Suppl 7):S683-8. doi: 10.3978/j.issn.2072-1439.2014.10.06. No abstract available.

  PMID: 25383201 BACKGROUND

• Maurer AH, Parkman HP. Update on gastrointestinal scintigraphy. Semin Nucl Med. 2006 Apr;36(2):110-8. doi: 10.1053/j.semnuclmed.2005.12.003.

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• Falk GL, Beattie J, Ing A, Falk SE, Magee M, Burton L, Van der Wall H. Scintigraphy in laryngopharyngeal and gastroesophageal reflux disease: a definitive diagnostic test? World J Gastroenterol. 2015 Mar 28;21(12):3619-27. doi: 10.3748/wjg.v21.i12.3619.

  PMID: 25834329 BACKGROUND

MeSH Terms

Conditions

Esophageal Neoplasms; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders

Study Officials

• Matthias F Scriba, FCS (SA)

  University of Cape Town

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthias F Scriba, FCS (SA)

CONTACT

+27 82 295 2611; matthias.scriba@gmail.com

Galya E Chinnery, Gastroent

CONTACT

+27 21 404 2334; galya.chinnery@uct.ac.za

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will remain unaware of which type of stent they have received. Follow-up will be performed telephonically and the Outcomes Assessor will also remain blinded as to what type of stent the participant received
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Registrar: Upper Gastrointestinal Surgery, Surgical Gastroenterology, Department of Surgery

Model Details: Participants will be randomised to receive either an anti-reflux oesophageal stent or a conventional oesophageal stent.

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 31, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available immediately after publication of the study and for 5 years after this.
• Access Criteria: The study and proposed use of the data must be approved by an independent review committee identified for this purpose. Proposals should be directed to matthias.scriba@gmail.com. to gain access, data requestors will need to sign a data access agreement. Requests will be assessed by the study's Primary Investigator (PI) and the Study Sponsor, the University of Cape Town.

Locations

ZA (1)