LIR!CMust knowCD · Surgery
Laparoscopic ileocaecal resection versus infliximab for terminal ileitis in Crohn's disease: a randomised controlled, open-label, multicentre trial
Ponsioen CY, et al.
Lancet Gastroenterol Hepatol 2017 · PMID 28838644 (PubMed, opens in a new tab) · doi 10.1016/S2468-1253(17)30248-0 (full paper, opens in a new tab)
| Outcome | Resection (n=73) | Infliximab (n=70) | Difference (95% CI) |
|---|---|---|---|
| IBDQ at 12 months, mean (95% CI) (primary endpoint) | 178.1 (171.1–185.0) | 172.0 (164.3–179.6) | 6.1 (−4.2 to 16.4); P=0.25 |
| SF-36 total score, mean (95% CI) | 112.1 (108.0–116.2) | 106.5 (102.1–110.9) | 5.6 (−0.4 to 11.6) |
| SF-36 mental component, mean (95% CI) | 49.5 (47.0–52.1) | 46.1 (43.3–48.9) | 3.5 (−0.3 to 7.3) |
| Days of sick leave, mean (SD) | 3.4 (7.1) | 1.4 (4.7) | P<0.0001 |
| Unscheduled hospital admission | 13/73 (18%) | 15/70 (21%) | P=0.68 |
| Crossover during follow-up | 19/73 (26%) started anti-TNF | 26/70 (37%) had a resection | — |
Quality of life was no worse after surgery, and more than a third of the infliximab group went on to have a resection anyway.
Source: Ponsioen 2017, abstract (intention to treat). IBDQ means are corrected for baseline differences. Crossover is over a median 4 years of follow-up.
Structured abstract
BackgroundFor limited ileocaecal Crohn's disease that had failed conventional therapy, escalation to a biologic was the usual next step, and surgery was often held back for complications, although it can give good short- and long-term results.
MethodsRandomised controlled, open-label, multicentre trial (29 hospitals, Netherlands and UK). 143 patients. Primary endpoint: Inflammatory Bowel Disease Questionnaire (IBDQ) quality-of-life score at 12 months.
ResultsPrimary result. Mean IBDQ 178.1 (95% CI 171.1–185.0) after resection vs 172.0 (164.3–179.6) with infliximab; mean difference 6.1 points (95% CI −4.2 to 16.4); P=0.25.
Take-homeFor limited (40 cm or less), non-stricturing terminal ileal Crohn's disease that has failed conventional therapy, laparoscopic resection is a reasonable alternative to starting an anti-TNF.
| Patients | 143 |
|---|---|
| Population | Adults aged 18–80 with non-stricturing ileocaecal Crohn's disease, active terminal ileal disease no longer than 40 cm, and no response to at least 3 months of steroids, thiopurines or methotrexate. Abdominal abscess excluded. |
| Comparison | Laparoscopic ileocaecal resection vs infliximab |
| Drugs | infliximab |
| Classes | Anti-TNF, Surgery |
| Published | Ponsioen CY, et al. Lancet Gastroenterol Hepatol 2017;2:785–92. |
Key points
- Sick leave was longer after resection (3.4 vs 1.4 days; P<0.0001); unscheduled admissions 18% vs 21% (P=0.68).
- Clavien-Dindo grade IIIa or worse surgical complications in 4 resection patients; treatment-related serious adverse events in 2 infliximab patients.
- Within a median 4 years, 37% (26/70) of the infliximab group had a resection and 26% (19/73) of the resection group started anti-TNF.
- Long-term follow-up (median 63.5 months): 48% (31/65) of the infliximab group had a resection; none of the resection group needed a second resection (PMID 32619413).
- 10-year follow-up (2026): therapy-free remission 35.8% after resection vs 13.2% with infliximab (difference 22.6%, 95% CI 7.8–36.8; P=0.0038); overall clinical remission similar (HR 0.79, 95% CI 0.52–1.20) (PMID 41724174).
Limitations
- Open-label and slow recruitment over 7 years; small sample.
- Infliximab was the only medical comparator; newer biologics and proactive drug monitoring were not tested.
- Long-term follow-ups were retrospective, and the age effect at 10 years is an exploratory interaction analysis.
Commentary
LIR!C changed the conversation about surgery in Crohn’s disease: an early ileocaecal resection is not a failure of medical therapy but an equal option for the right patient. ECCO guidance now lists resection as an alternative to biologics for limited ileocaecal disease.
The 10-year follow-up suggests younger patients may gain the most (estimated 10-year clinical remission 54% after resection vs 24% with infliximab at age 20), but this was exploratory. Discuss surgery early, with a colorectal surgeon, for patients with short-segment ileal disease, and plan postoperative monitoring as in POCER.
Journal club
Design
Randomised controlled, open-label, multicentre trial (29 hospitals, Netherlands and UK). 143 patients.
Primary result. Mean IBDQ 178.1 (95% CI 171.1–185.0) after resection vs 172.0 (164.3–179.6) with infliximab; mean difference 6.1 points (95% CI −4.2 to 16.4); P=0.25.
Validity and applicability
- Open-label and slow recruitment over 7 years; small sample.
- Infliximab was the only medical comparator; newer biologics and proactive drug monitoring were not tested.
- Long-term follow-ups were retrospective, and the age effect at 10 years is an exploratory interaction analysis.
Where it sits now
For limited (40 cm or less), non-stricturing terminal ileal Crohn's disease that has failed conventional therapy, laparoscopic resection is a reasonable alternative to starting an anti-TNF.
- POCER (2015): After resection, treating by risk and scoping at 6 months with step-up for recurrence beats drug prophylaxis alone; this is why we do a postoperative colonoscopy.
- REPREVIO (2025): Starting vedolizumab within 4 weeks of ileocolonic resection reduces early endoscopic recurrence in patients at risk.
- SPICY (2024): Removing more mesentery at primary ileocolic resection did not reduce 6-month endoscopic recurrence, and leaks were numerically more common.
- PREVENT (2016): In patients at increased risk, postoperative infliximab roughly halves endoscopic recurrence but did not significantly reduce clinical recurrence by week 76, so endoscopic monitoring is still needed.
Questions for discussion
- The primary endpoint was a quality-of-life score, not remission. Is that the right outcome for comparing surgery with a drug?
- Recruitment took 7 years. What does slow recruitment suggest about patient and surgeon preferences, and about who was enrolled?
- How would you present resection and an advanced therapy to a young patient with a short segment of terminal ileal disease today?