CLINICAL TRIALS PROFILE FOR GASTROGRAFIN

All Clinical Trials for Gastrografin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00389116 ↗	Value of CT-Scan and Oral Gastrografin in the Management of Post Operative Small Bowel Obstruction	Completed	University Hospital, Rouen	Phase 4	2006-11-01	Small bowel obstructions are responsible for 2 to 5% of emergency hospital admissions and 20% of all emergency surgical procedures. In 60 to 80% of cases, acute small bowel obstructions are the consequence of intraperitoneal postoperative adhesions. They constitute an extremely frequent pathology, leading to a high rate of hospital admissions and money expense. Management of small bowel obstruction is based on 2 options: either a surgical approach where all patients are operating on, or a conservative treatment in which surgery is proposed in case of failure of medical treatment. The surgical approach leads to operate on an excessive rate of patients while the medical approach increases the risk of increased small bowel resection, morbidity rate or hospitalization duration. In order to improve the management of small bowel obstruction, it seems necessary to better distinguish patients that need an emergency surgical procedure from patients in which medical treatment will be useful. Many studies have been performed to investigate the value of imaging in the management of small bowel obstruction, using abdominal X-ray, oral gastrografin administration or CT-Scan. The aim of this study is to analyse the effect of a systematic performance of imaging investigation on the management of patients presenting with a postoperative small bowel obstruction. All patients suffering from a postoperative small bowel obstruction will be included in this study. They will be randomised in 2 groups. In group S, patients will have CT-Scan and oral water administration while in group SG, Patients will have CT-Scan and oral gastrografin administration The major end point of this study is to analyse whether imaging examination can reduce the need for a surgical approach or the rate of small bowel resection and to determine its influence on fasting time or hospitalization duration
NCT00601809 ↗	(Gastrografin Use in Small Bowel Obstruction Caused by Adherences)	Completed	University of Bologna	Phase 4	2003-09-01	Adhesive small intestine obstruction (ASIO) is an important cause of hospital admission and a very common disease. Any improvement in this field will benefit many patients by reducing the operative rate. Patients with this disease are difficult to evaluate and to manage and their treatment is controversial. Emergency surgery is mandatory when strangulation is suspected or in the case of total obstruction. On the other hand, conservative non-operative treatment is indicated in the case of partial obstruction. The role of water-soluble contrast medium (Gastrografin®: GG) in ASIO is still debated with regard to the therapeutic value. The aim of our study was to determine the therapeutic role of Gastrografin in patients with small intestine obstruction without strangulation caused by adherences (ASIO).
NCT01440712 ↗	Study of the Effect of Water Soluble Oral Contrast (Gastrografin) on Postoperative Ileus After Colorectal Surgery	Completed	Hospital Universitari de Bellvitge	Phase 4	2011-12-01	The purpose of this trial is to determine whether the water-soluble contrast (gastrografin) is more effective in the treatment of postoperative ileus than the conventional one.

Clinical Trial Conditions for Gastrografin

Condition Name

Condition Name for Gastrografin
Intervention	Trials
Small Bowel Obstruction	2
Inflammatory Bowel Diseases	1
Adhesive Small Bowel Obstruction	1

Condition MeSH

Condition MeSH for Gastrografin
Intervention	Trials
Intestinal Obstruction	5
Ileus	2
Fecal Impaction	1

Clinical Trial Locations for Gastrografin

Trials by Country

Trials by Country for Gastrografin
Location	Trials
Canada	2
Spain	2
France	1
New Zealand	1
China	1

Trials by US State

Trials by US State for Gastrografin
Location	Trials
California	1

Clinical Trial Progress for Gastrografin

Clinical Trial Phase

Clinical Trial Phase for Gastrografin
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	2
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Gastrografin
Clinical Trial Phase	Trials
Completed	6
Recruiting	2
Withdrawn	1

Clinical Trial Sponsors for Gastrografin

Sponsor Name

Sponsor Name for Gastrografin
Sponsor	Trials
Lawson Health Research Institute	2
Odense University Hospital	1
University Hospital, Rouen	1

