bêta
IA Trial Radar
L'essai clinique NCT06204497 pour Néoplasmes Rectaux est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
Un essai clinique correspond aux filtres sélectionnés
Vue en carte
Retour à la recherche

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

En recrutement
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'essai' pour voir et discuter des informations sur l'essai dans la langue sélectionnée.
L'étude clinique NCT06204497 est un essai interventionnel pour Néoplasmes Rectaux. Son statut actuel est : en recrutement. L'étude a débuté le 31 janvier 2024 et vise à recruter 570 participants. Dirigé par Sir Run Run Shaw Hospital, l'essai devrait être terminé d'ici le 1 juin 2025. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 12 janvier 2024.
Résumé succinct
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.
Description détaillée
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.
Titre officiel

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

Conditions
Néoplasmes Rectaux
Publications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:
Autres identifiants de l'essai
  • SRRSH.SDT
Numéro NCT
NCT06204497
Date de début (réel)
2024-01-31
Dernière mise à jour publiée
2024-01-12
Date de fin (estimée)
2025-06
Inscription (estimée)
570
Type d'essai
Interventionnel
PHASE
N/A
Statut
En recrutement
Mots clés
Stent-based diverting technique
Ileostomy
Complication
Anastomotic leakage
Objectif principal
Traitement
Plan d'attribution
Randomisé
Modèle d'intervention
Parallèle
Masquage
Simple aveugle
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalStent-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.
Comparateur actifIleostomy
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.
Critère principal d'évaluation
Critères d'évaluationDescription de critèresPériode
Incidence of severe complications within 90-day
Clavein-Dindo≥III
Study group, from SDT to postoperative 90 days, Control group, from ileostomy to postoperative 90 days of reversal of stoma.
Critère secondaire d'évaluation
Critères d'évaluationDescription de critèresPériode
Total complications
Clavein-Dindo I to V
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
Clinical anastomotic leakage
Grade B or Grade C
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
Postoperative hospital stay
Postoperative hospital stay after SDT or ileostomy or reversal of stoma
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
Total medical Costs
Including medical costs, surgery costs and other costs
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
Quality of life evaluation
SF-8 scale
Study group, 90 days after SDT; Control group, 90 days after ileostomy
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
  1. Rectal adenocarcinoma confirmed pathologically.
  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.

  1. History of previous rectectomy, except endoscopic mucosal resection or endoscopic submucosal dissection.
  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).
Sir Run Run Shaw Hospital logoSir Run Run Shaw Hospital
Partie responsable de l'essai
Xiujun Cai, Investigateur principal, Director, Head of General Surgery, Principal Investigator, Clinical Professor, Sir Run Run Shaw Hospital
Contact central de l'essai
Contact: Yifan Tong, PhD, +86-571-13732207321, [email protected]
Contact: Lingfei Li, bachelor, +86-571-13588708122, [email protected]
20 Centres de l'essai dans 1 pays

Beijing Municipality

Beijing Friendship Hospital, Beijing, Beijing Municipality, 100000, China
Zhongtao Zhang, MD, Contact, +86-571-13801060364, [email protected]
Hongwei Yao, MD, Contact, +86-571-13611015609
Zhongtao Zhang, MD, Investigateur principal
Hongwei Yao, MD, Investigateur associé
Pas encore en recrutement
Cancer Hospital, Peking University, Beijing, Beijing Municipality, 100000, China
Aiwen Wu, MD, Contact, +86-571-13911577190, [email protected]
Aiwen Wu, MD, Investigateur principal
Pas encore en recrutement
Peking Union Hospital, Beijing, Beijing Municipality, 100000, China
Yi Xiao, MD, Contact, +86-571-13366036387, [email protected]
Yi Xiao, MD, Investigateur principal
Pas encore en recrutement
Chinese PLA General Hospita, Beijing, Beijing Municipality, 310000, China
Xiaohui, MD, Contact, +86-571-13801300826, [email protected]
Xiaohui Xiaohui, MD, Investigateur principal
Pas encore en recrutement

