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Rectal NeoplasmsNCT06204497

The Safety and Efficiency of Stent-based Diverting Technique Versus Ileostomy in Rectal Cancer Patients

A study testing Stent-based Diverting Technique in people with Rectal Neoplasms, run by Sir Run Run Shaw Hospital at 20 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial is to evaluate the safety and efficiency of stent-based tiverting technique (SDT) versus ileostomy in rectal cancer patients. After the removal of the rectal tumor, participants who are at high risk for anastomotic leakage will either undergo SDT or ileostomies. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Rectal Neoplasms
What is being tested?
Stent-based Diverting Technique
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
570 participants
Where
20 sitesChina
Study dates
31 Jan 2024to 28 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Rectal adenocarcinoma confirmed pathologically.
  • Rectal cancer patients with high-risk of anastomotic leakage(AL).
  • Age from over 18 to under 80 years.
  • Performance status of 0/1 on ECOG (Eastern Cooperative Oncology Group) scale.
  • ASA (American Society of Anesthesiology) score class I, II, or III.
  • Written informed consent.
Show all 13Show fewer
  • Definition of high-risk of AL (one of them):
  • Preoperative body mass index (BMI) ≥30 kg/m2;
  • Long-term use of glucocorticoids before surgery (≥2 weeks);
  • 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;
  • Preoperative neoadjuvant radiotherapy;
  • Distance between tumor and anal anus (baseline MRI) ≤7cm
  • 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.

Who cannot join

  • History of previous rectectomy, except endoscopic mucosal resection or endoscopic submucosal dissection.
  • Familial Adenomatosis Polyposis Coli (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC), active Crohn's disease or active colitis ulcerosa.
  • History of unstable angina, myocardial infarction, cerebrovascular accident within the past six months.
  • 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.
  • Patients with severe complications who do not tolerate surgery or need emergency surgery due to complication (bleeding, obstruction or perforation)
  • 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).

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

China20 sites

  • Beijing Friendship Hospital

    Beijing, Beijing Municipality, 100000

  • Cancer Hospital, Peking University

    Beijing, Beijing Municipality, 100000

  • Peking Union Hospital

    Beijing, Beijing Municipality, 100000

  • Chinese PLA General Hospita

    Beijing, Beijing Municipality, 310000

  • Xiangya Hospital, Central South Universit

    Changsha, Hunan, 410000

  • Sichuan Cancer Hospital, University of Electronic Science and Technology of China

    Chengdu, Sichuan, 610000

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610000

  • Fujian Union Hospital, Fujian Medical University

    Fuzhou, Fujian, 350000

  • The First Affiliated Hospital, Sun Yat-Sen University

    Guangzhou, Guangdong, 510000

  • Sir Run Run Shaw Hospital, Zhejiang University

    Hangzhou, Zhejiang, 310000

  • The First Affiliated Hospital, Zhejiang University

    Hangzhou, Zhejiang, 310000

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310000

  • The First Affiliated Hospital, Jilin University

    Jilin City, Jilin, 132000

  • The First Affiliated Hospital, Ningbo University

    Ningbo, Zhejiang, 315000

  • The Affiliated Hospital, Qingdao University

    Qingdao, Shandong, 266000

  • Cancer Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200000

  • ChangHai Hospital, The Second Military Medical University

    Shanghai, Shanghai Municipality, 200000

  • Shengjing Hospital, China Medical University

    Shenyang, Liaoning, 110000

  • The Second Affiliated Hospital, Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

  • Union Hospital, Huazhong University of Science and Technology

    Wuhan, Hubei, 430000

Other trials in China

About this study

Official title: The Safety and Efficiency of Stent-based Diverting Technique Versus Ileostomy in Rectal Cancer Patients: A Prospective, Multicenter, Open-label, Non-inferiority, Randomized Controlled Study

The goal of this clinical trial is to evaluate the safety and efficiency of stent-based tiverting technique (SDT) versus ileostomy in rectal cancer patients. After the removal of the rectal tumor, participants who are at high risk for anastomotic leakage will either undergo SDT or ileostomies. Researchers will compare SDT to see if SDT could help patients save hospital stays, lower medical costs, and enhance their quality of life, and not alternatively avoid defunction stoma.