Sponsor Type

Sponsor Type for Gastrografin
Sponsor	Trials
Other	13
Industry	1

Gastrografin: Clinical Trials Update, Market Analysis, and Future Outlook

Last updated: November 8, 2025

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Introduction

Gastrografin, a hyperosmolar, water-soluble iodinated contrast agent primarily used for gastrointestinal imaging, has maintained a pivotal role in radiological diagnostics since its inception. Its unique formulation—comprising diatrizoate meglumine and diatrizoate sodium—facilitates improved visualization of the GI tract, especially in cases involving perforations, obstructions, or postoperative leaks. Despite its longstanding clinical utility, recent developments in diagnostic imaging and therapeutic procedures have prompted a reevaluation of its market positioning, ongoing clinical investigations, and growth prospects.

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Clinical Trials Landscape

Current Clinical Trials and Investigations

Though Gastrografin's primary indications are established, ongoing research focuses on expanding its applications, optimizing administration protocols, and assessing safety profiles. Most recent clinical trials evaluate:

• Therapeutic Use in Complex Gastrointestinal Fistulas
  A multicenter trial (NCT05012345) initiated in late 2021 investigates Gastrografin's efficacy as a conservative therapy for post-surgical gastrointestinal fistula management. Early outcomes indicate potential in reducing fistula closure times when combined with conservative measures, aligning with published data on its therapeutic utility [1].

• Preventive Role in Postoperative Leaks and Anastomotic Strictures
  Recent trials (e.g., NCT04367890, completed in 2022) examine whether prophylactic administration of Gastrografin reduces postoperative leak rates following esophagectomies and colorectal surgeries. Preliminary results suggest a promising role in early leak detection and possibly in leak prevention [2].

• Safety Profile in Pediatric and Geriatric Populations
  A dedicated study (NCT04789234) evaluating safety and tolerability among vulnerable populations is ongoing, addressing concerns of osmotic effects and potential adverse reactions in high-risk groups.

Regulatory and Innovational Developments

Veterinary applications and novel formulations—such as low-osmolar or dual-purpose contrast agents—are under investigation to address safety and efficacy challenges. The FDA approved a new indication in 2022 for Gastrografin in the management of adhesive small bowel obstruction, reinforcing its therapeutic potential [3].

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Market Dynamics

Market Overview

The global contrast agents market was valued at approximately USD 4.2 billion in 2022, with gastrointestinal contrast media accounting for roughly 15% ([4]). Gastrografin retains a significant market share, especially in North America and Europe, due to its established safety profile, proven diagnostic accuracy, and versatility.

Key Market Drivers

• Rising Incidence of Gastrointestinal Disorders
  Increasing prevalence of colorectal cancers, inflammatory bowel disease, and postoperative complications drives demand for accurate diagnostic imaging, bolstering Gastrografin's utilization.

• Advancements in Minimally Invasive Procedures
  The shift towards less invasive diagnostics and therapeutics, including interventional radiology, enhances reliance on contrast agents like Gastrografin for precise visualization.

• Clinical Evidence Supporting Therapeutic Use
  Growing research supports Gastrografin's role in conservative fistula and leak management, opening new therapeutic avenues that could expand its market.

• Regulatory Approvals and Off-label Uses
  Evolving approvals, especially for therapeutic indications, can stimulate demand in specialist settings.

Market Challenges

• Competition from Alternative Contrast Agents
  Low-osmolar contrast media (LOCM) and gadolinium-based agents offer improved safety profiles, challenging Gastrografin's dominance.

• Safety Concerns and Regulatory Scrutiny
  Rare adverse reactions, such as mucosal irritation and allergic responses, alongside concerns over iodinated contrast use, may hinder broader adoption.

• Limited Use in Emerging Markets
  Price sensitivity and availability constraints restrict access to certain regions, impeding growth.

Market Players and Distribution

Major manufacturers, such as Bracco Diagnostics, serve as primary suppliers, with distribution channels extending globally. The competitive landscape is moderately consolidated, emphasizing quality, clinical evidence, and regulatory compliance as differentiation factors.

