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Full-thickness Resection in the Colon – Finally ?

Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands

GUT, 2017 Aug 10 [Epub ahead of print]

ORIGINAL ARTICLE
Colonoscopic full-thickness resection using an over-the-scope device: a prospective multicentre study in various indications
Arthur Schmidt1,2, Torsten Beyna3, Brigitte Schumacher4, Alexander Meining5, Hans-Juergen Richter-Schrag2, Helmut Messmann6, Horst Neuhaus3, David Albers4, Michael Birk5, Robert Thimme2, Andreas Probst6, Martin Faehndrich7, Thomas Frieling8, Martin Goetz9, Bettina Riecken1, Karel Caca1

Objective

Endoscopic full-thickness resection (EFTR) is a novel treatment of colorectal lesions not amenable to conventional endoscopic resection. The aim of this prospective multicentre study was to assess the efficacy and safety of the full-thickness resection device.

Design

181 patients were recruited in 9 centres with the indication of difficult adenomas (non-lifting and/or at difficult locations), early cancers and subepithelial tumours (SET). Primary endpoint was complete en bloc and R0 resection.

Results

EFTR was technically successful in 89.5%, R0 resection rate was 76.9%. In 127 patients with difficult adenomas and benign histology, R0 resection rate was 77.7%. In 14 cases, lesions harboured unsuspected cancer, another 15 lesions were primarily known as cancers. Of these 29 cases, R0 resection was achieved in 72.4%; 8 further cases had deep submucosal infiltration >1000 μm. Therefore, curative resection could only be achieved in 13/29 (44.8%). In the subgroup with SET (n=23), R0 resection rate was 87.0%. In general, R0 resection rate was higher with lesions ≤2 cm vs >2 cm (81.2% vs 58.1%, p=0.0038). Adverse event rate was 9.9% with a 2.2% rate of emergency surgery. Three month follow-up was available from 154 cases and recurrent/residual tumour was evident in 15.3%.

Conclusion

EFTR has a reasonable technical efficacy especially in lesions ≤2 cm with acceptable complication rates. Curative resection rate for early cancers was too low to recommend its primary use in this indication. Further comparative studies have to show the clinical value and long-term outcome of EFTR in benign colorectal lesions.

 

What should you know about this paper

For clinical cases, endoscopic full-thickness resection (EFTR) was developed and first described by Suzuki and Ikeda1 in 2001. It was performed in three Japanese patients with rectal cancer and a duodenum cancer. It showed promising results combining safety, efficacy and minimal invasiveness. Since then it has been used for a variety of indications (GIST resection², fistula tract closure³, full thickness biopsies for GI motility disorders⁴) but mainly for the removal of difficult colorectal polyps due to for example non-lifting or difficult localization.

The aim of this multicenter, prospective study was to assess the efficacy and safety of EFTR in colorectal lesions which were too difficult to resect (safely) via the conventional EMR.

They included 181 patients. Lesions included:

  • in 79% colorectal adenomas with negative lifting sign (recurrent, incompletely resected or untreated) or difficult location (adenomas involving the appendiceal orifice or a diverticulum)
  • in 8.3% T1 carcinomas (R1 resected and treatment naïve)
  • and in 12.7% subepithelial colorectal tumors.

Primary endpoints were macroscopically en-bloc resection and a histological R0 resection with EFTR. An important secondary endpoint was whether a resection of all layers of the colonic wall was performed. Overall, en-bloc resection was reached in 90% of cases; however, histological R0 resection was lower; 77%. When conveyed to the clinical setting, only 42 patients would require surgery. The authors mention that a total of 20 patients were treated surgically in an adjuvant manner. All in all, a clinically significant decrease in this highly selected cohort of difficult colorectal lesions. Nevertheless, what catches the eye is the inverse correlation between the size of the lesion and the a priori probability of a R0 resection. Although the en-bloc resection percentage (and therefore the technical success) of lesions > 20mm is 79%, the risk of a histological R0 resection is much lower: 58%. To compare these results, a recent, prospective, Dutch study also assessed the safety and efficacy of an EFTR technique in difficult colorectal polyps ⁵. There is also a small, retrospective study from Italy⁶. En-bloc resection in the prospective study was 100%, full-thickness resection was seen in 92%, R0 resection was histologically achieved in 73% ⁵. With of course the side note that half of the EFTR concerned a resection of scar tissue of a R1/x resected malignant polyp. In these cases, a R0 resection meant no adenomatous or cancerous tissue observed. Importantly Backes et al.⁵ did not include lesions > 20mm, confirming that the R0 resection and en-bloc resection rate diminishes with increasing size. What furthermore catches the eye is the percentage of R1 resections in adenocarcinomas. 28% in this subgroup would require additional surgical therapy; indeed, the authors mention that in 11 patients R1 resections were adjuvantly surgically resected. Still, EFTR significantly reduced the need for surgery in this subgroup.

