Second-look Endoscopy in High Risk Patients After Endoscopic Hemostasis to Their Bleeding Peptic Ulcers Improves Their Outcomes

NCT02352155 | Terminated DMC

• 1 other identifier: SLOGD
• Study Type: interventional
• Target: 157
• Locations: 2 countries
• Sites: 2

Brief Summary

Bleeding peptic ulcer is a common medical emergency. Endoscopic treatment stops bleeding in those actively bleeding from their peptic ulcers, reduces further bleeding, transfusion, surgery and deaths. After initial endoscopic control of bleeding, approximately 10% of them will develop recurrent bleeding. Mortality rate in this group of patients is at least 4 fold higher. In the few who need surgery, mortality approaches 30%. Prevention of further bleeding is therefore a major treatment objective. Currently the investigators use a high dose infusion of proton pump inhibitor (PPI) for 72 hours to render gastric pH neutral. In a previous randomized trial, the investigators showed that the rate of bleeding in 30 days was around 7% with such an approach. In a small subgroup of high risk patients defined by presentation with shock and ulcers \> 2 cm in size, 1 in 6 would re-bleed. An alternate strategy is to select those at especially high risk of further bleeding and repeat endoscopic treatment the next morning. The investigators have shown that persistence of major bleeding stigmata, i.e. a visible vessel, during a second endoscopy predicts further bleeding. It is therefore logical that by repeating endoscopic treatment the next morning, the investigators can prevent further bleeding and possibly surgery and deaths. The current study proposes to develop a score to identify those at risk of further bleeding after endoscopy. The investigators used a historical cohort with carefully collected clinical data to derive a risk score. In this derivation phase of 939 patients, the investigators have developed a 9 point risk score which consists of the following parameters (Age\>60, Male sex, ulcer\>2cm, posterior bulbar in location, spurting or Forrest Ia bleeding and admission hemoglobin of \< 8 g/dl). Using AUROC and Youden J statistics, a score of 5 or above has been shown to highly predictive of further bleeding. The score will then be validated in a prospective cohort of patients with bleeding peptic ulcers. In the final phase of this study, the investigators propose a randomized controlled trial to test the hypothesis that a second look endoscopy with treatment in selected high risk patients can further reduce bleeding and improve their outcomes. After endoscopic hemostasis to their bleeding peptic ulcers, patients are risk stratified based on the score. Those with a score of 5 or more are randomized to receive the standard treatment (a high dose PPI infusion) or a second look endoscopy with treatment in addition to PPI infusion. The primary outcome to the trial is further significant clinical bleeding.

Conditions

Ulcer Bleeding

Keywords

haemostasis

Outcome Measures

Primary Outcomes (1)

• clinical significant bleeding

  1\) fresh hematemesis or melena and 2) hypotensive with systolic blood pressure less than or equal to 90 mmHg and pulse rate of greater than or equal to 110 per minute and/ or a drop of haemoglobin of \>2g/dl in 24 hours and a hematocrit of 0.24. Further bleeding has to be documented by endoscopic findings or fresh blood in the stomach together with a bleeding or non-bleeding visible vessel.

  30 days

Secondary Outcomes (5)

• additional intervention for further bleeding

  30 days

• blood transfusion

  30 days

• hospitalisation,

  30 days

• treatment related complications

  30 days

• deaths from all causes

  30 days

Study Arms (2)

Second look endoscopy

ACTIVE COMPARATOR

Second look endoscopy in the following morning with re-treatment to the bleeding vessel using epinephrine injection or heater probe or hemoclips

Procedure: epinephrine injection or heater probe or hemoclips

observation only

PLACEBO COMPARATOR

NO second look endoscopy (Observation)

Other: Observation only

Interventions

epinephrine injection or heater probe or hemoclips PROCEDURE

Elective Second look endoscopy in the following morning with re-treatment to the bleeding vessel using epinephrine injection or heater probe or hemoclips

Second look endoscopy

Observation only OTHER

Observation for rebleeding, unscheduled endoscopy only when rebleeding criteria fulfilled

Also known as: Observation for rebleeding

observation only

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>=18
• Informed consent obtained
• Successful endoscopic hemostasis
• Risk Score \>= 5

You may not qualify if:

• Age \< 18
• Pregnancy
• Incomplete endoscopic haemostasis -

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (2)

Endoscopy Centre

Hong Kong, HONG KONG, China

Location

Chulalongkorn Memorial Hospital

Bangkok, Pathumwan, 10330, Thailand

Location

Related Publications (1)

• Pittayanon R, Suen BY, Kongtub N, Tse YK, Rerknimitr R, Lau JYW. Scheduled second look endoscopy after endoscopic hemostasis to patients with high risk bleeding peptic ulcers: a Randomized Controlled Trial. Surg Endosc. 2022 Sep;36(9):6497-6506. doi: 10.1007/s00464-021-09004-w. Epub 2022 Jan 12.

  PMID: 35020056 DERIVED

MeSH Terms

Interventions

Epinephrine; Observation

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Methods; Investigative Techniques

Study Officials

• James Y LAU, Prof

  CUHK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 15, 2014
• First Posted: February 2, 2015
• Study Start: February 4, 2015
• Primary Completion: April 2, 2020
• Study Completion: April 2, 2020
• Last Updated: July 15, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1); TH (1)