Fujian

Fujian Union Hospital, Fujian Medical University, Fuzhou, Fujian, 350000, China
Pan Chi, MD, Contact, +86-571-13675089677, [email protected]
Pan Chi, MD, Investigateur principal
Pas encore en recrutement

Guangdong

The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, 510000, China
Wu Song, MD, Contact, +86-571-13824444536, [email protected]
Wu Song, MD, Investigateur principal
Pas encore en recrutement

Hubei

Union Hospital, Huazhong University of Science and Technology, Wuhan, Hubei, 430000, China
Kaixiong Tao, MD, Contact, +86-571-13507155452, [email protected]
Peng Zhang, MD, Contact, +86-571-18186100993
Kaixiong Tao, MD, Investigateur principal
Peng Zhang, MD, Investigateur associé
Pas encore en recrutement

Hunan

Xiangya Hospital, Central South Universit, Changsha, Hunan, 410000, China
Zhikang Chen, MD, Contact, +86-571-13973114538, [email protected]
Zhikang Chen, MD, Investigateur principal
Pas encore en recrutement

Jilin

The First Affiliated Hospital, Jilin University, Jilin, Jilin, 132000, China
Quan Wang, MD, Contact, +86-571-13944810508, [email protected]
Quan Wang, MD, Investigateur principal
Pas encore en recrutement

Liaoning

Shengjing Hospital, China Medical University, Shenyang, Liaoning, 110000, China
Dingsheng Liu, MD, Contact, +86-571-18940255438, [email protected]
Dingsheng Liu, MD, Investigateur principal
Pas encore en recrutement

Shandong

The Affiliated Hospital, Qingdao University, Qingdao, Shandong, 266000, China
Yun Lu, MD, Contact, +86-571-18661802231, [email protected]
Yun Lu, MD, Investigateur principal
Pas encore en recrutement

Shanghai Municipality

Cancer Hospital, Fudan University, Shanghai, Shanghai Municipality, 200000, China
Xinxiang Li, MD, Contact, +86-571-13761291659, [email protected]
Xinxiang Li, MD, Investigateur principal
Pas encore en recrutement
ChangHai Hospital, The Second Military Medical University, Shanghai, Shanghai Municipality, 200000, China
Wei Zhang, MD, Contact, +86-571-13816321041, [email protected]
Wei Zhang, MD, Investigateur principal
Pas encore en recrutement

Sichuan

Sichuan Cancer Hospital, University of Electronic Science and Technology of China, Chengdu, Sichuan, 610000, China
Hai Hu, MD, Contact, +86-571-13540662185, [email protected]
Hai Hu, MD, Investigateur principal
Pas encore en recrutement
Sichuan Provincial People's Hospital, Chengdu, Sichuan, 610000, China
Minghui Pang, MD, Contact, +86-571-18981838525, [email protected]
Minghui Pang, MD, Investigateur principal
Pas encore en recrutement

Zhejiang

Sir Run Run Shaw Hospital, Zhejiang University, Hangzhou, Zhejiang, 310000, China
Zhangfa Song, MD, Contact, +86-571-13867421652, [email protected]
Xiujun Cai, MD, Investigateur principal
Zhangfa Song, MD, Investigateur associé
En recrutement
The First Affiliated Hospital, Zhejiang University, Hangzhou, Zhejiang, 310000, China
Wenbin Chen, MD, Contact, +86-571-13396553806, [email protected]
Wenbin Chen, MD, Investigateur principal
Pas encore en recrutement
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, 310000, China
Weiping Chen, MD, Contact, +86-571-13505714856, [email protected]
Weiping Chen, MD, Investigateur principal
Pas encore en recrutement
The First Affiliated Hospital, Ningbo University, Ningbo, Zhejiang, 315000, China
Zhilong Yan, MD, Contact, +86-571-18868754958, [email protected]
Zhilong Yan, MD, Investigateur principal
Pas encore en recrutement
The Second Affiliated Hospital, Wenzhou Medical University, Wenzhou, Zhejiang, 325000, China
Yaojun Yu, MD, Contact, +86-571-13868849180, [email protected]
Yaojun Yu, MD, Investigateur principal
Pas encore en recrutement