Colonoscopic Sucralfate Spray in Prevention of Delayed Polypectomy Bleeding

Bleeding Clinical Trial

Official title:

Precise Administration of Sucralfate Powder in Prevention of Delayed Polypectomy Bleeding: a Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05817656
• Other study ID #: A-BR-111-085
• Status: Recruiting
• Phase: Phase 1
• Start date: May 15, 2023
• Est. completion date: April 14, 2024

Study information

• Verified date: April 2023
• Source: National Cheng-Kung University Hospital
• Contact: Hsueh-Chien Chiang, M.D.
• Phone: +886 2353535
• Email: scion456scion[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background： Colonoscopy can detect colon polyps and perform excision to the polyps to prevent colon cancer. However, polypectomy bleeding is one of the complications to be noticed, which has an occurrence rate of about 0.4%. Polypectomy bleeding is divided into two types, immediate and delayed bleeding. While immediate polypectomy bleeding can be treated with endoscopic hemostasis during the exam session, delayed polypectomy bleeding occurs a few hours or days after the colonoscopy exam. Patients who encountered delayed polypectomy bleeding usually presented to the hospital for hematochezia, symptoms of anemia, and even hemodynamic instability and end-organ damage. Cold snare polypectomy and prophylactic clipping can reduce the bleeding risk. However, delayed polypectomy bleeding still occurs in high-risk patients, e.g., larger polyps ≥ 1cm. Sucralfate is used for peptic ulcer treatment. It can become a protective layer on the wound to prevent environmental injury. Sucralfate can be used to treat colon ulcers, colitis, and radiation colitis. Whether sucralfate can prevent polypectomy wounds from delayed bleeding is unknown.

Aim： This study aimed to investigate whether precise sucralfate administration on polypectomy wounds can prevent the wound from delayed bleeding.

Method： This is a randomized clinical trial. The study will recruit 160 patients. After randomization, 80 patients will be classified into the intervention group and 80 into the control group. The participants will receive an endoscopic survey as routine, and we will enroll all patients with polyp size ≥ 0.5 cm after polyp excision. Exclusion criteria include patients with an allergy to sucralfate. If immediate polypectomy bleeding occurs, we will apply standard endoscopic therapy by either local injection of diluted epinephrine, heater probe coagulation, and/or hemoclipping. If there is no immediate bleeding, we will apply prophylactic clipping in high-risk patients with polyp size ≥ 1cm. After then, we will spray 3g of sucralfate powder through colonoscopy precisely on the polypectomy wound in the intervention group. All enrolled patients will be monitored for delayed bleeding for 28 days after the colonoscopy.

Description:

Colonoscopy is the gold standard for the detection of colon polyps for cancer prevention. Colonoscopic polypectomy with the snare is an effective and safe procedure. However, polypectomy bleeding has about a 0.4 % event rate. Polypectomy bleeding can be divided into two types- immediate or delayed polypectomy bleeding. Immediate polypectomy bleeding occurs right after the polyp excision, which can be detected right away with endoscopic hemostasis treatment. Old age ≥ 65 years, comorbid cardiovascular or chronic kidney disease, antiplatelet or anticoagulant agents use, polyp size > 1 cm, laterally spreading polyp, and thick polyp stalk was related to an increased risk of immediate polypectomy bleeding. In contrast, delayed polypectomy bleeding occurs hours or days after the polypectomy. Polyp size > 1 cm, antiplatelet or anticoagulant agents use, the occurrence of immediate polypectomy bleeding, and polyps at the right colon are known risk factors for delayed polypectomy bleeding. An increased size of polyp for every 1 mm significantly increased bleeding by 13%5. Patients who encountered delayed polypectomy bleeding usually presented to the hospital for hematochezia, symptoms of anemia, and even hemodynamic instability and end-organ damage. A polypectomy bleeding-related mortality related was reported at about 0.08%.

At National Cheng Kung University Hospital, we analyzed about 20000 patients underwent colon polypectomy from 2010/01/01 to 2022/07/31. A total of 71 patients encountered delayed polypectomy bleeding, and 29 patients (41%) were with colon polyp size between 0.5 - 1 cm. Polyps with size ≥ 0.5 cm were all at risk of delayed polypectomy bleeding. How to prevent delayed polypectomy bleeding is an important issue for both endoscopists and patients.

