Does ESD equal TAMIS for early rectal neoplasms?
“ESD was associated with fewer technical constraints, higher procedural success, shorter hospitalization, lower cost, and greater patient acceptance."
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10/28/2025
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by Amy Pfeiffer
A multicenter randomized trial conducted in Spain has found that endoscopic submucosal dissection (ESD) is noninferior to transanal minimally invasive surgery (TAMIS) for the treatment of early rectal neoplasms, with comparable safety, shorter hospital stays, and substantially lower costs.
The DSETAMIS-2018 trial enrolled 73 patients with nonpedunculated early rectal neoplasms larger than 20 mm and stagedT1N0 or less. Participants were randomized to undergo either ESD (n=39) or TAMIS (n=34). The primary endpoint was 12-month local recurrence, while secondary outcomes evaluated technical success, complete (R0) and curative resection rates, procedure time, hospital stay, complications, and total cost.
At 12 months, local recurrence occurred in two patients treated with TAMIS and none treated with ESD. The absolute difference in recurrence risk was −6.7% which met the predefined noninferiority margin of 10%. Median hospital stay was one day for ESD versus two days for TAMIS, and mean procedure times were 140 minutes and 110 minutes, respectively. Both approaches demonstrated high technical success (100% for ESD vs 89% for TAMIS) and favorable safety profiles, with similar rates of early complications, according to the results published in Gastroenterology.
Late complications occurred in 29.6% of TAMIS cases compared with 16.3% of ESD cases, and readmission rates for late complications were higher in the TAMIS group (50%) than in the ESD group (14%). When margins were analyzed using expanded R0 criteria—accepting any tumor-free margin rather than over 1 mm—ESD achieved a complete resection rate of 93% compared with 67% for TAMIS. No cancer-related deaths were reported during a median follow-up of 15 months.
A cost analysis showed that TAMIS procedures were 83% to 103% more expensive than ESD, with median total costs of $13,135 vs $7,175, respectively.
The findings should be interpreted with caution given the small sample size and wide noninferiority margin, noted the authors led by Diego de Frutos Rosa, MD, (Hospital Universitario Puerta de Hierro in Madrid).
Still, the investigators wrote, “ESD was associated with fewer technical constraints, higher procedural success, shorter hospitalization, lower cost, and greater patient acceptance." They emphasized that while both ESD and TAMIS remain valid options, the results support the growing role of ESD in rectal lesion management within minimally invasive oncology.
Funding and author disclosures can be found in the published journal article.
Invited Commentary
Jérémie Jacques, MD, a professor of gastroenterology at Limoges University Hospital, France, provided the following commentary to GI & Hepatology News on the implications for first-line treatment of superficial rectal neoplasia based on the study findings.
Dr. Jacques: Given that ESD achieved similar oncologic outcomes with shorter hospital stays and lower overall costs than TAMIS, the implications for first-line management are substantial. The DSETAMIS randomized trial provides the first high-level, head-to-head evidence comparing ESD and TAMIS for early rectal neoplasms—and its results are difficult to overlook. When an endoscopic procedure achieves comparable oncologic efficacy, fewer complications, significantly shorter hospitalization, and dramatically lower costs, the rationale for routinely favoring a surgical approach weakens considerably.
Two additional multicenter studies—one French and one Dutch—presented at DDW 2025 and now under publication further reinforce the DSETAMIS findings. Both demonstrated similarly favorable outcomes for ESD, including significantly lower recurrence rates compared with TAMIS. When three independent cohorts across three countries converge on the same conclusion, it becomes increasingly difficult for centers to justify surgery as the default first-line option.
In Europe, this transition is already underway. Over recent years, many centers have progressively adopted ESD as the preferred first-line strategy for large superficial rectal tumors, driven by structured training programs and expanding operator experience. The DSETAMIS results therefore do not initiate this shift—they validate and accelerate a movement already in progress. These data should now encourage North American centers to follow suit, enabling patients to benefit from a minimally invasive, organ-sparing approach with proven effectiveness and substantially reduced resource utilization.
The study also suggests that ESD may expand the population eligible for minimally invasive therapy. A key observation from DSETAMIS is that all crossover cases were from TAMIS to ESD, illustrating how anatomical constraints—such as proximity to the dentate line, high rectal location, or circumferential extension—may limit TAMIS feasibility but do not impede ESD.
This aligns with everyday clinical experience: a considerable proportion of rectal lesions fall outside the optimal surgical workspace yet remain entirely suitable for endoscopic resection.
When performed by operators with fully mastered expertise, rectal ESD has virtually no technical limitations, regardless of lesion size, circumferential involvement, or anatomical position—from the anal canal transition to the rectosigmoid junction—so long as indications for superficial neoplasia are respected. This represents a major distinction from TAMIS, whose safety and feasibility depend heavily on exposure, access, and working space.
