The Safety and Efficiency of Stent-based Diverting Technique Versus Ileostomy in Rectal Cancer Patients
NCT ID: NCT06204497
Last Updated: 2024-01-12
Study Results
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Basic Information
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RECRUITING
NA
570 participants
INTERVENTIONAL
2024-01-31
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Stent-based Diverting Technique
For Stent-based Diverting Technique, the small intestine measuring 15 cm from the ileocecal junction was pulled out through the median incision in the lower abdomen. After a length-wise incision was established in the mesenteric margin of the small intestine, the degradable stent was implanted, and the intestine was sutured. Then, the stent was held in place using an external tie around the bowel. Next, a mushroom-like tube (28 Fr) was placed into the intestine proximal (5-10 cm) to the aforementioned stent. The other side of the mushroom-like tube was inserted through the right lower abdominal wall and connected with a drainage bag. An abdominal drainage tube, or an anal tube, if necessary, was inserted in the proper location prior to the closure of the incision and the abdominal cavity. Abdominal X-ray was routinely performed every week to detect stent degradation, and the mushroom-like tube (28 Fr) was removed two days after stent degradation.
Stent-based Diverting Technique
The stent-based diverting technique (SDT) contains two parts to achieve feces diversion One is a degradable solid intestinal stent to be implanted 20 cm from the terminal ileum and could be gradually degraded within 3-4 weeks. Another part is a drainage tube to be placed at the proximal 5-10 cm of the aforementioned stent. Given this SDT, intestinal contents could be diverted through the drainage tube, and the stent prevents the feces from entering the distal intestinal. After removing the drainage tube after 3-4 weeks, intestinal contents will freely access the distal intestinal space following the degradation of the stent. For patients, stoma reversal is avoided.
Ileostomy
There will be an ileostomy for the control group. An incision with a diameter of 2 cm will be performed in the lower abdomen, and layers will be separated into the abdominal cavity. The intestine, 20cm to the ileocecal juction under laparoscopic vision, will be pulled out. The anterior sheath of the rectus abdominis and the serous layer of the intestine will be sutured with an absorbable line. Then, the middle point of the mesangial margin of the intestine will be transected, and the intestine will be fixed on the skin. No volvulus or angular formation of the intestine should be confirmed laparoscopically.
Stent-based Diverting Technique
The stent-based diverting technique (SDT) contains two parts to achieve feces diversion One is a degradable solid intestinal stent to be implanted 20 cm from the terminal ileum and could be gradually degraded within 3-4 weeks. Another part is a drainage tube to be placed at the proximal 5-10 cm of the aforementioned stent. Given this SDT, intestinal contents could be diverted through the drainage tube, and the stent prevents the feces from entering the distal intestinal. After removing the drainage tube after 3-4 weeks, intestinal contents will freely access the distal intestinal space following the degradation of the stent. For patients, stoma reversal is avoided.
Interventions
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Stent-based Diverting Technique
The stent-based diverting technique (SDT) contains two parts to achieve feces diversion One is a degradable solid intestinal stent to be implanted 20 cm from the terminal ileum and could be gradually degraded within 3-4 weeks. Another part is a drainage tube to be placed at the proximal 5-10 cm of the aforementioned stent. Given this SDT, intestinal contents could be diverted through the drainage tube, and the stent prevents the feces from entering the distal intestinal. After removing the drainage tube after 3-4 weeks, intestinal contents will freely access the distal intestinal space following the degradation of the stent. For patients, stoma reversal is avoided.
Eligibility Criteria
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Inclusion Criteria
2. Rectal cancer patients with high-risk of anastomotic leakage(AL).
3. Age from over 18 to under 80 years.
4. Performance status of 0/1 on ECOG (Eastern Cooperative Oncology Group) scale.
5. ASA (American Society of Anesthesiology) score class I, II, or III.
6. Written informed consent.
Definition of high-risk of AL (one of them):
1. Preoperative body mass index (BMI) ≥30 kg/m2;
2. Long-term use of glucocorticoids before surgery (≥2 weeks);
3. Poor general condition: Preoperative serum albumin was less than 30.0g/L after supportive treatment; or Preoperative renal replacement therapy (blood purification/hemodialysis) is required; or diabetes;
4. Preoperative neoadjuvant radiotherapy;
5. Distance between tumor and anal anus (baseline MRI) ≤7cm
6. The number of stapler used to cut the rectum during the operation ≥3; or the defect of anastomosis is observed; or Intraoperative leak test was positive.
Exclusion Criteria
2. Familial Adenomatosis Polyposis Coli (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC), active Crohn's disease or active colitis ulcerosa.
3. History of unstable angina, myocardial infarction, cerebrovascular accident within the past six months.
4. Groups who are particularly vulnerable include those who suffer from mental disease, cognitive impairment, severe illness, adolescents, illiterates, women during pregnancy or breast-feeding, etc.
5. Patients with severe complications who do not tolerate surgery or need emergency surgery due to complication (bleeding, obstruction or perforation)
6. Unable ot radical resection, or underwent Miles or Hartmann or TaTME procedure, or requirement of simultaneous surgery for other disease (except the gallblader or appendix due to benign lesion).
