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Whipple surgery aftermath: scientists track hidden changes in the remaining pancreas

NCT ID NCT07159672

Knowledge-focused Sponsor: Marco Aurélio Ribeiro, PhD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This completed study followed 44 adults who had Whipple surgery for cancers near the pancreas. Researchers measured changes in the remaining pancreas, including its size, metabolism, and nutrition levels, before surgery and at 3 and 6 months after. The goal was to learn how the body adapts after this major operation, which could help improve recovery care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors better understand how the pancreas changes after surgery, leading to improved nutritional care for patients.
What could go wrong
This is an observational study with only 44 participants, so findings may not apply to all patients. It does not test a new treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

44 people

The number who actually took part.

Started

Jul 2023

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population will consist of 44 individuals. The experimental group will include 24 adults aged 18-80 years with histologically or radiologically confirmed resectable periampullary malignant neoplasms (e.g., pancreatic head adenocarcinoma, ampullary carcinoma, distal cholangiocarcinoma, duodenal adenocarcinoma), undergoing pancreaticoduodenectomy (classic Whipple or pylorus-preserving), performed by the same institutional surgical team with standardized techniques (end-to-side duct-to-mucosa pancreaticojejunostomy). Participants will be evaluated at baseline (preoperative), 3 months, and 6 months post-discharge. The control group will include 20 age- and sex-matched individuals without gastrointestinal malignancy, selected among patients undergoing routine upper GI endoscopy with normal or nonspecific findings. Control subjects will be assessed once. All procedures will follow standardized clinical, nutritional, and laboratory protocols.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adults aged between 18 and 80 years; * Histologically or radiologically confirmed diagnosis of resectable periampullary malignant neoplasms (e.g., pancreatic head adenocarcinoma, ampullary carcinoma, distal cholangiocarcinoma, duodenal adenocarcinoma); * Candidates for elective pancreaticoduodenectomy (either classic Whipple or pylorus-preserving technique), performed by the institutional surgical team following standardized protocols; * ECOG Performance Status ≤2; * Adequate cardiopulmonary function to undergo major surgery, as assessed preoperatively; * Ability and willingness to provide written informed consent. Exclusion Criteria: * Previous pancreatic surgery; * Pancreaticoduodenectomy performed outside the study institution; * Evidence of unresectable disease, distant metastases, or local tumor recurrence at baseline imaging or intraoperative assessment; * Active inflammatory or autoimmune diseases (e.g., rheumatoid arthritis, lupus, inflammatory bowel disease); * Active malignancy other than periampullary cancer, or history of non-pancreatic cancer within the past 5 years; * Use of systemic immunosuppressive therapy (e.g., corticosteroids \>10 mg/day prednisone equivalent, chemotherapy, biologics); * Diagnosed malabsorption syndromes unrelated to pancreatic disease; * Severe hepatic dysfunction or severe renal impairment (eGFR \<30 mL/min/1.73m²); * Pregnancy or breastfeeding; * Refusal or inability to attend scheduled follow-up visits within 6 months;

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Conditions

The condition(s) this trial relates to.

carcinoma of the ampulla of vater distal biliary tract carcinoma duodenal adenocarcinoma malignant pancreatic neoplasm pancreatic adenocarcinoma pancreatic neoplasm periampullary adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pancreatic cancer Pancreaticoduodenectomy Periampullary neoplasms

Contacts and locations

Locations

  • Ribeirão Preto Medical School University of São Paulo

    Ribeirão Preto, São Paulo, 14.048-900, Brazil

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