Mesentery Guide Identify Microscopic Clean Resection and Reduces Crohn's Endoscopic Recurrence

NCT ID: NCT06550843

Last Updated: 2024-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-01

Study Completion Date

2021-07-01

Brief Summary

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Microscopic clean margin is associated with reduced endoscopic recurrence after bowel resection for ileocolic Crohn's disease (CD). We aimed to investigate whether the extent of creeping fat could help indicate microscopic inflammation beyond naked eye assessment of the bowel wall and reduce endoscopic recurrence after ileocolic resection.

Detailed Description

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Despite proactive prophylactic treatment administered after surgery for Crohn's disease (CD) patients, early postoperative endoscopic recurrence (EPER) still occurs in 50-80% of patients within six months, increasing the risk of long-term clinical and surgical recurrence. Risk factors for EPER have already been identified, including active smoking, disease behavior, younger age, concomitant perianal disease, prior intestinal resections, and microscopic resection margin positivity. Recently, the influence of microscopic inflammation at the resection margin on EPER has been highlighted by various studies and meta-analysis.

From a surgical perspective, it has become common practice to conservatively resect 2cm width from the gross lesion to lower re-operation risks, while the optimal strategy to attain the microscopic clean margin and minimize EPER remain unclear, considering the limited accuracy of frozen-section examinations. More importantly, the diseased mucosa proximal to the ileal lesion can be healed by preoperative optimization, potentially concealing deeper lesions at the muscularis propria and serosal levels from visual assessment during surgery. Therefore, identifying a macroscopic marker that highly correlates with microscopic inflammation is essential to help locate the clean division.

As a hallmark of CD, the hyperplasia of mesenteric adipose tissue (MAT) or "Creeping fat," was found directly triggered by transmural inflammation and bacterial translocation from CD affected lumen11. Correspondingly, creeping fat has been found to correlate with macroscopic mucosal abnormalities observed after opening the bowel12. However, its relationship with microscopic inflammation, as well as its potential role in determining the division position to achieve better EPER outcomes, remains to be clarified.

Conditions

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Crohn Disease Recurrence

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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conventional group

In the conventional group, the cutting line was approximately 2cm proximal to the macroscopic lesion where the mucosa and intestinal wall appeared macroscopically normal, regardless of the adjacent mesentery.

No interventions assigned to this group

mesentery-guided group (Mes-G)

In the Mes-G group, all surgeries were performed by one surgeon team (J.K.) from January 2013 using the following strategy for the proximal division site: the diseased bowel and para-intestinal mesentery were carefully compared by palpation and translucent observation through a shadowless lamp. The comparison was conducted from the diseased bowel towards the normal-appearing region upstream, to identify a point where the hypertrophied mesentery transitioned into normal thickness and softness and became translucent as observed through the shadowless lamp.

mesentery-guided division

Intervention Type PROCEDURE

In the Mes-G group, all surgeries were performed by one surgeon team (J.K.) from January 2013 using the following strategy for the proximal division site: the diseased bowel and para-intestinal mesentery were carefully compared by palpation and translucent observation through a shadowless lamp. The comparison was conducted from the diseased bowel towards the normal-appearing region upstream, to identify a point where the hypertrophied mesentery transitioned into normal thickness and softness and became translucent as observed through the shadowless lamp.

Interventions

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mesentery-guided division

In the Mes-G group, all surgeries were performed by one surgeon team (J.K.) from January 2013 using the following strategy for the proximal division site: the diseased bowel and para-intestinal mesentery were carefully compared by palpation and translucent observation through a shadowless lamp. The comparison was conducted from the diseased bowel towards the normal-appearing region upstream, to identify a point where the hypertrophied mesentery transitioned into normal thickness and softness and became translucent as observed through the shadowless lamp.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Localized ileocolic CD

Exclusion Criteria

* Patients with a stoma,residuallesion ,history of bowel resection,or post-operative abdominalinfection were excluded
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Jia Ke

Ph.D

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Hammoudi N, Cazals-Hatem D, Auzolle C, Gardair C, Ngollo M, Bottois H, Nancey S, Pariente B, Buisson A, Treton X, Fumery M, Bezault M, Seksik P, Le Bourhis L; REMIND Study Group Investigators; Flejou JF, Allez M. Association Between Microscopic Lesions at Ileal Resection Margin and Recurrence After Surgery in Patients With Crohn's Disease. Clin Gastroenterol Hepatol. 2020 Jan;18(1):141-149.e2. doi: 10.1016/j.cgh.2019.04.045. Epub 2019 Apr 28.

Reference Type BACKGROUND
PMID: 31042575 (View on PubMed)

Tandon P, Malhi G, Abdali D, Pogue E, Marshall JK, de Buck van Overstraeten A, Riddell R, Narula N. Active Margins, Plexitis, and Granulomas Increase Postoperative Crohn's Recurrence: Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2021 Mar;19(3):451-462. doi: 10.1016/j.cgh.2020.08.014. Epub 2020 Aug 12.

Reference Type BACKGROUND
PMID: 32801016 (View on PubMed)

Poredska K, Kunovsky L, Marek F, Kala Z, Prochazka V, Dolina J, Zboril V, Kovalcikova P, Pavlik T, Jabandziev P, Pavlovsky Z, Vlazny J, Mitas L. The Influence of Microscopic Inflammation at Resection Margins on Early Postoperative Endoscopic Recurrence After Ileocaecal Resection for Crohn's Disease. J Crohns Colitis. 2020 Mar 13;14(3):361-368. doi: 10.1093/ecco-jcc/jjz153.

Reference Type BACKGROUND
PMID: 31501878 (View on PubMed)

Fazio VW, Marchetti F, Church M, Goldblum JR, Lavery C, Hull TL, Milsom JW, Strong SA, Oakley JR, Secic M. Effect of resection margins on the recurrence of Crohn's disease in the small bowel. A randomized controlled trial. Ann Surg. 1996 Oct;224(4):563-71; discussion 571-3. doi: 10.1097/00000658-199610000-00014.

Reference Type BACKGROUND
PMID: 8857860 (View on PubMed)

Muller JM, Keller HW, Erasmi H, Pichlmaier H. Total parenteral nutrition as the sole therapy in Crohn's disease--a prospective study. Br J Surg. 1983 Jan;70(1):40-3. doi: 10.1002/bjs.1800700116.

Reference Type RESULT
PMID: 6402050 (View on PubMed)

Regueiro M, Velayos F, Greer JB, Bougatsos C, Chou R, Sultan S, Singh S. American Gastroenterological Association Institute Technical Review on the Management of Crohn's Disease After Surgical Resection. Gastroenterology. 2017 Jan;152(1):277-295.e3. doi: 10.1053/j.gastro.2016.10.039. Epub 2016 Nov 10. No abstract available.

Reference Type RESULT
PMID: 27840073 (View on PubMed)

Panes J, Rimola J. Perianal fistulizing Crohn's disease: pathogenesis, diagnosis and therapy. Nat Rev Gastroenterol Hepatol. 2017 Nov;14(11):652-664. doi: 10.1038/nrgastro.2017.104. Epub 2017 Aug 9.

Reference Type RESULT
PMID: 28790453 (View on PubMed)

Other Identifiers

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Sixth Affiliated Hospital 001

Identifier Type: -

Identifier Source: org_study_id

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