Regarding the method of polypectomy, a systemic review and meta-analysis pointed out that cold snare polypectomy was with a lower delayed bleeding risk than hot snare polypectomy. However, only colon polyps ≤ 1 cm were preferred candidates for cold snare polypectomy. Wound closure with clipping after polypectomy is another method to reduce the risk of delayed polypectomy bleeding. For colon polyps > 2 cm in diameter, prophylactic clipping after polypectomy reduces the incidence rate of delayed bleeding. For colon polyps < 2 cm in diameter, prophylactic clipping was not associated with delayed bleeding occurrence. However, delayed polypectomy bleeding still occurs after clipping.

Sucralfate is a complex of aluminum hydroxide and sucrose octasulfate. Sucralfate dissociates in the acid environment to an anionic form, which can bind to the wound base subsequently. This protective barrier can prevent the wound from further environmental injury. Sucralfate has been widely used for wounds and ulcer treatment, e.g., skin wounds, oral ulcers, peptic ulcers, and colon ulcers. Sucralfate can also improve the clinical response to radiation colitis. With the protective effect of the colon mucosa, sucralfate can cover the polypectomy wound and has the potential to avoid further environmental damage from the colon. However, the effect of sucralfate on the prevention of polypectomy bleeding has not been evaluated. This study aimed to investigate whether the precise sucralfate administration on polypectomy wounds can prevent the wound from delayed bleeding.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: April 14, 2024
• Est. primary completion date: April 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• who accept colonoscopy examinations with polyp size = 0.5 cm for polyp excision

Exclusion Criteria:

• patients with an allergy to sucralfate

• patients rejection

Related Conditions & MeSH terms

• Bleeding
• Hemorrhage

Intervention

Drug:
• Sucralfate
3g of sucralfate powder through colonoscopy will be sprayed precisely on the polypectomy wound in the intervention group

Locations

Country	Name	City	State
Taiwan	Hsueh-Chien Chiang	Tainan	Other (Non U.s.)

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (20)

Ala S, Saeedi M, Janbabai G, Ganji R, Azhdari E, Shiva A. Efficacy of Sucralfate Mouth Wash in Prevention of 5-fluorouracil Induced Oral Mucositis: A Prospective, Randomized, Double-Blind, Controlled Trial. Nutr Cancer. 2016;68(3):456-63. doi: 10.1080/016 — View Citation

Boumitri C, Mir FA, Ashraf I, Matteson-Kome ML, Nguyen DL, Puli SR, Bechtold ML. Prophylactic clipping and post-polypectomy bleeding: a meta-analysis and systematic review. Ann Gastroenterol. 2016 Oct-Dec;29(4):502-508. doi: 10.20524/aog.2016.0075. Epub 2 — View Citation

Buddingh KT, Herngreen T, Haringsma J, van der Zwet WC, Vleggaar FP, Breumelhof R, Ter Borg F. Location in the right hemi-colon is an independent risk factor for delayed post-polypectomy hemorrhage: a multi-center case-control study. Am J Gastroenterol. 2 — View Citation

Derbyshire E, Hungin P, Nickerson C, Rutter MD. Post-polypectomy bleeding in the English National Health Service Bowel Cancer Screening Programme. Endoscopy. 2017 Sep;49(9):899-908. doi: 10.1055/s-0043-113442. Epub 2017 Jul 28. — View Citation

Ferlitsch M, Moss A, Hassan C, Bhandari P, Dumonceau JM, Paspatis G, Jover R, Langner C, Bronzwaer M, Nalankilli K, Fockens P, Hazzan R, Gralnek IM, Gschwantler M, Waldmann E, Jeschek P, Penz D, Heresbach D, Moons L, Lemmers A, Paraskeva K, Pohl J, Poncho — View Citation

Fernandez OOA, Pereira JA, Campos FG, Araya CM, Marinho GE, Novo RS, Oliveira TS, Franceschi YT, Martinez CAR. EVALUATION OF ENEMAS CONTAINING SUCRALFATE IN TISSUE CONTENT OF MUC-2 PROTEIN IN EXPERIMENTAL MODEL OF DIVERSION COLITIS. Arq Bras Cir Dig. 2017 — View Citation

Hassan C, Repici A, Sharma P, Correale L, Zullo A, Bretthauer M, Senore C, Spada C, Bellisario C, Bhandari P, Rex DK. Efficacy and safety of endoscopic resection of large colorectal polyps: a systematic review and meta-analysis. Gut. 2016 May;65(5):806-20 — View Citation

Hunt RH. Treatment of peptic ulcer disease with sucralfate: a review. Am J Med. 1991 Aug 8;91(2A):102S-106S. doi: 10.1016/0002-9343(91)90459-b. — View Citation