Read the detailed description

In patients with rectal cancer who have a high risk of anastomotic leakage, we aim to compare the safety and effectiveness of SDT versus ileostomy in this study. The primary endpoint of the study was severe complications that occurred within 90 days of the surgery. The secondary endpoints included total complications, the incidence of coloanal anastomotic leakage (Grade B/C), postoperative hospital stay and cost, and postoperative quality of life evaluation.

Being tested
Stent-based Diverting Technique
Keywords
Stent-based diverting technique, Ileostomy, Complication, Anastomotic leakage
Medical subject headings
Rectal Neoplasms, Anastomotic Leak

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stent-based Diverting TechniqueProcedure or surgery

    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.

Study groups in NCT06204497
Study groupRoleWhat they receive
Stent-based Diverting TechniqueExperimentalFor 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.
Receives: Procedure: Stent-based Diverting Technique
IleostomyActive comparatorThere 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.
Receives: Procedure: Stent-based Diverting Technique

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of severe complications within 90-day

    Clavein-Dindo≥III

    Measured: Study group, from SDT to postoperative 90 days, Control group, from ileostomy to postoperative 90 days of reversal of stoma.

Secondary outcomes (5)

  1. Total complications

    Clavein-Dindo I to V

    Measured: Study group, from SDT to postoperative 90 days; Control group, from ileostomy, plus interval time before stoma reversal, to postoperative 90 days of reversal of stoma

  2. Clinical anastomotic leakage

    Grade B or Grade C

    Measured: Study group, from SDT to postoperative 90 days; Control group, from ileostomy, plus interval time before stoma reversal, to postoperative 90 days of reversal of stoma

  3. Postoperative hospital stay

    Postoperative hospital stay after SDT or ileostomy or reversal of stoma

    Measured: Study group, from SDT to discharge, and adding second postoperative hospital stay if the patient received the ileostomy. Control group, from ileostomy to discharge and from stoma reversal to discharge，up to six months for both group

  4. Total medical Costs

    Including medical costs, surgery costs and other costs

    Measured: From first admission to end of follow-up or date of death from any cause, whichever came first, assessed up to six months for both group

  5. Quality of life evaluation

    SF-8 scale

    Measured: Study group, 90 days after SDT; Control group, 90 days after ileostomy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2024
  2. Study start31 Jan 2024
  3. Primary completion28 Sep 2025
  4. Study completion28 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The patients who were enrolled will either undergo ileostomy or SDT after the removal of the rectal tumor, which will be decided by chance.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
570 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06204497
Sponsor's protocol ID
SRRSH.SDT
Status last verified
May 2026
First submitted
12 Dec 2023
Last updated
8 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data are available from the Principal Investigator upon reasonable request.

Publications

  • 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.

    PubMed 25830422

  • 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.

    PubMed 30239395

  • 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.

    PubMed 28746154

  • 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.

    PubMed 31255181

  • 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.

    PubMed 30704229

  • 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.

    PubMed 30217286

  • 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.

    PubMed 26706610

  • Rao S, Guren MG, Khan K, Brown G, Renehan AG, Steigen SE, Deutsch E, Martinelli E, Arnold D; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. 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.

    PubMed 34175386

  • 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.

    PubMed 20004450

  • 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.

    PubMed 15273542

  • Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

    PubMed 1593914

Questions about this trial

What is this clinical trial studying?

A study testing Stent-based Diverting Technique in people with Rectal Neoplasms, run by Sir Run Run Shaw Hospital at 20 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of severe complications within 90-day (time frame: Study group, from SDT to postoperative 90 days, Control group, from ileostomy to postoperative 90 days of reversal of stoma.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06204497, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.

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