In the next of our ‘Paper of the Month’ series, we looked at 'Laparoscopic ileocaecal resection versus infliximab for terminal ileitis in Crohn's disease: a randomised controlled, open-label, multi centre trial' recently published in the Lancet Gastroenterology & Herpetology.
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What is known on the subject
Introduction of biological agents have changed the treatment algorithm of patients with ileocecal Crohn's disease when conventional medical treatment has failed. Generally, these patients are now offered biological agents as first choice and surgery only considered if patients have disease complications. However in the same period, the introduction of laparoscopic surgery has led to safer surgery with less influence on body image and cosmesis. These improvements in surgery combined with a considerable number of patients not responding to biological agents pose the question whether more patients should be offered surgery after conventional medical therapy fails? This hypothesis has been addressed by the international multi-center trial (LYRIC-trial).
What this study adds
Study design
Open randomised trial comparing laparoscopic ileocecal resection versus infliximab in patients with non stricturing ileocecal Crohn's disease (< 40 cm of involved ileum) and failure of conventional medical treatment.
Primary endpoint
Quality of life at 12 months measured by the Inflammatory Bowel Disease questionnaire (IBDQ).
Secondary endpoints
Numerous, including general quality of life, body image and cosmesis, morbidity and sick leave.
Patients
Between 2008 to 2015, 143 patients were included (73 patients received surgery and 70 infliximab)
Results
After 12 months, no significant difference was observed in the primary endpoint between the two groups. Further no major differences were seen in any of the secondary endpoints.
With a median observation of 4 years; 26 out of 70 pts (37%) in the infliximab group had a resection, while 19 out of 73 (26%) in the surgery group had received biological agents.
Author interpretation
Laparoscopic resection is a reasonable alternative to infliximab therapy in patients with non-stricturing ileocecal Crohn's disease after failure of conventional medical treatment.
Comments to the study
This is a well conducted randomized study concerning a very important clinical issue with a lack of evidence base. The paper is well written, describes in detail patients flow, data collection and provides a balanced discussion of strengths and limitations of the study. A major concern is, the few cases that were assessed for eligibility per year per centre (<1 person). This low number indicates that only a small fraction of potential candidates were assessed. This may be due to either gastroenterologist or patient preference. Hopefully cost benefit analysis and long-term follow up data will be published.
Implications for colorectal practice
This study should be carefully evaluated by medical gastroenterologists and colorectal surgeons that jointly manage patients with non-stricturing ileocecal Crohn's disease (< 40 cm of involved ileum) and failure of conventional medical treatment. It will only have a major impact if medical doctors, surgeons and patients consider resectional surgery as a reasonable alternative to biological agents.
Laparoscopic ileocaecal resection versus infliximab for terminal ileitis in Crohn's disease: a randomised controlled, open-label, multicentre trial. Lancet Gastroenterol Hepatol. 2017 Nov;2(11):785-792. doi: 10.1016/S2468-1253(17)30248-0. Epub 2017 Aug 31. Ponsioen CY1, de Groof EJ2, Eshuis EJ1, Gardenbroek TJ3, Bossuyt PMM4, Hart A5, Warusavitarne J6, Buskens CJ3, van Bodegraven AA7, Brink MA8, Consten ECJ9, van Wagensveld BA10, Rijk MCM11, Crolla RMPH12, Noomen CG13, Houdijk APJ14, Mallant RC15, Boom M16, Marsman WA17, Stockmann HB18, Mol B1, de Groof AJ1, Stokkers PC19, D'Haens GR1, Bemelman WA20; LIR!C study group.