Kim HS, Kim TI, Kim WH, Kim YH, Kim HJ, Yang SK, Myung SJ, Byeon JS, Lee MS, Chung IK, Jung SA, Jeen YT, Choi JH, Choi KY, Choi H, Han DS, Song JS. Risk factors for immediate postpolypectomy bleeding of the colon: a multicenter study. Am J Gastroenterol. — View Citation

Kochhar R, Sriram PV, Sharma SC, Goel RC, Patel F. Natural history of late radiation proctosigmoiditis treated with topical sucralfate suspension. Dig Dis Sci. 1999 May;44(5):973-8. doi: 10.1023/a:1026612731210. — View Citation

Masuelli L, Tumino G, Turriziani M, Modesti A, Bei R. Topical use of sucralfate in epithelial wound healing: clinical evidences and molecular mechanisms of action. Recent Pat Inflamm Allergy Drug Discov. 2010 Jan;4(1):25-36. doi: 10.2174/18722131078989564 — View Citation

Matsumoto M, Kato M, Oba K, Abiko S, Tsuda M, Miyamoto S, Mizushima T, Ono M, Omori S, Takahashi M, Ono S, Mabe K, Nakagawa M, Nakagawa S, Kudo T, Shimizu Y, Sakamoto N. Multicenter randomized controlled study to assess the effect of prophylactic clipping — View Citation

McElvanna K, Wilson A, Irwin T. Sucralfate paste enema: a new method of topical treatment for haemorrhagic radiation proctitis. Colorectal Dis. 2014 Apr;16(4):281-4. doi: 10.1111/codi.12507. — View Citation

Nagashima R. Mechanisms of action of sucralfate. J Clin Gastroenterol. 1981;3(Suppl 2):117-27. — View Citation

Park SK, Seo JY, Lee MG, Yang HJ, Jung YS, Choi KY, Kim H, Kim HO, Jung KU, Chun HK, Park DI. Prospective analysis of delayed colorectal post-polypectomy bleeding. Surg Endosc. 2018 Jul;32(7):3282-3289. doi: 10.1007/s00464-018-6048-9. Epub 2018 Jan 17. — View Citation

Qu J, Jian H, Li L, Zhang Y, Feng B, Li Z, Zuo X. Effectiveness and safety of cold versus hot snare polypectomy: A meta-analysis. J Gastroenterol Hepatol. 2019 Jan;34(1):49-58. doi: 10.1111/jgh.14464. Epub 2018 Sep 26. — View Citation

Shinozaki S, Kobayashi Y, Hayashi Y, Sakamoto H, Lefor AK, Yamamoto H. Efficacy and safety of cold versus hot snare polypectomy for resecting small colorectal polyps: Systematic review and meta-analysis. Dig Endosc. 2018 Sep;30(5):592-599. doi: 10.1111/de — View Citation

Turan AS, Pohl H, Matsumoto M, Lee BS, Aizawa M, Desideri F, Albeniz E, Raju GS, Luba D, Barret M, Gurudu SR, Ramirez FC, Lin WR, Atsma F, Siersema PD, van Geenen EJM; Prophylactic Clipping Collaborative Group. The Role of Clips in Preventing Delayed Blee — View Citation

Wang YW, Chen HH, Wu MS, Chiu HM; Taiwanese Nationwide Colorectal Cancer Screening Program. Current status and future challenge of population-based organized colorectal cancer screening: Lesson from the first decade of Taiwanese program. J Formos Med Asso — View Citation

Zhang Q, An Sl, Chen Zy, Fu FH, Jiang B, Zhi Fc, Bai Y, Gong W. Assessment of risk factors for delayed colonic post-polypectomy hemorrhage: a study of 15553 polypectomies from 2005 to 2013. PLoS One. 2014 Oct 1;9(10):e108290. doi: 10.1371/journal.pone.010 — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of delayed polypectomy bleeding	The occurrence of delayed polypectomy bleeding. Delayed polypectomy was classified into standard criteria and extended criteria. Standard criteria of delayed postpolypectomy bleeding was defined as emergency attendance, hospitalisation, or need for re-intervention. Extended criteria was defined as blood in stool two days after procedure with or without spontaneous remission.	28 days
Secondary	Incidence rate of need of TAE or surgery	polypectomy wound bleeding requiring transarterial embolization or emergency surgery	28 days
Secondary	length of hospitalization	length of hospitalization due to polyepctomy bleeding	28 days
Secondary	all-cause mortality	all-cause mortality	28 days