Moreover, ESD has now clearly emerged as the technique of choice for all rectal polyps over 2 cm. One of the most critical and often underappreciated steps remains appropriate confirmation of indication. No superficial-appearing rectal lesion should be referred for surgery without dedicated evaluation by an ESD-trained endoscopist, ideally supported by high-quality photo documentation. This simple but essential safeguard helps prevent overtreatment and avoids unnecessary rectal surgery.
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The guidelines emphasize four-hour gastric emptying studies over two-hour testing. How do you see this affecting diagnostic workflows in practice?
Dr. Staller: Moving to a four-hour solid-meal scintigraphy will actually simplify decision-making. The two-hour reads miss a meaningful proportion of delayed emptying; standardizing on four hours reduces false negatives and the “maybe gastroparesis” purgatory that leads to repeat testing. Practically, it means closer coordination with nuclear medicine (longer slots, consistent standardized meal), updating order sets to default to a four-hour protocol, and educating front-line teams so patients arrive appropriately prepped. The payoff is fewer equivocal studies and more confident treatment plans.
Metoclopramide and erythromycin are the only agents conditionally recommended for initial therapy. How does this align with what is being currently prescribed?
Dr. Staller: This largely mirrors real-world practice. Metoclopramide remains the only FDA-approved prokinetic for gastroparesis, and short “pulsed” erythromycin courses are familiar to many of us—recognizing tachyphylaxis limits durability. Our recommendation is “conditional” because the underlying evidence is modest and patient responses are heterogeneous, but it formalizes what many clinicians already do: start with metoclopramide (lowest effective dose, limited duration, counsel on neurologic adverse effects) and reserve erythromycin for targeted use (exacerbations, bridging).
Several agents, including domperidone and prucalopride, received recommendations against first-line use. How will that influence discussions with patients who ask about these therapies?
Dr. Staller: Two points I share with patients: evidence and access/safety. For domperidone, the data quality is mixed, and US access is through an FDA IND mechanism; you’re committing patients to EKG monitoring and a non-trivial administrative lift. For prucalopride, the gastroparesis-specific evidence isn’t strong enough yet to justify first-line use. So, our stance is not “never,” it’s just “not first.” If someone fails or cannot tolerate initial therapy, we can revisit these options through shared decision-making, setting expectations about benefit, monitoring, and off-label use. The guideline language helps clinicians have a transparent, evidence-based conversation at the first visit.
The guidelines suggest reserving procedures like G-POEM and gastric electrical stimulation for refractory cases. In your practice, how do you decide when a patient is “refractory” to medical therapy?
Dr. Staller: I define “refractory” with three anchors.
1. Adequate trials of foundational care: dietary optimization and glycemic control; an antiemetic; and at least one prokinetic at appropriate dose/duration (with intolerance documented if stopped early).
2. Persistent, function-limiting symptoms: ongoing nausea/vomiting, weight loss, dehydration, ER visits/hospitalizations, or malnutrition despite the above—ideally tracked with a validated instrument (e.g., GCSI) plus nutritional metrics.
3. Objective correlation: delayed emptying on a standardized 4-hour solid-meal study that aligns with the clinical picture (and medications that slow emptying addressed).
At that point, referral to a center with procedural expertise for G-POEM or consideration of gastric electrical stimulation becomes appropriate, with multidisciplinary evaluation (GI, nutrition, psychology, and, when needed, surgery).
What role do you see dietary modification and glycemic control playing alongside pharmacologic therapy in light of these recommendations?
Dr. Staller: They’re the bedrock. A small-particle, lower-fat, calorie-dense diet—often leaning on nutrient-rich liquids—can meaningfully reduce symptom burden. Partnering with dietitians early pays dividends. For diabetes, tighter glycemic control can improve gastric emptying and symptoms; I explicitly review medications that can slow emptying (e.g., opioids; consider timing/necessity of GLP-1 receptor agonists) and encourage continuous glucose monitor-informed adjustments. Pharmacotherapy sits on top of those pillars; without them, medications will likely underperform.
The guideline notes “considerable unmet need” in gastroparesis treatment. Where do you think future therapies or research are most urgently needed?
Dr. Staller: I see three major areas.
1. Truly durable prokinetics: agents that improve emptying and symptoms over months, with better safety than legacy options (e.g., next-gen motilin/ghrelin agonists, better-studied 5-HT4 strategies).
2. Endotyping and biomarkers: we need to stop treating all gastroparesis as one disease. Clinical, physiologic, and microbiome/omic signatures that predict who benefits from which therapy (drug vs G-POEM vs GES) would transform care.
3. Patient-centered trials: larger, longer RCTs that prioritize validated symptom and quality-of-life outcomes, include nutritional endpoints, and reflect real-world medication confounders.
Our guideline intentionally highlights these gaps to hopefully catalyze better trials and smarter referral pathways.
Dr. Staller is with the Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston.