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Evaluation of Hydrocortisone, Octreotide, and Teres Ligament Patch Combination to Prevent Complications After Pancreatoduodenectomy in Patients with Pancreatic Head Cancer or IPMN

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study investigates a treatment approach for patients undergoing pancreatoduodenectomy (a surgical procedure that removes the head of the pancreas, part of the small intestine, gallbladder, and bile duct) for conditions such as pancreatic head carcinoma or intraductal papillary mucinous neoplasms (growths in the pancreatic ducts that can sometimes become cancerous). The research focuses on patients who have a small pancreatic duct (3mm or less in diameter), which increases the risk of complications after surgery.

The purpose of this study is to determine if a combined treatment called the HOP bundle can reduce major complications after pancreatoduodenectomy surgery. This bundle consists of three components: hydrocortisone (a steroid medication that reduces inflammation), octreotide (a medication that reduces pancreatic secretions), and a teres ligament patch (a piece of tissue used to reinforce the surgical connection).

Participants in the study will undergo pancreatoduodenectomy surgery and will be randomly assigned to either receive the HOP bundle treatment or standard care. The researchers will monitor patients for various complications that can occur after this type of surgery, including pancreatic fistula (leakage of pancreatic fluid), delayed gastric emptying (slow emptying of the stomach), post-pancreatectomy hemorrhage (bleeding after surgery), and other potential issues.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Surgery and Randomization

    You will undergo a pancreatoduodenectomy, which is a surgical procedure to remove part of the pancreas, usually for conditions such as pancreatic head carcinoma or abnormal growths in the pancreas.

    During the surgery, you will be randomly assigned to either receive the treatment bundle or standard care. You will not be able to choose which group you are placed in.

  2. Step 2

    Treatment Bundle (for patients in the treatment group)

    If you are assigned to the treatment group, you will receive a combination of treatments called the HOP bundle which includes:

    Hydrocortisone (Solu-Cortef): This medication will be given as an injection. It helps reduce inflammation in the body.

    Octreotide (Octreotide Lyomark 0.1 mg/ml): This will be given as an injection solution. It helps reduce the secretion of pancreatic enzymes that could cause complications.

    Teres ligament patch: This is a surgical technique where a piece of tissue is used to reinforce the surgical area.

  3. Step 3

    Post-Surgical Monitoring

    After surgery, you will be closely monitored for any complications. The medical team will be checking specifically for:

    Pancreatic fistula: An abnormal connection that allows pancreatic fluid to leak.

    Delayed gastric emptying: Slowed movement of food from the stomach to the small intestine.

    Post-pancreatectomy hemorrhage: Bleeding after the surgery.

    Chyle leakage: Leakage of lymphatic fluid.

    Bile leakage: Leakage of bile from the bile ducts.

    Acute pancreatitis: Inflammation of the remaining pancreas.

  4. Step 4

    Recovery Period

    Your recovery will be tracked to determine when you reach functional recovery, which means you can perform basic daily activities.

    The length of your hospital stay will depend on your recovery progress and any complications that may occur.

    If necessary, you might be admitted to the Intensive Care Unit (ICU) for closer monitoring.

  5. Step 5

    Follow-up Period

    After discharge from the hospital, you will be monitored for a follow-up period of 90 days.

    During this time, any readmissions to the hospital will be documented as part of the study.

    The study will track if you experience any adverse reactions to the medications or if any additional interventions (surgical, radiological, or endoscopic) are needed.

  6. Step 6

    Study Completion

    Your participation in the study will end after the 90-day follow-up period.

    The overall study is expected to run until May 2025, with final results available by May 2027.

Who can join the trial?

5 criteria

  • Age greater than 18 years
  • Planned elective pancreatoduodenectomy (a major surgery that removes the head of the pancreas, part of the small intestine, gallbladder, and bile duct)
  • Surgery can be either minimally invasive or open procedure
  • Surgery being performed for conditions such as pancreatic head carcinoma (cancer in the head portion of the pancreas) or intraductal papillary mucinous neoplasms (IPMN, which are growths in the ducts of the pancreas that can sometimes become cancerous)
  • Pancreatic duct diameter of 3mm or less as shown on preoperative CT scan or MRI

Who cannot join the trial?

9 criteria

  • You cannot participate if you have an allergy or a known sensitivity to any of the medications used in the study (hydrocortisone, octreotide, or teres patch).
  • If you have a current infection or have recently had an infection, you may not be eligible.
  • If you have diabetes that is not well-controlled, you may be excluded from the study.
  • If you are currently pregnant or breastfeeding, you cannot participate.
  • If you have severe liver disease or kidney disease, you may not be able to join the study.
  • If you are currently taking certain medications that might interact with the study drugs, you may be excluded.
  • If you have participated in another clinical trial within the past 30 days, you cannot join this study.
  • If you have a history of chronic pancreatitis (long-term inflammation of the pancreas), you may not be eligible.
  • If you have any condition that the study doctor believes would make it unsafe for you to participate, you will be excluded.
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Investigated drugs

  • Hydrocortisone

    is a steroid medication that helps reduce inflammation in the body. It is used in this trial as part of a combination treatment to help prevent complications after pancreas surgery.

  • Octreotide

    is a medication that reduces the production of certain hormones in the body, including those made by the pancreas. It can help prevent complications related to pancreatic secretions after surgery.

  • Teres ligament patch

    is a surgical technique where a piece of tissue called the teres ligament is used to reinforce the area where the pancreas is connected to other organs during surgery. This patch may help prevent leakage from the surgical connections.

What is already known about the treatment

  • Hydrocortisone

    A synthetic steroid medication administered intravenously during pancreatic surgery that helps reduce inflammation and the body's stress response. It works at the molecular level by binding to glucocorticoid receptors, which suppresses inflammatory pathways and immune responses. Hydrocortisone is classified as a corticosteroid and is widely established in medical literature for its anti-inflammatory properties. In the PANENCA trial, it's being studied as part of a bundle approach to prevent complications following pancreatoduodenectomy (Whipple procedure).

  • Octreotide

    A synthetic hormone medication given by injection that mimics the natural hormone somatostatin to reduce pancreatic secretions after surgery. It works by binding to somatostatin receptors, inhibiting the release of various hormones and decreasing pancreatic enzyme production. Octreotide is classified as a somatostatin analog and has been well-documented in medical literature for managing pancreatic fistulas and other complications. In the PANENCA trial, it's being evaluated as part of a comprehensive approach to reduce major complications after pancreatoduodenectomy.

  • Teres Ligament Patch

    A surgical technique that uses the patient's own teres ligament tissue as a reinforcement patch applied during pancreatoduodenectomy to strengthen surgical connections. It works by providing additional tissue support to reduce leakage at the surgical anastomosis sites. This approach is classified as an autologous tissue reinforcement method and has been described in surgical literature as a potential technique to reduce pancreatic fistula formation. In the PANENCA trial, the teres ligament patch is being studied as part of a bundle approach alongside hydrocortisone and octreotide to improve outcomes after pancreatic surgery.

Investigated diseases

  • Pancreatic head carcinoma

    A malignant tumor that forms in the head of the pancreas, the widest part of the pancreas that sits in the curve of the duodenum. As it grows, it often invades surrounding tissues and may block the bile duct, causing jaundice. The disease typically progresses silently in its early stages, with symptoms such as abdominal pain, weight loss, and digestive problems appearing as the tumor grows. Pancreatic head carcinoma can spread to nearby lymph nodes and other organs over time.

  • Intraductal papillary mucinous neoplasm (IPMN)

    A type of tumor that grows within the pancreatic ducts, characterized by papillary growths that produce mucin, a thick fluid. IPMNs can involve the main pancreatic duct, branch ducts, or both. They range from benign to malignant, with those in the main duct having higher potential for cancer development. Some IPMNs may cause symptoms such as abdominal pain, pancreatitis, or jaundice, while others remain asymptomatic. Over time, these neoplasms can progress and potentially transform into invasive pancreatic cancer.

  • Postoperative pancreatic fistula (POPF)

    A complication where pancreatic fluid leaks from the pancreatic anastomosis after pancreatic surgery. The condition occurs when there is a failure of healing at the site where the pancreas is connected to another organ. POPF is characterized by drainage of amylase-rich fluid from surgical drains or from abnormal collections near the pancreas. It can progress from a biochemical leak (Grade A) to clinically relevant fistulas (Grades B and C) that may require intervention.

  • Delayed gastric emptying (DGE)

    A condition following pancreatic surgery where the stomach takes longer than normal to empty its contents into the small intestine. Patients experience nausea, vomiting, bloating, and inability to tolerate oral intake. DGE can range from mild cases requiring minimal intervention to severe cases necessitating prolonged nasogastric tube drainage. The condition typically resolves over time but can significantly extend hospital stay and delay return to normal nutrition.

  • Post pancreatectomy hemorrhage (PPH)

    Bleeding that occurs after pancreatic surgery, which can be early (within 24 hours) or late (after 24 hours). It may originate from the surgical site or surrounding blood vessels. PPH ranges in severity from mild bleeding to life-threatening hemorrhage requiring urgent intervention. The bleeding can be intraluminal (into the digestive tract) or extraluminal (into the abdominal cavity), with varying clinical presentations depending on the location and extent.

  • Chyle leakage (CL)

    A complication following pancreatic surgery where lymphatic fluid (chyle) leaks into the abdominal cavity. It occurs due to disruption of lymphatic vessels during the operation, particularly when extensive lymph node dissection is performed. Chyle leakage is characterized by milky-appearing fluid in surgical drains, especially after fat-containing meals. The condition can lead to nutritional deficiencies and fluid imbalances if persistent.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519667-18-00Protocol code1.1Estimated enrolment460 patientsSponsorAmsterdam UMC Stichting

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).