18 Years
80 Years
ALL
No
Sponsors
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Sir Run Run Shaw Hospital
OTHER
Responsible Party
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Xiujun Cai
Director, Head of General Surgery, Principal Investigator, Clinical Professor
Principal Investigators
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XiuJun Cai, MD
Role: PRINCIPAL_INVESTIGATOR
Sir Run Run Shaw Hospital
Locations
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Beijing Friendship Hospital
Beijing, Beijing Municipality, China
Cancer Hospital, Peking University
Beijing, Beijing Municipality, China
Peking Union Hospital
Beijing, Beijing Municipality, China
Chinese PLA General Hospita
Beijing, Beijing Municipality, China
Fujian Union Hospital, Fujian Medical University
Fuzhou, Fujian, China
The First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Union Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, China
Xiangya Hospital, Central South Universit
Changsha, Hunan, China
The First Affiliated Hospital, Jilin University
Jilin, Jilin, China
Shengjing Hospital, China Medical University
Shenyang, Liaoning, China
The Affiliated Hospital, Qingdao University
Qingdao, Shandong, China
Cancer Hospital, Fudan University
Shanghai, Shanghai Municipality, China
ChangHai Hospital, The Second Military Medical University
Shanghai, Shanghai Municipality, China
Sichuan Cancer Hospital, University of Electronic Science and Technology of China
Chengdu, Sichuan, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Sir Run Run Shaw Hospital, Zhejiang University
Hangzhou, Zhejiang, China
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital, Ningbo University
Ningbo, Zhejiang, China
The Second Affiliated Hospital, Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Hongwei Yao, MD
Role: backup
Peng Zhang, MD
Role: backup
References
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Bonjer HJ, Deijen CL, Abis GA, Cuesta MA, van der Pas MH, de Lange-de Klerk ES, Lacy AM, Bemelman WA, Andersson J, Angenete E, Rosenberg J, Fuerst A, Haglind E; COLOR II Study Group. A randomized trial of laparoscopic versus open surgery for rectal cancer. N Engl J Med. 2015 Apr 2;372(14):1324-32. doi: 10.1056/NEJMoa1414882.
Sparreboom CL, van Groningen JT, Lingsma HF, Wouters MWJM, Menon AG, Kleinrensink GJ, Jeekel J, Lange JF; Dutch ColoRectal Audit group. Different Risk Factors for Early and Late Colorectal Anastomotic Leakage in a Nationwide Audit. Dis Colon Rectum. 2018 Nov;61(11):1258-1266. doi: 10.1097/DCR.0000000000001202.
Borstlap WAA, Westerduin E, Aukema TS, Bemelman WA, Tanis PJ; Dutch Snapshot Research Group. Anastomotic Leakage and Chronic Presacral Sinus Formation After Low Anterior Resection: Results From a Large Cross-sectional Study. Ann Surg. 2017 Nov;266(5):870-877. doi: 10.1097/SLA.0000000000002429.
Zhou S, Zhou H, Zheng Z, Liang J, Zhou Z, Wang X. Predictive risk factors for anastomotic leakage after anterior resection of rectal cancer in elderly patients over 80 years old: an analysis of 288 consecutive patients. World J Surg Oncol. 2019 Jun 29;17(1):112. doi: 10.1186/s12957-019-1655-z.
Wu J, Lu AD, Zhang LP, Zuo YX, Jia YP. [Study of clinical outcome and prognosis in pediatric core binding factor-acute myeloid leukemia]. Zhonghua Xue Ye Xue Za Zhi. 2019 Jan 14;40(1):52-57. doi: 10.3760/cma.j.issn.0253-2727.2019.01.010. Chinese.
Chen H, Cai HK, Tang YH. An updated meta-analysis of transanal drainage tube for prevention of anastomotic leak in anterior resection for rectal cancer. Surg Oncol. 2018 Sep;27(3):333-340. doi: 10.1016/j.suronc.2018.05.018. Epub 2018 May 22.
Mrak K, Uranitsch S, Pedross F, Heuberger A, Klingler A, Jagoditsch M, Weihs D, Eberl T, Tschmelitsch J. Diverting ileostomy versus no diversion after low anterior resection for rectal cancer: A prospective, randomized, multicenter trial. Surgery. 2016 Apr;159(4):1129-39. doi: 10.1016/j.surg.2015.11.006. Epub 2015 Dec 17.
Rao S, Guren MG, Khan K, Brown G, Renehan AG, Steigen SE, Deutsch E, Martinelli E, Arnold D; ESMO Guidelines Committee. Electronic address: [email protected]. Anal cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up☆. Ann Oncol. 2021 Sep;32(9):1087-1100. doi: 10.1016/j.annonc.2021.06.015. Epub 2021 Jun 24. No abstract available.
Rahbari NN, Weitz J, Hohenberger W, Heald RJ, Moran B, Ulrich A, Holm T, Wong WD, Tiret E, Moriya Y, Laurberg S, den Dulk M, van de Velde C, Buchler MW. Definition and grading of anastomotic leakage following anterior resection of the rectum: a proposal by the International Study Group of Rectal Cancer. Surgery. 2010 Mar;147(3):339-51. doi: 10.1016/j.surg.2009.10.012. Epub 2009 Dec 11.
Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
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Other Identifiers
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SRRSH.SDT
Identifier Type: -
Identifier Source: org_study_id
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