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 study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oslo Universitetssykehus HF Oslo Norway
Stichting OLVG Amsterdam The Netherlands
University Hospital Maastricht Maastricht The Netherlands

Other Sites

Site Name City Country Status
Region Oestergoetland Linkoping Sweden
Isala Klinieken Stichting Zwolle The Netherlands
Jeroen Bosch Ziekenhuis Stichting s-Hertogenbosch The Netherlands
Medisch Spectrum Twente Enschede The Netherlands
Karolinska University Hospital Solna Sweden
Azienda Ospedaliera di Padova Padua Italy
Ospedale San Raffaele S.r.l. Milan Italy
Region Skane Skanes Universitetssjukhus Lund Sweden
Universita’ Degli Studi Di Verona Verona Italy
Catharina Ziekenhuis Stichting Eindhoven The Netherlands
Stichting Radboud University Medical Center Nijmegen The Netherlands
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Rigshospitalet Copenhagen Denmark
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Uklfrhnppjee Meqefdp Cadwlsy Gdmutpqjw Groningen The Netherlands
Abgjxoadp Uyi Amsterdam The Netherlands
Hololbuy Umwxctvlma Cllrahi Hropkiic Helsinki Finland
Euzaqrg Ufvdyvnkekfp Mnooiwr Cpdcudm Rcyrruxed (ohroiab Mgb Rotterdam The Netherlands
Uqhdrfnxmf On Arkcjrt Edegem Belgium
Lnzyj Unrdapnhalbh Mdjmwbc Cqgdock (atrfx Leiden The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
01.05.2025
Denmark Denmark
Not yet recruiting
01.05.2025
Finland Finland
Recruiting
01.05.2025
Italy Italy
Not yet recruiting
01.05.2025
Norway Norway
Recruiting
01.05.2025
Sweden Sweden
Recruiting
01.05.2025
The Netherlands The Netherlands
Recruiting
01.05.2025

Trial locations

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.

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.

Bile leakage (BL) – A complication where bile escapes from the biliary anastomosis or from injured bile ducts following pancreatic surgery. It is characterized by bilious fluid in surgical drains or collections. Bile leakage can range from small, self-limiting leaks to significant drainage requiring intervention. The condition may lead to localized or diffuse peritonitis if bile spreads throughout the abdominal cavity.

Post-pancreatectomy acute pancreatitis (PPAP) – Inflammation of the pancreatic remnant that occurs after partial removal of the pancreas. It is characterized by elevated pancreatic enzymes and typical symptoms of pancreatitis. PPAP results from manipulation of the pancreas during surgery, leading to activation of digestive enzymes within the gland. The condition ranges from mild, self-limiting inflammation to severe pancreatitis with potential complications such as necrosis or fluid collections.

Trial ID:
2024-519667-18-00
Protocol code:
1.1
Trial Phase:
Therapeutic confirmatory (Phase III)

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