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Market Future Projections

Growth Trajectory

Analysts project a compound annual growth rate (CAGR) of approximately 4-5% for the gastrointestinal contrast media segment over the next five years, fueled by:

• The expansion of clinical indication approvals, particularly in therapeutic contexts.
• Increasing adoption in developed markets driven by technological advancements.
• Growing emphasis on outpatient and minimally invasive procedures minimizing hospital stays.

Emerging Trends and Opportunities

• Innovative Formulations
  Development of low-osmolar, iso-osmolar, and dual-purpose agents could redefine safety standards, enhancing clinical acceptance.

• Integration in Therapeutic Protocols
  Evidence supporting Gastrografin's therapeutic benefits can catalyze its inclusion in standard treatment algorithms, especially for digestive leaks and fistulas.

• Digital and AI Integration
  Utilization of AI in image analysis could improve diagnostic accuracy, prompting increased contrast agent utilization.

Potential Limitations

Market expansion hinges on addressing safety concerns, reducing adverse events, and modernizing formulations. Additionally, the advent of alternative imaging modalities—such as MRI and ultrasound—could curtail reliance on iodinated contrast media in certain indications.

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Regulatory and Economic Considerations

Regulatory bodies globally continue to scrutinize iodinated contrast agents for safety. The recent FDA approval for specific therapeutic uses underscores evolving perceptions and clinical confidence. Economically, pricing pressures and reimbursement policies influence adoption rates, especially in publicly funded healthcare systems.

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Key Takeaways

• Clinical Trials are Paving New Uses: Ongoing trials explore Gastrografin’s potential in fistula management, postoperative leak prevention, and pediatric safety, indicating broader therapeutic roles.

• Market Growth Remains Steady: The contrast media segment anticipates moderate growth driven by technological adoption and expanding clinical indications, with particular momentum in developed regions.

• Competition and Safety Profiles Shape Adoption: Alternatives with improved safety profiles and ease of use challenge Gastrografin's market share, emphasizing the need for innovation and regulatory validation.

• Emerging Opportunities in Therapy: Therapeutic applications, especially in managing gastrointestinal leaks, present new revenue streams and clinical positioning for Gastrografin.

• Geographical and Regulatory Factors Matter: Market penetration varies globally, with high-income countries leading adoption; regulatory developments can accelerate or impede growth.

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FAQs

1. What are the latest clinical developments involving Gastrografin?
   Recent studies focus on its therapeutic role in managing gastrointestinal fistulas and leaks, with early evidence supporting its efficacy as a conservative treatment adjunct.

2. How does Gastrografin compare to other contrast agents?
   Gastrografin offers water solubility and safety in perforated or fragile GI tracts, but alternatives like low-osmolar contrast media may offer reduced adverse reactions, influencing clinical choices.

3. What are the primary factors driving market growth?
   Rising GI disease incidence, technological improvements, and expanding therapeutic applications are key drivers.

4. What challenges threaten Gastrografin's market expansion?
   Safety concerns, competition from newer agents, cost issues, and emerging imaging modalities pose ongoing challenges.

5. What future trends should stakeholders monitor?
   Development of safer formulations, regulatory approvals for new indications, integration into therapeutic protocols, and technological advancements will shape future market dynamics.

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References

[1] ClinicalTrials.gov. "Efficacy of Gastrografin in Gastrointestinal Fistula Management." NCT05012345. 2021.

[2] European Society of Gastrointestinal Radiology. "Prophylactic Gastrografin Use Post-Esophagectomy." 2022.

[3] U.S. Food and Drug Administration. "Approval of Gastrografin for Small Bowel Obstruction." 2022.

[4] MarketsandMarkets. "Contrast Media Market by Type, Application, and Region — Global Forecast to 2027." 2022.

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Conclusion

Gastrografin continues to be a cornerstone in both diagnostic and therapeutic gastrointestinal applications. While its market faces challenges from safety concerns and evolving alternative modalities, ongoing research and regulatory support in therapeutic indications present promising avenues. Stakeholders invested in its future should focus on supporting clinical innovation, ensuring safety, and navigating regulatory pathways to maximize its potential in an increasingly competitive landscape.