Perforation and bleeding risks in this study seem clinically acceptable; 3.3% and 2.2%, respectively. However, perforation risk is double the risk reported by a recent, large meta-analysis for large colorectal polyps (>20mm) removed by EMR was 1.5% ⁶. Moreover, this was a group with a higher perforation and bleeding risk (6.5%) given the mean polyp size of 33mm ⁶. So, although EFTR risk seems satisfactory low, one should realize that this technique is associated with a higher complication rate than conventional EMR. Additionally, more prospective studies are needed to asses these risks.

Finally, a significant proportion of difficult adenomas and T1 carcinomas were previously non-radically resected or attempted to resect. This will result in subepithelial scarring and contributes to non-lifting. Scarring also results in a smaller specimen volume in EFTR due to tissue stiffness resulting in not being able to pull the tissue into the cap ⁵. As a consequence, this will lead to a R1 resection.

Not pretreating potential EFTR lesions could result in increasing the number of R0 resections. Moreover, the authors mention that endoscopists should be trained one day before being able to use the EFTR technique. Logically, long-term exposure of gastroenterologists to this novel technique will also lead to better results.

Final conclusions

When indications are strictly followed (colorectal lesions <20mm, colonic GISTs with rectum localization excluded, realizing high R1 resection rate in T1 carcinomas), this novel technique could be a welcome new addition to the arsenal of endoscopists for polyp removal, making the step-up approach to surgery avoidable.

Pros

  • Overall and difficult adenoma en bloc resection rates were 90% and 92%, respectively. R0 resection rates for both groups were 77% and 78%.
  • Effective technique for GIST removal: 87% R0 resection.
  • Acceptable bleeding and perforation risks: 2.2 % and 3.3%, respectively.
  • Cecum intubation was not a problem with the FTER device.
  • Endoscopists should be trained for one day with the EFTR technique.

Contras

  • The bigger the lesions, the smaller the likelihood of success; 42% R1 resection for lesions > 20mm.
  • 28% of adenocarcinomas had a R1 resection; consider surgery in malignant polyps (especially when > 20mm) as primary treatment.
  • Only 67% full-thickness resection in rectum; re-consider EFTR for subepithelial tumors in the deeper rectum wall.

Beyond the scope; future use

We would also like to make a case for EFTR for pT1(a) esophageal adenocarcinoma, as en bloc endoscopic resection is sometimes difficult for these tumors. EMR is currently considered as the gold standard for early Barrett carcinoma’s ⁸, as it serves both a therapeutic (R0 resection of pT1a) and diagnostic (differentiating pT1a from pT1b and pT2) purpose. But this has proven to be difficult as often a piecemeal EMR resection is needed due to the size of the lesion, making it difficult to decide that resection was indeed macroscopically radical. Moreover, the lateral and vertical resection margins are difficult to assess by the pathologist due to piecemeal character of the resection and the use of electrocoagulation. To date, no case series, retrospective cohort studies, prospective trials or preferably randomized controlled trials (compared to EMR) have been published assessing EFTR in early esophageal cancers.

References

  1. Endoscopic mucosal resection and full thickness resection with complete defect closure for early gastrointestinal malignancies. Suzuki H1, Ikeda K. Endoscopy. 2001.
  2. Endoscopic Full-thickness Resection for Gastric Subepithelial Tumors Originating From the Muscularis Propria: A 69-Case Series. Sun M, Song J, Song X, Liu B. Surg Laparosc Endosc Percutan Tech. 2017.
  3. Endoscopic full-thickness resection of fistula tract with suture closure. Chiang AL, Storm AC, Aihara H, Thompson CC. Endoscopy. 2017.
  4. Diagnostic use of endoscopic full-thickness wall resection (eFTR)-a novel minimally invasive technique for colonic tissue sampling in patients with severe gastrointestinal motility disorders. Valli PV, Pohl D, Fried M, Caduff R, Bauerfeind P. Neurogastroenterol Motil. 2017.
  5. Colorectal endoscopic full-thickness resection using a novel, flat-base over-the-scope clip: a prospective study. Backes Y1, Kappelle WFW1, Berk L2, Koch AD3, Groen JN4, de Vos Tot Nederveen Cappel WH5, Schwartz MP6, Kerkhof M7, Siersema PD1, Schröder R8, Tan TG9, Lacle MM10, Vleggaar FP1, Moons LMG1; T1 CRC Working Group. Endoscopy. 2017.
  6. Endoscopic full-thickness resection of superficial colorectal neoplasms using a new over-the-scope clip system: A single-centre study. Andrisani G1, Pizzicannella M2, Martino M2, Rea R2, Pandolfi M2, Taffon C3, Caricato M4, Coppola R4, Crescenzi A3, Costamagna G5, Di Matteo FM2. Dig Liver Dis. 2017.
  7. Efficacy and safety of endoscopic resection of large colorectal polyps: a systematic review and meta-analysis. Hassan C, Repici A, Sharma P, et al. Gut 2016.
  8. ACG Clinical Guideline: Diagnosis and Management of Barrett’s Esophagus. Shaheen NJ1, Falk GW2, Iyer PG3, Gerson LB4; American College of Gastroenterology. Am J Gastroenterol. 2016. 

Dura P. 1, Siersema P.D. ²

  1. MD, PhD, Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands
  2. MD, PhD, Professor of Endoscopic Gastrointestinal Oncology, Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands
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